Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT00952367
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}], 'ancestors': [{'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Wyeth has the right to review disclosures, requesting a delay of less than 60 days. 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': {'eventGroups': [{'id': 'EG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.', 'otherNumAtRisk': 3600, 'otherNumAffected': 0, 'seriousNumAtRisk': 3600, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Beijing (n=600)', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Shanghai (n=614)', 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'Jinan (n=594)', 'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000'}]}]}, {'title': 'Nanjing (n=598)', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Wuhan (n=596)', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}, {'title': 'Dongguan (n=598)', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Serotypes of Streptococcus Pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': '19F', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000'}]}]}, {'title': '14', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}]}]}, {'title': '19A', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': '15', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': '6B', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'NO6A/NO6B', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': '17', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'NO23F', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}]}]}, {'title': '18', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}]}]}, {'title': '10', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': '8', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '11', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': '20', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '22', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': '33', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': '7', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': '9', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'NO19A/NO19F', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'G', 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}]}]}, {'title': 'H', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'D', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'I', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'E', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'F', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'NO(Without capsule)', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': '23F', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}, {'title': '6A', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Beijing (n=600)', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Shanghai (n=614)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}]}]}, {'title': 'Jinan (n=594)', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Nanjing (n=598)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Wuhan (n=596)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Dongguan (n=598)', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. n=number of participants analyzed at that site.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Beijing (n=600)', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Shanghai (n=614)', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Jinan (n=594)', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Nanjing (n=598)', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}, {'title': 'Wuhan (n=596)', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Dongguan (n=598)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. n=number of participants analyzed at that site.'}, {'type': 'SECONDARY', 'title': 'Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Penicillin (Old Criteria)', 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}]}]}, {'title': 'Penicillin', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Amoxicillin/clavulanic acid', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Cefuroxime', 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}]}]}, {'title': 'Cefatriaxone', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Azithromycin', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}, {'title': 'Erythromycin', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000'}]}]}, {'title': 'Levofloxacin', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Moxifloxacin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.', 'unitOfMeasure': 'percentage of isolates', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae.'}, {'type': 'SECONDARY', 'title': 'Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Cefuroxime', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cefatriaxone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Azithromycin', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Levofloxacin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Moxifloxacin', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Ampicillin', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics.', 'unitOfMeasure': 'percentage of isolates', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B.'}, {'type': 'SECONDARY', 'title': 'Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Cefuroxime', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Cefatriaxone', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Azithromycin', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000'}]}]}, {'title': 'Levofloxacin', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Erythromycin', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics.', 'unitOfMeasure': 'percentage of isolates', 'reportingStatus': 'POSTED', 'populationDescription': 'PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis.'