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Virus Therapy

RSVpreF for Respiratory Infections

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from birth up to 24 months of age
Awards & highlights

Study Summary

This trial will test if a RSV vaccine is safe and effective in pregnant women and their infants.

Eligible Conditions
  • Recurrent Respiratory Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth up to 24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and from birth up to 24 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination
Percentage of maternal participants reporting SAEs
Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7
+6 more
Secondary outcome measures
The percentage reduction in the incidence of MA-LRTI due to RSV in infants participants
The percentage reduction in the incidence of all-cause MA-LRTI in infant participants
The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSVpreF vaccineExperimental Treatment1 Intervention
RSVpreF
Group II: Placebo dosePlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVpreF
2023
Completed Phase 3
~17130

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,897,174 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,078,342 Total Patients Enrolled

Media Library

RSVpreF (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04424316 — Phase 3
Respiratory Infections Research Study Groups: RSVpreF vaccine, Placebo dose
Respiratory Infections Clinical Trial 2023: RSVpreF Highlights & Side Effects. Trial Name: NCT04424316 — Phase 3
RSVpreF (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04424316 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are Canadian hospitals collaborating to administer this trial?

"There are 100 sites enrolling patients in this trial. The locations nearest you are Gulfport, Nampa and Burleson along with other nearby locations. To minimize travel requirements, please select the clinic closest to your location."

Answered by AI

Would it be possible for me to join this clinical trial?

"This trial is for respiratory tract infections and the age limit has been set between 0 to 49 years old. So far, 14734 people have met the requirements and have signed up for the study."

Answered by AI

Has RSVpreF received regulatory approval from the FDA?

"We have rated the safety of RSVpreF as a 3. This is because it is a Phase 3 trial, which suggests that there is some evidence for its efficacy and that it has undergone multiple rounds of testing for safety."

Answered by AI

Could you tell me if the age limit for this research is 65 years old?

"In order to meet the requirements for this particular study, applicants must be between 0 and 49 years old. Out of the 104 total clinical trials, 41 are for individuals below 18 and 63 are dedicated to patients 65 or older."

Answered by AI

Are people still able to sign-up for this clinical trial?

"The clinicaltrials.gov website says that this trial is not recruiting patients at the moment. This research was originally posted on June 17th, 2020 and last updated on November 14th, 2020. Although this study isn't looking for volunteers presently, there are 94 other trials which are."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
How old are they?
18 - 65
What site did they apply to?
Jackson Heights Family Health Center
Ventavia Research Group LLC
Medical City Arlington (Women's Hospital)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
The Lancet Global HealthJournal
Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia
Ginsburg, Amy Sarah, and Padmini Srikantiah. 2021. “Respiratory Syncytial Virus: Promising Progress Against a Leading Cause of Pneumonia”. The Lancet Global Health. Elsevier BV. doi:10.1016/s2214-109x(21)00455-1.
clinicaltrials.govStudy
A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
2020. "A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04424316.
~3041 spots leftby Apr 2025
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