Trials / Completed
CompletedNCT03885934
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 606 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 7 Months – 17 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration |
| BIOLOGICAL | Prevnar 13® | Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration. |
Timeline
- Start date
- 2019-06-25
- Primary completion
- 2020-12-09
- Completion
- 2020-12-09
- First posted
- 2019-03-22
- Last updated
- 2023-01-13
- Results posted
- 2021-09-23
Locations
26 sites across 5 countries: Finland, Malaysia, Poland, Russia, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03885934. Inclusion in this directory is not an endorsement.