NCT03170609

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 365 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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).

Conditions

• Group B Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent group B streptococcus vaccine	Various formulations at three dose levels
BIOLOGICAL	Placebo	Saline Control

Timeline

• Start date: 2017-06-05
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2017-05-31
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study