Search > Respiratory Syncytial Virus
My employer runs this trial

RSVpreF for Respiratory Syncytial Virus

Not yet recruiting at 1 trial location
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to \<18 years of age at high risk for RSV disease, including those who are immunocompromised.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for children ages 5 to under 18 who are at high risk of getting seriously ill from RSV, including those with weakened immune systems.

Inclusion Criteria

Participants considered by the investigator to be at high risk of LRTI-RSV based on disease characteristics and definitions
Chronic medical conditions include cystic fibrosis, medically treated asthma, other chronic respiratory diseases and malformations of the lung, trisomy 21 (Down syndrome), neuromuscular disease, cerebral palsy, hemodynamically significant or symptomatic congenital heart disease, sickle cell disease, confirmed stable HIV disease with viral load <50 copies/mL and CD4 count >200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral therapy for at least 6 months
Participants' weight requirements: Cohort 1a ≥30.0 kg, Cohort 1b ≥14.5 kg, Cohort 2a ≥30 kg, Cohort 2b ≥14.5 kg at enrollment
See 6 more

Exclusion Criteria

Applicable to Cohort 1 (a and b) only: Immunocompromised individuals with known or suspected immunodeficiency by history or examination
Applicable to Cohort 1 (a and b) only: History of autoimmune disease requiring therapeutic intervention, excluding stable type 1 diabetes and hypothyroidism
History of severe adverse reaction or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • RSVpreF

Trial Overview

The study is testing an RSV vaccine called RSVpreF compared to a placebo (inactive shot) in high-risk children. The goal is to see if the vaccine is safe and helps their bodies build protection against RSV.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 2: RSVpreF/RSVpreFExperimental Treatment1 Intervention
Group II: Cohort 2: RSVpreF/PlaceboExperimental Treatment2 Interventions
Group III: Cohort 1: RSVpreFExperimental Treatment1 Intervention
Group IV: Cohort 1: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.