Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00689351
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2008-05-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Sponsor:
Organization:
Raw JSON
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Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age.', 'description': 'Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': 'Infant Series 13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series).', 'otherNumAtRisk': 88, 'otherNumAffected': 78, 'seriousNumAtRisk': 88, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Infant Series 7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series).', 'otherNumAtRisk': 89, 'otherNumAffected': 75, 'seriousNumAtRisk': 89, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'After the Infant Series 13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month 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[{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hand-foot-and-mouth disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '99.7'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.6', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.2'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '8.2'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '57.5', 'groupId': 'OG001', 'lowerLimit': '45.9', 'upperLimit': '68.5'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '91.6', 'upperLimit': '99.7'}, {'value': '72.3', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '81.6'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '11.7'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Infant Immunogenicity population: participants who were 41 to 99 days of age (inclusive) on the day of the first vaccination, who had treatments as randomized (all expected doses) and at least 1 valid and determinate assay result for proposed analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.9'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '21.0'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '92.4', 'groupId': 'OG001', 'lowerLimit': '84.2', 'upperLimit': '97.2'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '95.7', 'upperLimit': '100.0'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '100.0'}, {'value': '23.6', 'groupId': 'OG001', 'lowerLimit': '13.2', 'upperLimit': '37.0'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.5', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Toddler Immunogenicity population:41-99 days old inclusive on day of first vaccination, 365-395 days old inclusive at toddler dose, had all treatments as randomized, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '5.40', 'groupId': 'OG000', 'lowerLimit': '4.62', 'upperLimit': '6.30'}, {'value': '6.97', 'groupId': 'OG001', 'lowerLimit': '5.94', 'upperLimit': '8.18'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '5.71', 'groupId': 'OG000', 'lowerLimit': '4.64', 'upperLimit': '7.03'}, {'value': '4.88', 'groupId': 'OG001', 'lowerLimit': '3.96', 'upperLimit': '6.01'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '3.33', 'groupId': 'OG000', 'lowerLimit': '2.90', 'upperLimit': '3.83'}, {'value': '3.78', 'groupId': 'OG001', 'lowerLimit': '3.31', 'upperLimit': '4.33'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '14.83', 'groupId': 'OG000', 'lowerLimit': '12.38', 'upperLimit': '17.77'}, {'value': '16.29', 'groupId': 'OG001', 'lowerLimit': '13.36', 'upperLimit': '19.85'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '5.24'}, {'value': '4.73', 'groupId': 'OG001', 'lowerLimit': '4.09', 'upperLimit': '5.47'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '3.88', 'groupId': 'OG000', 'lowerLimit': '3.18', 'upperLimit': '4.72'}, {'value': '4.20', 'groupId': 'OG001', 'lowerLimit': '3.55', 'upperLimit': '4.96'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '4.29', 'groupId': 'OG000', 'lowerLimit': '3.56', 'upperLimit': '5.16'}, {'value': '4.11', 'groupId': 'OG001', 'lowerLimit': '3.40', 'upperLimit': '4.98'}]}]}, {'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '7.44', 'groupId': 'OG000', 'lowerLimit': '6.25', 'upperLimit': '8.85'}, {'value': '0.02', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.03'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.60', 'groupId': 'OG000', 'lowerLimit': '1.35', 'upperLimit': '1.89'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.05'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '5.06', 'groupId': 'OG000', 'lowerLimit': '4.37', 'upperLimit': '5.85'}, {'value': '0.39', 'groupId': 'OG001', 'lowerLimit': '0.30', 'upperLimit': '0.49'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '5.73', 'groupId': 'OG000', 'lowerLimit': '4.64', 'upperLimit': '7.07'}, {'value': '0.64', 'groupId': 'OG001', 'lowerLimit': '0.49', 'upperLimit': '0.82'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '6.97', 'groupId': 'OG000', 'lowerLimit': '6.07', 'upperLimit': '8.00'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.05'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '5.94', 'groupId': 'OG000', 'lowerLimit': '5.13', 'upperLimit': '6.89'}, {'value': '2.65', 'groupId': 'OG001', 'lowerLimit': '2.29', 'upperLimit': '3.06'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.62', 'ciUpperLimit': '0.97', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.57', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.07', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.19', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.18', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.19', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.36', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '329.44', 'ciLowerLimit': '242.98', 'ciUpperLimit': '446.67', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.79', 'ciLowerLimit': '30.27', 'ciUpperLimit': '54.97', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.12', 'ciLowerLimit': '9.92', 'ciUpperLimit': '17.34', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.01', 'ciLowerLimit': '6.46', 'ciUpperLimit': '12.56', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '165.90', 'ciLowerLimit': '122.95', 'ciUpperLimit': '223.85', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.24', 'ciLowerLimit': '1.83', 'ciUpperLimit': '2.75', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'Mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Infant Immunogenicity Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '6.46', 'groupId': 'OG000', 'lowerLimit': '5.29', 'upperLimit': '7.90'}, {'value': '8.25', 'groupId': 'OG001', 'lowerLimit': '6.88', 'upperLimit': '9.89'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '16.81', 'groupId': 'OG000', 'lowerLimit': '14.36', 'upperLimit': '19.68'}, {'value': '15.14', 'groupId': 'OG001', 'lowerLimit': '11.91', 'upperLimit': '19.25'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '4.59', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '5.38'}, {'value': '4.83', 'groupId': 'OG001', 'lowerLimit': '4.12', 