Clinical Trials Directory

Trials / Completed

CompletedNCT04071158

A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS

A PHASE 2b, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) 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
713 (actual)
Sponsor
Pfizer · Industry
Sex
Female
Age
18 Years – 49 Years
Healthy volunteers
Accepted

Summary

This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.

Detailed description

This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. The participants will be equally split into 5 treatment groups: One of a possible two dose levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination. This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine candidate and vice-versa by measuring participants' immune response through appropriate antibody and component levels 1 month after vaccination.

Conditions

Interventions

TypeNameDescription
BIOLOGICALRSV VaccineRSV vaccine
BIOLOGICALTdapTetanus, Diphtheria, and Acellular Pertussis Vaccine
BIOLOGICALPlaceboNormal saline solution for injection (0.9% sodium chloride injection)

Timeline

Start date
2019-10-01
Primary completion
2019-12-11
Completion
2019-12-11
First posted
2019-08-28
Last updated
2021-02-15
Results posted
2021-02-15

Locations

16 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04071158. Inclusion in this directory is not an endorsement.