CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 713 enrolled
Drug / intervention
RSV Vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04071158
NCT04071158Phase 2Completed
CompareCT.gov

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

Pfizer·interventional·Posted Aug 28, 2019·Updated Feb 15, 2021

In Brief

A Phase 2 clinical trial evaluating RSV Vaccine, Tdap, and 1 other intervention for Respiratory Tract Infection. Completed, enrolled 713 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Tract Infection
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartOct 1, 2019
Primary CompletionDec 11, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.8 years ago

Interventions

RSV Vaccinebiological

RSV vaccine

Tdapbiological

Tetanus, Diphtheria, and Acellular Pertussis Vaccine

Placebobiological

Normal saline solution for injection (0.9% sodium chloride injection)