}, {'type': 'SECONDARY', 'title': 'Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Age of mother bearing, <=30 years vs >30 years', 'categories': [{'measurements': [{'value': '0.248', 'spread': '0.070', 'groupId': 'OG000'}]}]}, {'title': 'Household register, local vs nonlocal', 'categories': [{'measurements': [{'value': '-0.116', 'spread': '0.062', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, illiteracy vs postgraduate", 'categories': [{'measurements': [{'value': '1.087', 'spread': '0.396', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, elementary vs postgraduate", 'categories': [{'measurements': [{'value': '0.326', 'spread': '0.199', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, junior middle vs postgraduate", 'categories': [{'measurements': [{'value': '0.209', 'spread': '0.149', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, senior high vs postgraduate", 'categories': [{'measurements': [{'value': '-0.068', 'spread': '0.157', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, college vs postgraduate", 'categories': [{'measurements': [{'value': '-0.643', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'Monthly income, <600 RMB vs >=10000 RMB', 'categories': [{'measurements': [{'value': '0.508', 'spread': '0.251', 'groupId': 'OG000'}]}]}, {'title': 'Monthly income, 600 to 1999 RMB vs >= 10000 RMB', 'categories': [{'measurements': [{'value': '0.448', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'Monthly income, 2000 to 4999 RMB vs >= 10000 RMB', 'categories': [{'measurements': [{'value': '0.396', 'spread': '0.172', 'groupId': 'OG000'}]}]}, {'title': 'Monthly income, 5000-7999 RMB vs >= 10000 RMB', 'categories': [{'measurements': [{'value': '-0.230', 'spread': '0.254', 'groupId': 'OG000'}]}]}, {'title': 'Monthly income, 8000 to 9999 RMB vs >= 10000 RMB', 'categories': [{'measurements': [{'value': '-0.834', 'spread': '0.615', 'groupId': 'OG000'}]}]}, {'title': 'Whether have brothers or sisters, no vs yes', 'categories': [{'measurements': [{'value': '-0.331', 'spread': '0.065', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.641', 'ciLowerLimit': '1.247', 'ciUpperLimit': '2.159', 'groupDescription': 'Age of mother bearing, \\<=30 years vs \\>30 years', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=12.514', 'testedNonInferiority': False}, {'pValue': '0.060', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.793', 'ciLowerLimit': '0.622', 'ciUpperLimit': '1.010', 'groupDescription': 'Household register, local vs nonlocal', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=3.529', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.369', 'ciLowerLimit': '1.672', 'ciUpperLimit': '32.479', 'groupDescription': "Mother's education level, illiteracy vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=7.524', 'testedNonInferiority': False}, {'pValue': '0.102', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.443', 'ciLowerLimit': '1.001', 'ciUpperLimit': '11.843', 'groupDescription': "Mother's education level, elementary school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=2.671', 'testedNonInferiority': False}, {'pValue': '0.159', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.064', 'ciLowerLimit': '0.933', 'ciUpperLimit': '10.067', 'groupDescription': "Mother's education level, junior middle school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=1.984', 'testedNonInferiority': False}, {'pValue': '0.662', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.321', 'ciLowerLimit': '0.710', 'ciUpperLimit': '7.589', 'groupDescription': "Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.191', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.306', 'ciLowerLimit': '0.399', 'ciUpperLimit': '4.277', 'groupDescription': "Mother's education level, college/university vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=13.525', 'testedNonInferiority': False}, {'pValue': '0.043', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.217', 'ciLowerLimit': '0.719', 'ciUpperLimit': '6.831', 'groupDescription': 'Family monthly income per capita, \\<=600 RMB vs \\>=10000 RMB', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=4.095', 'testedNonInferiority': False}, {'pValue': '0.010', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.089', 'ciLowerLimit': '0.739', 'ciUpperLimit': '5.906', 'groupDescription': 'Family monthly income per capita, 600 to 1999 RMB vs \\>=10000 RMB', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=6.549', 'testedNonInferiority': False}, {'pValue': '0.021', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.983', 'ciLowerLimit': '0.704', 'ciUpperLimit': '5.583', 'groupDescription': 'Family monthly income per capita, 2000 to 4999 RMB vs \\>=10000 RMB', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=5.313', 'testedNonInferiority': False}, {'pValue': '0.364', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.060', 'ciLowerLimit': '0.344', 'ciUpperLimit': '3.267', 'groupDescription': 'Family monthly income per capita, 5000 to 7999 RMB vs \\>=10000 RMB', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.824', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.580', 'ciLowerLimit': '0.100', 'ciUpperLimit': '3.347', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=1.838', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.516', 'ciLowerLimit': '0.400', 'ciUpperLimit': '0.666', 'groupDescription': 'Whether have brothers or sisters, no vs yes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=25.960', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Risk factors include age of mother bearing (less than or equal to \\[\\<=\\] 30 years versus \\[vs\\] more than \\[\\>\\] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi \\[RMB\\], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to \\[\\>=\\] 10000 RMB); whether have brothers or sisters (yes vs no).", 'unitOfMeasure': 'relative risk', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Birth information, preterm vs full-term birth', 'categories': [{'measurements': [{'value': '-0.683', 'spread': '0.359', 'groupId': 'OG000'}]}]}, {'title': 'Household register, local vs nonlocal', 'categories': [{'measurements': [{'value': '-0.204', 'spread': '0.099', 'groupId': 'OG000'}]}]}, {'title': 'Feeding, pure breast feeding vs pure formula milk', 'categories': [{'measurements': [{'value': '0.227', 'spread': '0.113', 'groupId': 'OG000'}]}]}, {'title': 'Feeding, mixed feeding vs pure formula milk', 'categories': [{'measurements': [{'value': '-0.287', 'spread': '0.138', 'groupId': 'OG000'}]}]}, {'title': "Father's education, illiteracy vs postgraduate", 'categories': [{'measurements': [{'value': '2.857', 'spread': '1.047', 'groupId': 