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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
4,587 Previous Clinical Trials
14,623,163 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,491 Previous Clinical Trials
11,799,915 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
~2940 spots leftby Jun 2025