Trials / Completed
CompletedNCT02037984
Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)
A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 341 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 6 Weeks – 49 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to assess the safety, tolerability, and immunogenicity of 5 different formulations of V114 in healthy adults and infants. Adults only will be enrolled in Period 1 and infants only will be enrolled in Period 2; Period 1 will complete prior to the start of Period 2.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Prevnar 13® | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose. |
| BIOLOGICAL | V114 1x:1x:1x | V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA). |
| BIOLOGICAL | V114 2x:2x:2x | V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| BIOLOGICAL | V114 2x:1x:2x | V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| BIOLOGICAL | V114 1x:1x:2x | V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
| BIOLOGICAL | V114 0.5x:0.5x:2x | V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA. |
Timeline
- Start date
- 2014-01-28
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2014-01-16
- Last updated
- 2019-06-24
- Results posted
- 2019-04-30
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02037984. Inclusion in this directory is not an endorsement.