Trials / Completed
CompletedNCT04258995
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
A PHASE 2, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 20 Years – 51 Years
- Healthy volunteers
- Accepted
Summary
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) | 2 formulations at 1 dose level |
Timeline
- Start date
- 2020-02-11
- Primary completion
- 2020-09-15
- Completion
- 2020-09-15
- First posted
- 2020-02-06
- Last updated
- 2021-10-13
- Results posted
- 2021-10-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04258995. Inclusion in this directory is not an endorsement.