Trials / Completed
CompletedNCT03828617
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF 3 LOTS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS 18 THROUGH 49 YEARS OF AGE
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,710 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 49 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 20vPnC | 20vPnC |
| BIOLOGICAL | 20vPnC | 20vPnC |
| BIOLOGICAL | 20vPnC | 20vPnC |
| BIOLOGICAL | 13vPnC | Pneumococcal conjugate vaccine |
Timeline
- Start date
- 2019-02-14
- Primary completion
- 2019-10-09
- Completion
- 2019-10-09
- First posted
- 2019-02-04
- Last updated
- 2020-11-23
- Results posted
- 2020-11-04
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03828617. Inclusion in this directory is not an endorsement.