Trials / Completed
CompletedNCT03848065
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
A Phase I, Double-Blind, Randomized, Multicenter Trial of the Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 133 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 3 Months – 3 Months
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose. |
| BIOLOGICAL | Pneumococcal 13-valent Conjugate Vaccine (PCV13) | 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose. |
| BIOLOGICAL | Adsorbed Diphtheria-purified Pertussis-tetanus-inactivated polio (Sabin strain) Combined Vaccine (DTaP-IPV) | Single SC dose of 0.5 mL at Visits 1, 2, 3 and 5 (approximately 3, 4, 5, and 12 to 15 months of age). |
Timeline
- Start date
- 2019-04-02
- Primary completion
- 2020-06-24
- Completion
- 2020-06-24
- First posted
- 2019-02-20
- Last updated
- 2025-01-15
- Results posted
- 2023-10-11
Locations
14 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03848065. Inclusion in this directory is not an endorsement.