Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-20 @ 6:49 AM
Study NCT ID:
NCT02447718
Status:
COMPLETED
Last Update Posted:
2022-06-24
First Post:
2015-05-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaccinating Children After Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414006', 'term': '23-valent pneumococcal capsular polysaccharide vaccine'}, {'id': 'C541234', 'term': 'diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karina.top@dal.ca', 'phone': '902-470-6343', 'title': 'Dr. Karina Top', 'organization': 'IWK Health Centre'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1. Antibody levels to vaccine antigens were not measured before chemotherapy, cannot confirm that chemotherapy was the cause of low postchemotherapy titers.\n2. Immunization status at ALL diagnosis was not assessed and therefore could not confirm whether postchemotherapy participants were underimmunized for age before diagnosis relative to their peers.\n3. We were unable to assess antibodies to other pertussis antigens (eg, filamentous hemagglutinin, pertactin), only anti-PT antibodies alone.'}}, 'adverseEventsModule': {'timeFrame': 'AEFI was captured through structured telephone interviews on days 8-10 and 30-33 after each immunization', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse Events were not monitored for Healthy Controls as they did not receive the interventions, they provided baseline data only.", 'eventGroups': [{'id': 'EG000', 'title': 'DTaP-IPV-HiB+PCV13', 'description': 'DTaP-IPV-Hib: diphtheria-tetanus-acellular pertussis-inactivated polio-H. influenzae type b vaccine\n\nPCV13: 13-valent pneumococcal conjugate vaccine', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 56, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PPV23', 'description': 'PPV23: 23-valent pneumococcal polysaccharide vaccine', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 46, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pain/erythema/swelling at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 45}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Systemic symptoms', 'notes': 'Systemic symptoms included fever, malaise, gastrointestinal symptoms, skin rash, headache, pharyngitis, otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 73, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}], 'classes': [{'title': '2 months post-PCV13', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': '12-15 months post-PCV13', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-vaccination Baseline, 2 months and 12-15 months', 'description': 'The percentage of participants with protective titres (with protective level defined as ≥0.35 ug/ml, as per World Health Organization criteria) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed equaled the overall number of ALL participants that completed the study and had analyzable serology collected at 2 months and 12-15 months post-vaccination.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Protective Titres to PCV7 Serotypes at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0', 'description': 'The number of participants with protective titres (≥0.35 ug/ml) to PCV7 serotypes at baseline will be compared to age-matched controls.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'classes': [{'title': 'Pneumococcal Serotype 1', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.22'}, {'value': '0.52', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.66'}]}]}, {'title': 'Pneumococcal Serotype 3', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.21'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.72', 'upperLimit': '1.42'}]}]}, {'title': 'Pneumococcal Serotype 4', 'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.22'}, {'value': '0.54', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '0.68'}]}]}, {'title': 'Pneumococcal Serotype 6B', 'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '0.50'}, {'value': '1.20', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.57'}]}]}, {'title': 'Pneumococcal Serotype 7F', 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.33'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.57', 'upperLimit': '0.87'}]}]}, {'title': 'Pneumococcal Serotype 9V', 'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.37', 'upperLimit': '0.55'}, {'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.10'}]}]}, {'title': 'Pneumococcal Serotype 14', 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000', 'lowerLimit': '0.35', 'upperLimit': '0.59'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '2.50'}]}]}, {'title': 'Pneumococcal Serotype 18C', 'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.27'}, {'value': '0.49', 'groupId': 'OG001', 'lowerLimit': '0.38', 'upperLimit': '0.62'}]}]}, {'title': 'Pneumococcal Serotype 19F', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.26'}, {'value': '3.21', 'groupId': 'OG001', 'lowerLimit': '2.73', 'upperLimit': '3.76'}]}]}, {'title': 'Pneumococcal Serotype 23F', 'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.36'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '1.52'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (GMT) and percentage of subjects with protective titres to pneumococcal serotypes in children with ALL versus age-matched controls.', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13 Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}], 'classes': [{'title': 'Pre-vaccination Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000', 'lowerLimit': '3.67', 'upperLimit': '4.58'}]}]}, {'title': 'Baseline - 2 months post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.67', 'groupId': 'OG000', 'lowerLimit': '22.25', 'upperLimit': '42.29'}]}]}, {'title': 'Baseline - 12-15 months post-vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.39', 'groupId': 'OG000', 'lowerLimit': '7.76', 'upperLimit': '13.91'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prevaccination baseline, 2 months, 12-15 months', 'description': 'Baseline, Short-term (baseline - 2 months after vaccination) and long-term (baseline - 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMT ratios.', 'unitOfMeasure': 'EU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 73 participants received DTaP-IPV-Hib, 67 provided a follow up sample at 2 months post-vaccination and 66 provided a follow up sample at 12 months post-vaccination.'