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

Group B Streptococcal Infections Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03170609
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 2
Start date	June 5, 2017
Completion date	June 25, 2018

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See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05782179` - Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants	Phase 1
Completed	`NCT04258995` - 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	Phase 2
Recruiting	`NCT05726006` - Invasive Group B Streptococcus Disease Burden and Its Antimicrobial Resistance in Malaysia Among Non-pregnant Adults.