'upperLimit': '5.67'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '11.51', 'groupId': 'OG000', 'lowerLimit': '9.59', 'upperLimit': '13.80'}, {'value': '15.64', 'groupId': 'OG001', 'lowerLimit': '13.07', 'upperLimit': '18.72'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '6.86', 'groupId': 'OG000', 'lowerLimit': '5.67', 'upperLimit': '8.29'}, {'value': '7.44', 'groupId': 'OG001', 'lowerLimit': '6.27', 'upperLimit': '8.83'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '7.75', 'groupId': 'OG000', 'lowerLimit': '6.30', 'upperLimit': '9.53'}, {'value': '5.35', 'groupId': 'OG001', 'lowerLimit': '4.52', 'upperLimit': '6.33'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '10.95', 'groupId': 'OG000', 'lowerLimit': '8.77', 'upperLimit': '13.66'}, {'value': '10.44', 'groupId': 'OG001', 'lowerLimit': '8.60', 'upperLimit': '12.68'}]}]}, {'title': 'Serotype 1', 'categories': [{'measurements': [{'value': '9.29', 'groupId': 'OG000', 'lowerLimit': '7.65', 'upperLimit': '11.28'}, {'value': '0.04', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '0.05'}]}]}, {'title': 'Serotype 3', 'categories': [{'measurements': [{'value': '1.65', 'groupId': 'OG000', 'lowerLimit': '1.40', 'upperLimit': '1.95'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '0.13'}]}]}, {'title': 'Serotype 5', 'categories': [{'measurements': [{'value': '8.92', 'groupId': 'OG000', 'lowerLimit': '7.62', 'upperLimit': '10.45'}, {'value': '1.31', 'groupId': 'OG001', 'lowerLimit': '1.09', 'upperLimit': '1.56'}]}]}, {'title': 'Serotype 6A', 'categories': [{'measurements': [{'value': '13.58', 'groupId': 'OG000', 'lowerLimit': '11.28', 'upperLimit': '16.36'}, {'value': '3.33', 'groupId': 'OG001', 'lowerLimit': '2.67', 'upperLimit': '4.14'}]}]}, {'title': 'Serotype 7F', 'categories': [{'measurements': [{'value': '11.17', 'groupId': 'OG000', 'lowerLimit': '9.33', 'upperLimit': '13.37'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '0.07', 'upperLimit': '0.14'}]}]}, {'title': 'Serotype 19A', 'categories': [{'measurements': [{'value': '10.12', 'groupId': 'OG000', 'lowerLimit': '8.55', 'upperLimit': '11.98'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '2.78'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.02', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 4: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.48', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 6B: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.19', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 9V: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.95', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 14: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.19', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 18C: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '1.11', 'ciUpperLimit': '1.88', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 19F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.40', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 23F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '234.33', 'ciLowerLimit': '176.33', 'ciUpperLimit': '311.41', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 1: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.63', 'ciLowerLimit': '12.19', 'ciUpperLimit': '22.69', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 3: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.84', 'ciLowerLimit': '5.39', 'ciUpperLimit': '8.67', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 5: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.08', 'ciLowerLimit': '3.07', 'ciUpperLimit': '5.43', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 6A: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '110.92', 'ciLowerLimit': '77.09', 'ciUpperLimit': '159.59', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 7F: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.25', 'ciLowerLimit': '3.39', 'ciUpperLimit': '5.33', 'estimateComment': 'CI for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC, 7vPnC).', 'groupDescription': 'Serotype 19A: Ratio of geometric means (13vPnC, 7vPnC)', 'statisticalMethod': 'Student t distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Geometric mean ratio computed using Student t distribution for the mean difference of the measures on the log scale.', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the Toddler Dose (13 months of age)', 'description': 'Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.', 'unitOfMeasure': 'Mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Toddler Immunogenicity Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness: Any (n=23,26)', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '34.2', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=6,2)', 'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Any (n=14,18)', 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Mild (n=8,18)', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Moderate (n=7,4)', 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Any (n=27,22)', 'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Mild (n=23,19)', 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '25.3', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Moderate (n=4,3)', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}, {'value': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.862', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.157', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for significant tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.550', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.366', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.301', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.362', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.718', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 1 (2 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \\[\\>\\] 7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: All participants who received at least 1 dose of the study vaccine; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness: Any (n=23,24)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=0,3)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Any (n=22,18)', 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000'}, {'value': '28.6', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Mild (n=18,15)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Moderate (n=4,4)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Any (n=20,25)', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '38.5', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Mild (n=18,24)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '36.9', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Moderate (n=4,3)', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for significant tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.447', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.578', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.451', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.712', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 