Trial · NCT03537508
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Per-Protocol Analysis Set 3 (PPAS3) (for 2nd year of life vaccination). PPAS3 included participants of Full Analysis set 3 (FAS3: a subset of all randomized participants who received \>=1 dose of the study vaccine in the 2nd year of life \[\>=12 months of age\] and had a valid post-vaccination serology result in the 2nd year of life) with no relevant protocol deviations. Only those participants with data collected for each specific serogroup are reported. | percentage of participants | NUMBER |
| PRIMARY | Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | PPAS1 (for infant vaccination). PPAS1 included participants of FAS1 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[\<12 months of age\] and had a valid post-vaccination serology result in infancy) with no relevant protocol deviations during infancy. Only those participants with data collected for each specific serogroup are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected are reported. | Units/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified category are reported. | ELISA units/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination | Day 30 post 6-month vaccination (Month 7) | Analysis was performed on PPAS1 (for infant vaccination) which included participants of FAS1 with no relevant protocol deviations during infancy. Only those participants with data collected for each specified serotype are reported. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination | Day 30 post 12-month vaccination (Month 13) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified serotype are reported. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination | Day 30 post 15-month vaccination (Month 16) | Analysis was performed on PPAS3 (for 2nd year of life vaccination) which included participants of FAS3 with no relevant protocol deviations. Only those participants with data collected for each specified category are reported. | percentage of participants | NUMBER |
| SECONDARY | Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) | Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination and 4th dose is 12-month vaccination. | titer | GEOMETRIC_MEAN |
| SECONDARY | Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination | Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12) | Analysis was performed on PPAS2 (for immunogenicity persistence evaluation). Only those participants with data collected for each specified category are reported. 3rd dose is 6-month vaccination, 4th dose is 12-month vaccination. D0 is Day 0 and D30 is Day 30. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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