Trial · NCT03537508
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place. |
| 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) | Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place. |
| 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) | Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer \>=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place. |
| 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) | Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer \>=0.15 mcg/mL and \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place. |
| 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) | Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 were assessed. |
| 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) | Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations \>=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place. |
| 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) | GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA. |
| 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) | GMCs of anti-pertussis antibodies (pertussis toxoid \[PT\], filamentous hemagglutinin adhesin \[FHA\], pertactin \[PRN\] and fimbriae types 2 and 3 \[FIM\]) were measured by electrochemiluminescent (ECL) assay. |
| 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) | GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibodies in human serum. |
| 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) | Vaccine response against anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay and anti-mumps antibodies were assessed by ELISA. Percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion are reported: measles: \>=255 mIU/mL; mumps: \>=10 antibody units per milliliter and rubella: \>=10 IU/mL. Percentages are rounded off to the tenth decimal place. |
| 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) | Vaccine response against anti-varicella antibodies were measured by glycoprotein (gp) ELISA. Percentage of participants with anti-varicella antibody concentration \>=5 antibody (Ab) gpELISA units/mL are reported. Percentages are rounded off to the tenth decimal place. |
| 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) | GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which is used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) antibodies in human serum. |
| 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) | Anti-PRP concentrations were measured using a farr-type RIA. The percentage of participants with an PRP antibody titers \>=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place. |
| 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) | Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers \>=1:8 are assessed. |
| 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) | Vaccine response was defined as: if the pre-booster (4th) vaccination concentration was \<lower limit of quantification (LLOQ), then the post-booster (4th) vaccination concentration should be \>=4 times LLOQ. The LLOQ was equal to 2.00 EU/mL. Percentages are rounded off to the tenth decimal place. |
| 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) | GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. PPAS2 included participants of FAS2 (subset of all randomized participants who received \>=1 dose of the study vaccine in infancy \[at Visit 1 to 3, \< 12 months of age\] and had a valid pre-vaccination serology result at Visit 5 before the 12-month vaccinations for Subgroups 1a and 2a or at Visit 6 before the 15-month vaccinations for Subgroups 1b and 2b) with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. |
| 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) | Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. PPAS2 included participants of FAS2 with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. Percentages are rounded off to the tenth decimal place. |
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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