}, {'type': 'SECONDARY', 'title': 'Baseline Tetanus Toxoid Antibody Titers in Children With ALL Versus Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.20'}, {'value': '1.73', 'groupId': 'OG001', 'lowerLimit': '1.26', 'upperLimit': '2.37'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls', 'unitOfMeasure': 'IU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Pertussis Toxin Titers in Children With ALL Versus Healthy Controls', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'groupId': 'OG000', 'lowerLimit': '3.67', 'upperLimit': '4.58'}, {'value': '10.35', 'groupId': 'OG001', 'lowerLimit': '8.15', 'upperLimit': '13.16'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls', 'unitOfMeasure': 'EU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Baseline Varicella Titers in Children With ALL Versus Controls.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'OG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'groupId': 'OG000', 'lowerLimit': '0.24', 'upperLimit': '0.45'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.77', 'upperLimit': '1.29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 0', 'description': 'Geometric mean titers (95% confidence interval) in AI (antibody index)', 'unitOfMeasure': 'Antibody index', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13 Pediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}], 'classes': [{'title': 'Pre-vaccination Baseline', 'categories': [{'measurements': [{'value': '0.16', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.20'}]}]}, {'title': 'Baseline - 2 months post-vaccination', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '2.57', 'upperLimit': '6.22'}]}]}, {'title': 'Baseline - 12-15 months post-vaccination', 'categories': [{'measurements': [{'value': '1.08', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.52'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'baseline, 2 months, 12-15 months', 'description': 'Baseline, short-term (baseline to 2 months after vaccination) and long-term (baseline to 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMTs with 95% confidence intervals', 'unitOfMeasure': 'IU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with analyzable data at each timepoint were included'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}], 'classes': [{'categories': [{'title': 'Possibly related to vaccination', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unrelated to vaccination', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No AEFI requiring healthcare visit or leading to >=1 day of disability', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'days 8-10 and 30-33', 'description': 'Adverse Events Following Immunization requiring healthcare visit or leading to \\>=1 day of disability will be captured through structured telephone interviews on days 8-10 and 30-33 after each immunization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'FG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'Received Prevnar®13', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'comment': 'Do not receive vaccination', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Pediacel®', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'comment': 'Do not receive vaccination', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Pneumovax® 23', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'comment': 'Do not receive vaccination', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral across 10 pediatric centres. Controls were recruited at 3 centres. Participants were enrolled between November 2015 to September 2017.', 'preAssignmentDetails': '155 of the 156 participants recruited met inclusion criteria. Of the 78 participants with ALL recruited, 1 did not meet inclusion criteria and 3 withdrew consent prior to study start. All of the 78 control participants met inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.\n\nPrevnar®13: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.\n\nPneumovax® 23: A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13\n\nPediacel®: A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.'}, {'id': 'BG001', 'title': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'BG000', 'lowerLimit': '3.8', 'upperLimit': '19.3'}, {'value': '8.3', 'groupId': 'BG001', 'lowerLimit': '3.5', 'upperLimit': '18.9'}, {'value': '8.2', 'groupId': 'BG002', 'lowerLimit': '3.5', 'upperLimit': '19.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ALL disease risk category', 'classes': [{'title': 'Standard risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'High risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Very high risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Disease risk category based on patient characteristics at leukemia diagnosis reflects intensity of chemotherapy', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only collected for ALL participants'}, {'title': 'Treatment Protocol', 'classes': [{'title': "Children's Oncology Group", 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Dana Farber Cancer Institute', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only collected for ALL participants'}, {'title': 'Interval from last chemotherapy to serology', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '10'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'description': 'Time in months between last chemotherapy session to baseline blood draw.', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Only collected for ALL participants'}, {'title': 'Total white blood cell count at enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '5.3', 'upperLimit': '7.7'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '5.3', 'upperLimit': '7.7'}]}]}], 'paramType': 'MEDIAN', 'description': 'Only available for participants with analyzable data', 'unitOfMeasure': 'cells x10^9/l', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only collected for participants with AL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.'