'OG000'}]}]}, {'title': "Father's education, elementary vs postgraduate", 'categories': [{'measurements': [{'value': '-0.126', 'spread': '0.448', 'groupId': 'OG000'}]}]}, {'title': "Father's education, junior middle vs postgraduate", 'categories': [{'measurements': [{'value': '-0.093', 'spread': '0.298', 'groupId': 'OG000'}]}]}, {'title': "Father's education, senior high vs postgraduate", 'categories': [{'measurements': [{'value': '-0.411', 'spread': '0.306', 'groupId': 'OG000'}]}]}, {'title': "Father's education, college vs postgraduate", 'categories': [{'measurements': [{'value': '-0.559', 'spread': '0.316', 'groupId': 'OG000'}]}]}, {'title': 'Living space per capita, continuous variables', 'categories': [{'measurements': [{'value': '-0.016', 'spread': '0.009', 'groupId': 'OG000'}]}]}, {'title': 'Vaccination history of Hib, no vs yes', 'categories': [{'measurements': [{'value': '-0.158', 'spread': '0.085', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.255', 'ciLowerLimit': '0.062', 'ciUpperLimit': '1.044', 'groupDescription': 'Birth information, preterm birth vs full-term birth', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=3.610', 'testedNonInferiority': False}, {'pValue': '0.040', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.666', 'ciLowerLimit': '0.451', 'ciUpperLimit': '0.981', 'groupDescription': 'Household register, local vs nonlocal', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=4.228', 'testedNonInferiority': False}, {'pValue': '0.044', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.182', 'ciLowerLimit': '0.758', 'ciUpperLimit': '1.844', 'groupDescription': 'Feeding manners within 6 months, pure breast feeding vs pure formula milk feeding', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=4.074', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.707', 'ciLowerLimit': '0.420', 'ciUpperLimit': '1.191', 'groupDescription': 'Feeding manners within 6 months, mixed feeding vs pure formula milk feeding', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=4.316', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.229', 'ciLowerLimit': '3.993', 'ciUpperLimit': '2130.500', 'groupDescription': "Father's education level, illiteracy vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=7.438', 'testedNonInferiority': False}, {'pValue': '0.778', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.671', 'ciLowerLimit': '0.537', 'ciUpperLimit': '40.608', 'groupDescription': "Father's education level, elementary school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.079', 'testedNonInferiority': False}, {'pValue': '0.756', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.830', 'ciLowerLimit': '0.649', 'ciUpperLimit': '35.956', 'groupDescription': "Father's education level, junior high school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.096', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.513', 'ciLowerLimit': '0.474', 'ciUpperLimit': '26.030', 'groupDescription': "Father's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=1.807', 'testedNonInferiority': False}, {'pValue': '0.077', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.029', 'ciLowerLimit': '0.412', 'ciUpperLimit': '22.292', 'groupDescription': "Father's education level, college/university vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=3.131', 'testedNonInferiority': False}, {'pValue': '0.056', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.984', 'ciLowerLimit': '0.968', 'ciUpperLimit': '1.000', 'groupDescription': 'Living space per capita, continuous variables', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=3.648', 'testedNonInferiority': False}, {'pValue': '0.064', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.729', 'ciLowerLimit': '0.522', 'ciUpperLimit': '1.018', 'groupDescription': 'Vaccination history of Hib, no vs yes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=3.432', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).", 'unitOfMeasure': 'relative risk', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Per-protocol Population', 'description': 'Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'classes': [{'title': 'Birth information, preterm vs full-term birth', 'categories': [{'measurements': [{'value': '-0.412', 'spread': '0.175', 'groupId': 'OG000'}]}]}, {'title': 'Household register, local vs nonlocal', 'categories': [{'measurements': [{'value': '-0.303', 'spread': '0.065', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, illiteracy vs graduate", 'categories': [{'measurements': [{'value': '0.280', 'spread': '0.479', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, elementary vs graduate", 'categories': [{'measurements': [{'value': '0.104', 'spread': '0.214', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, junior middle vs graduate", 'categories': [{'measurements': [{'value': '0.199', 'spread': '0.153', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, senior high vs postgraduate", 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.159', 'groupId': 'OG000'}]}]}, {'title': "Mother's education, college vs postgraduate", 'categories': [{'measurements': [{'value': '-0.270', 'spread': '0.174', 'groupId': 'OG000'}]}]}, {'title': 'Whether have brothers or sisters, no vs yes', 'categories': [{'measurements': [{'value': '-0.203', 'spread': '0.063', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.438', 'ciLowerLimit': '0.221', 'ciUpperLimit': '0.871', 'groupDescription': 'Birth information, preterm birth vs full-term birth', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=5.538', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.546', 'ciLowerLimit': '0.423', 'ciUpperLimit': '0.703', 'groupDescription': 'Household register, local vs nonlocal', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=21.938', 'testedNonInferiority': False}, {'pValue': '0.559', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.137', 'ciLowerLimit': '0.473', 'ciUpperLimit': '9.652', 'groupDescription': "Mother's education level, illiteracy vs graduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.341', 'testedNonInferiority': False}, {'pValue': '0.626', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.793', 'ciLowerLimit': '0.596', 'ciUpperLimit': '5.394', 'groupDescription': "Mother's education