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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from birth up to 24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from birth up to 24 months of age
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 moreSecondary 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
4,595 Previous Clinical Trials
12,854,071 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,030,680 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The participant is willing to allow her infant to participate in the study and has given informed consent.The woman had negative HIV, syphilis, and HBV tests during her pregnancy and before she was chosen for the study.Women who are pregnant with only one baby, are younger than 49 years old, and are between 24 and 36 weeks pregnant. They should also not have any known complications that could increase the risk of problems.You plan to give birth at a hospital or facility where the study can be carried out.A detailed ultrasound exam was done during the second trimester of pregnancy, and no significant problems were found with the baby.Based on your medical history, physical examination, and doctor's decision, you are a suitable candidate for this study.Can comply with the study schedule, which includes visits, treatments, lab tests, etc.The participant must be capable of understanding and signing an informed consent form, which includes understanding the requirements and restrictions listed in the form and in the study protocolYou must be available throughout the study and reachable by phone.You are pregnant and receiving the standard medical care required by your country.
Research Study Groups:
This trial has the following groups:- Group 1: RSVpreF vaccine
- Group 2: Placebo dose
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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