CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 365 enrolled
Drug / intervention
Multivalent group B streptococcus vaccine +1 morebiological
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/NCT03170609
NCT03170609Phase 2Completed
CompareCT.gov

A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY ADULTS 18 TO 49 YEARS OF AGE

Pfizer·interventional·Posted May 31, 2017·Updated Jul 2, 2019

In Brief

A Phase 2 clinical trial evaluating Multivalent group B streptococcus vaccine and Placebo for Group B Streptococcal Infections. Completed, enrolled 365 participants across 4 sites.

Detailed Summary

This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 31, 2017
Enrollment StartJun 5, 2017
Primary CompletionJun 25, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.1 years ago

Interventions

Multivalent group B streptococcus vaccinebiological

Various formulations at three dose levels

Placebobiological

Saline Control