CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 151 enrolled
Drug / intervention
Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04258995
NCT04258995Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Feb 6, 2020·Updated Oct 13, 2021

In Brief

A Phase 2 clinical trial evaluating Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6) for Group B Streptococcal Infections. Completed, enrolled 151 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcal Infections
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedFeb 6, 2020
Enrollment StartFeb 11, 2020
Primary CompletionSep 15, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.4 years ago

Interventions

Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)biological

2 formulations at 1 dose level