CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
RSVPreF +1 morebiological
Likely dose
RSVPreF 120 mcgfrom 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/NCT04785612
NCT04785612Phase 2Completed

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity and Efficacy of A Respiratory Syncytial Virus Vaccine (RSVpreF) in A Virus Challenge Model in Healthy Adults

Hvivo·interventional·Posted Mar 8, 2021·Updated Aug 7, 2024

In Brief

A Phase 2 clinical trial evaluating RSVPreF and Placebo for Respiratory Syncytial Virus Infections. Completed, enrolled 70 participants across 1 site.

Detailed Summary

In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and challenged with RSV one month later. The purpose of this research study is to assess the safety, immunogenicity and efficacy of RSVpreF using a human viral challenge model.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 8, 2021
Enrollment StartNov 10, 2020
Primary CompletionApr 8, 2021
Study CompletionAug 16, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.3 years ago

Interventions

RSVPreFbiological

A single dose of 120 mcg RSVpreF for intramuscular injection

Placeboother

A single Placebo dose for intramuscular injection to match experimental vaccine