Trials / Completed
CompletedNCT03615482
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU)
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (PNEU-FLU)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
This study was designed to evaluate the safety and tolerability of a single dose of V114 when administered concomitantly and non-concomitantly (i.e., 30 days after) with influenza vaccine. It also evaluated whether V114 can be administered concomitantly with influenza vaccine without impairing the antibody response to the 15 serotypes contained in V114 and to the 4 influenza viruses contained in the seasonal inactivated quadrivalent influenza vaccine (QIV). The primary hypotheses state that immune responses to V114 and to QIV are non-inferior when administered concomitantly as compared with non-concomitant administration as measured by serotype-specific opsonophagocytic activity (OPA) and hemagglutination inhibition (HAI) geometric mean titers (GMTs) at 30 days postvaccination. This study will also contribute to the overall safety database and immunogenicity data for V114 to support initial licensure in adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | V114 | Single 0.5 mL injection |
| BIOLOGICAL | QIV | Single 0.5 mL injection |
| BIOLOGICAL | Matching Placebo for V114 | Single 0.5 mL injection |
Timeline
- Start date
- 2018-09-14
- Primary completion
- 2019-06-24
- Completion
- 2019-06-24
- First posted
- 2018-08-03
- Last updated
- 2024-05-22
- Results posted
- 2020-06-29
Locations
45 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03615482. Inclusion in this directory is not an endorsement.