}, {'title': 'Total lymphocyte count at enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG000', 'lowerLimit': '1.7', 'upperLimit': '2.9'}, {'value': '2.3', 'groupId': 'BG002', 'lowerLimit': '1.7', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEDIAN', 'description': 'Only available for participants with analyzable data', 'unitOfMeasure': 'cells x10^9/l', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.'}, {'title': 'Lymphocyte subsets at enrollment', 'classes': [{'title': 'CD3+ T cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '1.9'}, {'value': '1.4', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '1.9'}]}]}, {'title': 'CD4+ T cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000', 'lowerLimit': '0.6', 'upperLimit': '1.0'}, {'value': '0.8', 'groupId': 'BG002', 'lowerLimit': '0.6', 'upperLimit': '1.0'}]}]}, {'title': 'CD8+ T cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'BG002', 'lowerLimit': '0.3', 'upperLimit': '0.7'}]}]}, {'title': 'NK cells (CD56+/CD16+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '0.2'}, {'value': '0.2', 'groupId': 'BG002', 'lowerLimit': '0.1', 'upperLimit': '0.2'}]}]}, {'title': 'CD19+ B cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '0.7'}, {'value': '0.6', 'groupId': 'BG002', 'lowerLimit': '0.4', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells x10^9/l', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.'}, {'title': 'Total serum IgG at enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'BG000', 'lowerLimit': '7.1', 'upperLimit': '11.1'}, {'value': '8.5', 'groupId': 'BG002', 'lowerLimit': '7.1', 'upperLimit': '11.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Only available for participants with analyzable data', 'unitOfMeasure': 'g/l', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Only collected for participants with ALL. Immunological markers not available on all participants with ALL, denominator reflects number of participants with analyzable values for each test.'}, {'title': 'Previous doses of PCV', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '1-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '≥3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Received more than ≥1 dose at ≥12 months of age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Received more than ≥1 dose PCV13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous doses of DTaP or Tdap', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': '1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': '4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': '≥5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous doses of varicella vaccine', 'classes': [{'title': '0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': '1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': '≥2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Interval from last vaccine to baseline blood draw', 'classes': [{'title': 'DTaP/Tdap-containing vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '4.85', 'spread': '2.6', 'groupId': 'BG002'}]}]}, {'title': 'PCV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '6.3', 'spread': '2.85', 'groupId': 'BG002'}]}]}, {'title': 'Varicella', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.5', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '5.85', 'spread': '3.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-14', 'size': 426470, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-06T07:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2015-05-13', 'resultsFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2015-05-14', 'lastUpdatePostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-17', 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability', 'timeFrame': 'days 8-10 and 30-33', 'description': 'Adverse Events Following Immunization requiring healthcare visit or leading to \\>=1 day of disability will be captured through structured telephone interviews on days 8-10 and 30-33 after each immunization'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23', 'timeFrame': 'Pre-vaccination Baseline, 2 months and 12-15 months', 'description': 'The percentage of participants with protective titres (with protective level defined as ≥0.35 ug/ml, as per World Health Organization criteria) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Protective Titres to PCV7 Serotypes at Baseline', 'timeFrame': 'Day 0', 'description': 'The number of participants with protective titres (≥0.35 ug/ml) to PCV7 serotypes at baseline will be compared to age-matched controls.'}, {'measure': 'Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (GMT) and percentage of subjects with protective titres to pneumococcal serotypes in children with ALL versus age-matched controls.'}, {'measure': 'Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination', 'timeFrame': 'Prevaccination baseline, 2 months, 12-15 months', 'description': 'Baseline, Short-term (baseline - 2 months after vaccination) and long-term (baseline - 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMT ratios.'}, {'measure': 'Baseline Tetanus Toxoid Antibody Titers in Children With ALL Versus Controls', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls'}, {'measure': 'Baseline Pertussis Toxin Titers in Children With ALL Versus Healthy Controls', 'timeFrame': 'Day 0', 'description': 'Baseline geometric mean titers (95% confidence intervals) reported as IU/ml in children with ALL versus controls'}, {'measure': 'Baseline Varicella Titers in Children With ALL Versus Controls.', 'timeFrame': 'Day 0', 'description': 'Geometric mean titers (95% confidence interval) in AI (antibody index)'}, {'measure': 'Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization', 'timeFrame': 'baseline, 2 months, 12-15 months', 'description': 'Baseline, short-term (baseline to 2 months after vaccination) and long-term (baseline to 12-15 months) vaccine responses to DTaP-IPV-Hib will be measured using GMTs with 95% confidence intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '32067048', 'type': 'DERIVED', 'citation': 'Top KA, Vaudry W, Morris SK, Pham-Huy A, Pernica JM, Tapiero B, Gantt S, Price VE, Rassekh SR, Sung L, McConnell A, Rubin E, Chawla R, Halperin SA. Waning Vaccine Immunity and Vaccination Responses in Children Treated for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study. Clin Infect Dis. 2020 Dec 3;71(9):e439-e448. doi: 10.1093/cid/ciaa163.'