level, elementary school vs graduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=0.238', 'testedNonInferiority': False}, {'pValue': '0.193', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.972', 'ciLowerLimit': '0.699', 'ciUpperLimit': '5.562', 'groupDescription': "Mother's education level, junior middle school vs graduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=1.691', 'testedNonInferiority': False}, {'pValue': '0.298', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.907', 'ciLowerLimit': '0.679', 'ciUpperLimit': '5.353', 'groupDescription': "Mother's education level, senior high school/vocational high school/technical secondary school vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=1.081', 'testedNonInferiority': False}, {'pValue': '0.122', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.233', 'ciLowerLimit': '0.439', 'ciUpperLimit': '3.464', 'groupDescription': "Mother's education level, college/university vs postgraduate or above", 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=2.395', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.666', 'ciLowerLimit': '0.520', 'ciUpperLimit': '0.855', 'groupDescription': 'Whether have brothers or sisters, no vs yes', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Degrees of freedom=1, Wald Chi-Square=10.233', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).", 'unitOfMeasure': 'relative risk', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Participants', 'description': 'Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3641'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3635'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Noncoordination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3600', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Per-protocol Population', 'description': 'In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '2.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1718', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1882', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Nasopharyngeal swab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3641}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-12', 'studyFirstSubmitDate': '2009-08-03', 'resultsFirstSubmitDate': '2012-03-12', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-03-12', 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.'}, {'measure': 'Percentage of Participants With Serotypes of Streptococcus Pneumoniae', 'timeFrame': 'Day 1', 'description': 'Categories are the serotypes of Streptococcus pneumoniae. NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B. NO23F belongs to Group 23 but is not 23F. NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F. Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction. NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.'}, {'measure': 'Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis', 'timeFrame': 'Day 1', 'description': 'A nasopharyngeal swab sample approached via the nasal route was collected. Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.'}, {'measure': 'Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics. Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008. Criteria in CLSI before 2008 were the old criteria.'}, {'measure': 'Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics.'}, {'measure': 'Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics', 'timeFrame': 'Day 1', 'description': 'Categories are types of antibiotics.'}, {'measure': 'Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae', 'timeFrame': 'Day 1', 'description': "Risk factors include age of mother bearing (less than or equal to \\[\\<=\\] 30 years versus \\[vs\\] more than \\[\\>\\] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi \\[RMB\\], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to \\[\\>=\\] 10000 RMB); whether have brothers or sisters (yes vs no)."}, {'measure': 'Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B', 'timeFrame': 'Day 1', 'description': "Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes)."}, {'measure': 'Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis', 'timeFrame': 'Day 1', 'description': "Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Streptococcus Pneumoniae Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0887X1-4602&StudyName=Prevalence%20of%20Nasopharyngeal%20Carriage%20of%20Streptococcus%20Pneumoniae%20in%20Healthy%20Children%20of%2012-18%20Months%20in%206%20Cities%2C%20China', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children. The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested. Potential risk factors for nasopharyngeal carriage will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Children 12 to 18 months old', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Healthy children aged 12-18 months\n\nExclusion Criteria\n\n* Use of antibiotics up to 15 days prior to study inclusion\n* Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible\n* Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion.\n* Received any pneumococcal vaccine in the past.\n* Children who have already provided a NP sample in the same study period.\n* Any relevant hemorrhagic disorder.\n* Any febrile process (fever ≥ 38°C) at time of screening.'}, 'identificationModule': {'nctId': 'NCT00952367', 'briefTitle': 'Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China', 'orgStudyIdInfo': {'id': '0887X1-4602'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Per-protocol population', 'description': 'In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.', 'interventionNames': ['Other: Nasopharyngeal swab']}], 'interventions': [{'name': 'Nasopharyngeal swab', 'type': 'OTHER', 'description': 'Nasopharyngeal swab', 'armGroupLabels': ['Per-protocol population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10013', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '523016', 'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '430015', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '210003', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '250001', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200336', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], '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': {'type': 'SPONSOR'}}}}