Trials / Completed
CompletedNCT04031846
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
A Phase 3, Multicenter, Randomized, Double-blind, Active-comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,184 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 42 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rotarix™ | Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2) |
| DRUG | Infanrix™ hexa | Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13) |
| DRUG | V114 | 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 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 intramuscular administration, |
| DRUG | Prevenar 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 intramuscular administration. |
Timeline
- Start date
- 2019-09-04
- Primary completion
- 2021-08-05
- Completion
- 2021-08-05
- First posted
- 2019-07-24
- Last updated
- 2023-07-28
- Results posted
- 2023-05-03
Locations
60 sites across 9 countries: Australia, Belgium, Czechia, Estonia, Germany, Greece, Poland, Russia, Spain
Source: ClinicalTrials.gov record NCT04031846. Inclusion in this directory is not an endorsement.