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Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults

NCT04785612 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-07

Study results available
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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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

BIOLOGICAL

RSVPreF

A single dose of 120 mcg RSVpreF for intramuscular injection

OTHER

Placebo

A single Placebo dose for intramuscular injection to match experimental vaccine

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hvivo

    lead INDUSTRY

Principal Investigators

  • Alex Mann · Hvivo

  • Golam Kabir, MD · Hvivo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2021-04-08
Completion
2021-08-16

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT04785612 on ClinicalTrials.gov