2 (4 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness: Any (n=15,16)', 'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000'}, {'value': '27.1', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=0,1)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Any (n=18,14)', 'categories': [{'measurements': [{'value': '27.7', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Mild (n=13,13)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '22.0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Moderate (n=7,4)', 'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Any (n=19,16)', 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Mild (n=12,15)', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Moderate (n=7,3)', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.681', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.482', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for significant tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.683', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.533', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.692', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.331', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 3 (6 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Tenderness: Any (n=19,14)', 'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}, {'title': 'Tenderness: Significant (n=3,1)', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Any (n=11,10)', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000'}, {'value': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Mild (n=4,7)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}, {'value': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Moderate (n=9,4)', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Swelling: Severe (n=1,0)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Any (n=15,12)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Mild (n=9,10)', 'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}]}]}, {'title': 'Redness: Moderate (n=8,3)', 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.409', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.617', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for significant tenderness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.807', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.144', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.495', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for severe swelling.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.506', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for any redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for mild redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.200', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for moderate redness.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after toddler dose (12 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the specific characteristic.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Fever ≥38 degrees C but ≤39 degrees C (n=11,9)', 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=23,22)', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}, {'value': '28.9', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=38,56)', 'categories': [{'measurements': [{'value': '49.4', 'groupId': 'OG000'}, {'value': '70.9', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=37,30)', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '39.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=28,38)', 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.633', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever ≥38 degrees C but but less than or equal to (≤)39 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.721', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased appetite.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for irritability.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.253', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for increased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 1 (2 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Fever ≥38 degrees C but ≤39 degrees C (n=6,8)', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=16,28)', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=25,36)', 'categories': [{'measurements': [{'value': '40.3', 'groupId': 'OG000'}, {'value': '53.7', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=17,16)', 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=18,27)', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}, {'value': '40.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.781', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.060', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased appetite.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for irritability.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for increased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.264', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 2 (4 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Fever ≥38 degrees C but ≤39 degrees C (n=8,5)', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 degrees C but ≤40 degrees C (n=0,1)', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=14,16)', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '28.1', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=13,25)', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=18,12)', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000'}, {'value': '21.1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=10,17)', 'categories': [{'measurements': [{'value': '16.4', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.563', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.468', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever \\>39 degrees C but ≤40 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.535', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased appetite.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for irritability.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.398', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for increased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.125', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after dose 3 (6 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'OG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'classes': [{'title': 'Fever ≥38 degrees C but ≤39 degrees C (n=7,10)', 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000'}, {'value': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Fever >39 degrees C but ≤40 degrees C (n=1,0)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite (n=13,15)', 'categories': [{'measurements': [{'value': '22.8', 'groupId': 'OG000'}, {'value': '27.8', 'groupId': 'OG001'}]}]}, {'title': 'Irritability (n=18,21)', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'Increased sleep (n=11,8)', 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Decreased sleep (n=11,20)', 'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000'}, {'value': '34.