}]}, 'descriptionModule': {'briefSummary': 'This multi-center open label clinical trial aims to identify predictors of low antibody titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6 months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and 13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2 months later. The results will support the development of clinical practice guidelines for this population.', 'detailedDescription': 'Rationale and Aims: Children with acute lymphoblastic leukemia (ALL) have evidence of persistent immunosuppression following chemotherapy and may experience waning of immunity to vaccines received prior to treatment. There is no standard of care in Canada regarding immunologic evaluation or booster immunization of children with ALL after chemotherapy. This study aims to identify predictors of low baseline immunity to vaccine antigens in children with ALL and to evaluate the immunogenicity and safety of a standard immunization regimen: DTaP-IPV-Hib and PCV13 booster immunization administered 6 months post-chemotherapy, followed by PPV23.\n\nStudy Design: This will be a multi-center open-label clinical trial in which children who were diagnosed with ALL at ≥1 year of age, and have not received immunizations other than influenza since completing chemotherapy will undergo immunologic evaluation and serologic testing for pneumococcus, tetanus, pertussis and varicella. They will then be immunized with PCV13, DTaP-IPV-Hib, regardless of immunization history \\[unless PPV23 was received within the prior 12 months\\]. Other routine vaccines required as per provincial and centre-specific immunization policies will also be administered. PPV23 will be administered 8 weeks after PCV13. Repeat serologic testing will be conducted at 2 months and 12-15 months after DTaP-IPV-Hib and PCV13 immunization to assess short and long-term immune responses.\n\nAdverse events following immunization (AEFI) will be captured through standardized telephone interviews on days 8-10 and 30-33 post-immunization that will capture local and systemic AEFI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Cases with ALL:\n\nInclusion Criteria:\n\n* Diagnosed with standard, high-risk or very-high risk ALL\n* Age at diagnosis: ≥1 year of age (age at enrollment: ≥3 years)\n* Completed chemotherapy 3 to 12 months prior to enrollment\n* No evidence of ALL relapse or secondary malignancy\n* No known primary immunodeficiency\n* No receipt of pneumococcal or tetanus-containing vaccines since completing chemotherapy\n* No history of allergy to any component of PCV13\n* Caregiver and/or participant is English or French-speaking and able to provide written informed consent\n\nExclusion Criteria:\n\n* Infantile ALL\n* Evidence of disease relapse or secondary malignancy\n* History of underlying primary immunodeficiency\n* Transplant recipient\n* Received intravenous immunoglobulin (IVIG) within past 9 months or other blood products within the prior 3 months.Children who received PPV23 within 12 months of enrollment will not be eligible to receive PCV13 or PPV23. These children can still participate in the baseline evaluation, receive DTaP-Hib-IPV vaccine, and have tetanus and pertussis serology measured at 2 and 12-15 months post-immunization.\n\nControls:\n\nInclusion criteria\n\n* Children 3-18 years of age, age-matched to cases\n* Caregiver and/or participant is English or French-speaking and able to provide written informed consent\n\nExclusion criteria\n\n* History of primary or secondary immunodeficiency including aplastic anemia, malignancy, nephrotic syndrome, malabsorption or severe malnutrition\n* Immunosuppressive therapy within 3 months of enrollment (excluding inhaled corticosteroids)\n* Received intravenous immunoglobulin (IVIG) within past 9 months or other blood products within the prior 3 months.'}, 'identificationModule': {'nctId': 'NCT02447718', 'briefTitle': 'Vaccinating Children After Chemotherapy', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Immunization Research Network'}, 'officialTitle': 'Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study', 'orgStudyIdInfo': {'id': 'SI02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental', 'description': 'Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.', 'interventionNames': ['Biological: Prevnar®13', 'Biological: Pneumovax® 23', 'Biological: Pediacel®']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Control', 'description': 'Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.'}], 'interventions': [{'name': 'Prevnar®13', 'type': 'BIOLOGICAL', 'otherNames': ['13- valent conjugate pneumococcal vaccine', 'PCV13'], 'description': 'A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.', 'armGroupLabels': ['Experimental']}, {'name': 'Pneumovax® 23', 'type': 'BIOLOGICAL', 'otherNames': ['23-valent polysaccharide pneumococcal vaccine', 'PPV23'], 'description': 'A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13', 'armGroupLabels': ['Experimental']}, {'name': 'Pediacel®', 'type': 'BIOLOGICAL', 'otherNames': ['DTaP-IPV-Hib'], 'description': 'A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Karina Top, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Immunization Research Network', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karina Top', 'investigatorAffiliation': 'Canadian Immunization Research Network'}}}}