Trials / Completed
CompletedNCT04633226
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)
A Phase 3, Single-Arm, Open-label Clinical Study to Evaluate the Safety and Immunogenicity of 4 Doses of V114 Administered to Healthy Infants in South Korea.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 42 Days – 90 Days
- Healthy volunteers
- Accepted
Summary
The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | 15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL sterile suspension for intramuscular injection. |
Timeline
- Start date
- 2021-02-10
- Primary completion
- 2022-11-04
- Completion
- 2022-11-04
- First posted
- 2020-11-18
- Last updated
- 2024-09-24
- Results posted
- 2024-04-15
Locations
19 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04633226. Inclusion in this directory is not an endorsement.