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

NCT04766086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-05-24

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-12
Primary Completion
2023-04-27
Completion
2023-04-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766086 on ClinicalTrials.gov