Full name
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
NCT Number
NCT03621670
Geography
US
Locations
Puerto Rico, United States
Primary Endpoints
- Percentages of subjects with solicited local (administration site event) and systemic Adverse Events (AEs). During the 7-day follow-up period after the 1st vaccination
- Percentages of subjects with solicited local (administration site event) and systemic AEs. During the 7-day follow-up period after the 2nd vaccination
- Percentages of subjects with solicited local (administration site event) and systemic AEs. During the 7-day follow-up period after the 3rd vaccination
- Percentages of subjects with solicited local (administration site event) and systemic AEs.During the 7-day follow-up period after the 4th vaccination
- Percentages of subjects with solicited systemic AEs. During the 30-day (Day 1 - Day 30) follow-up period after the 4th vaccination
- Percentages of subjects with all unsolicited AEs. During the 30-day follow-up period after the 1st vaccination
- Percentages of subjects with all unsolicited AEs. During the 30-day follow-up period after the 2nd vaccination
- Percentages of subjects with all unsolicited AEs. During the 30-day follow-up period after the 3rd vaccination
- Percentages of subjects with all unsolicited AEs. During the 30-day follow-up period after the 4th vaccination
- Percentages of subjects with SAEs, AEs leading to withdrawal, AESIs and medically attended AEs. Throughout the study period [Day 1 up to study end (Day 481 or Day 661)]
- Percentages of subjects with human serum bactericidal assay (hSBA) antibody titers ≥ Lower Limit of Quantitation (LLOQ) for each of the M14459, 96217, NZ98/254 and M13520 test strains. At 1 month after the 3rd vaccination (Day 151)
- Percentages of subjects with hSBA antibody titers ≥LLOQ for all strains combined (M14459, 96217, NZ98/254 and M13520). At 1 month after the 3rd vaccination (Day 151)
- Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for each of the test strains. At 1 month after the 4th vaccination (Day 331)
- Percentages of subjects with hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) for all strains combined (composite endpoint). At 1 month after the 4th vaccination (Day 331)
- Antibody Geometric Mean Concentrations (GMC) using electrochemiluminescence (ECL) assay for each of the 13 PCV13 antigens. At 1 month after the 3rd vaccination (Day 151)
External Link
https://clinicaltrials.gov/study/NCT03621670
Order
1
Disease
Version
Phase
3