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.596', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever ≥38 degrees C but ≤39 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for fever \\>39 degrees C but ≤40 degrees C.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.663', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased appetite.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for irritability.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.613', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for increased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.138', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison between treatments for decreased sleep.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Within 4 days after toddler dose (12 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety; N=number of participants reporting yes for at least 1 day or no for all days; n=number of participants reporting the event.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'FG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}], 'periods': [{'title': 'Infant Series of Dosing', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Vaccinated Dose 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'Vaccinated Dose 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Vaccinated Dose 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Parent/legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'After Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Parent/legal guardian request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '13vPnC', 'description': '13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'BG001', 'title': '7vPnC', 'description': '7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.3', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '0.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-24', 'studyFirstSubmitDate': '2008-05-29', 'resultsFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-10', 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.'}, {'measure': 'Geometric Mean Concentration (GMC) of Serotype-specific IgG Antibody 1 Month After the Toddler Dose', 'timeFrame': '1 month after the Toddler Dose (13 months of age)', 'description': 'Antibody GMC along with corresponding 2-sided 95% CI for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Geometric mean concentrations (GMCs) were calculated using all participants with available data for the specified blood draw.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 4 days after dose 1 (2 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \\[cm\\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than \\[\\>\\] 7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 4 days after dose 2 (4 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 4 days after dose 3 (6 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 4 days after toddler dose (12 months of age)', 'description': 'Pre-specified local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 cm to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\\>7.0 cm). Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age)', 'timeFrame': 'Within 4 days after dose 1 (2 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age)', 'timeFrame': 'Within 4 days after dose 2 (4 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age)', 'timeFrame': 'Within 4 days after dose 3 (6 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.'}, {'measure': 'Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age)', 'timeFrame': 'Within 4 days after toddler dose (12 months of age)', 'description': 'Pre-specified systemic events (any fever ≥ 38 degrees Celsius \\[C\\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Serotype-specific Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After the Infant Series', 'timeFrame': '1 month after the infant series (7 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35 Mcg/mL along with the corresponding 95 percent (%) confidence interval (CI) was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Serotype-specific IgG Antibody Level ≥0.35 Mcg/mL Measured 1 Month After the Toddler Dose', 'timeFrame': '1 month after the toddler dose (13 months of age)', 'description': 'Percentage of participants achieving predefined antibody threshold ≥0.35Mcg/mL along with the corresponding 95% CI was calculated for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A). Exact 2-sided CI was based on the observed percentage of participants.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prevention', 'against', 'pneumococcal', 'disease', 'Vaccine'], 'conditions': ['Pneumococcal Vaccine']}, 'referencesModule': {'references': [{'pmid': '23011012', 'type': 'DERIVED', 'citation': 'Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=6096A1-010&StudyName=Study%20Evaluating%20A%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20Administered%20To%20Infants%20In%20Korea', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '98 Days', 'minimumAge': '42 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy 2-month-old-infants (42 to 98 days)\n* Available for the entire study period (14 months)\n\nExclusion Criteria:\n\n* Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine\n* A previous severe reaction to any vaccine or vaccine-related component'}, 'identificationModule': {'nctId': 'NCT00689351', 'briefTitle': 'Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea', 'orgStudyIdInfo': {'id': '6096A1-010'}, 'secondaryIdInfos': [{'id': 'B1851001'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '13vPnC', 'interventionNames': ['Biological: 13-valent pneumococcal conjugate vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '7vPnC', 'interventionNames': ['Biological: 7-valent pneumococcal conjugate vaccine']}], 'interventions': [{'name': '13-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.', 'armGroupLabels': ['1']}, {'name': '7-valent pneumococcal conjugate vaccine', 'type': 'BIOLOGICAL', 'description': '7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400-711', 'city': 'Incheon', 'state': 'Bupyeong-gu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-744', 'city': 'Seoul', 'state': 'Jongno-gu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '400-711', 'city': 'Incheon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '412-270', 'city': 'Kyunggi', 'state': 'Koyang', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site'}, {'zip': '120-752', 'city': 'Seoul', 'state': 'Seodaemun-gu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-950', 'city': 'Seoul', 'state': 'Yeongdeungpo-gu', 'country': 'South Korea', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Wyeth, Inc'}}}}