NCT04766086

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

Conditions

• Group B Streptococcus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Multivalent Group B streptococcus vaccine	Multivalent Group B streptococcus vaccine
BIOLOGICAL	Tetanus, diphtheria, and acellular pertussis vaccine	Tetanus, diphtheria, and acellular pertussis vaccine
BIOLOGICAL	Placebo	Saline control

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-04-27
• Completion: 2023-04-27
• First posted: 2021-02-23
• Last updated: 2024-05-24
• Results posted: 2024-05-24

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study