RSVpreF for Respiratory Tract Infections

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Respiratory Tract Infections+1 More
RSVpreF - Biological
Eligibility
< 65
Female
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Respiratory Tract Infections

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Respiratory Tract Infections

Study Objectives

9 Primary · 3 Secondary · Reporting Duration: From birth up to 24 months of age

Birth
The percentage of infant participants with specific birth outcomes
Day 180
The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life
The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of life
Day 360
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
Month 12
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of age
Month 24
The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of age
Day 7
Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7
Day 180
Percentage of maternal participants reporting SAEs
Month 1
The percentage of infant participants with adverse events (AEs) from birth to 1 month of age
Month 1
Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Respiratory Tract Infections

Trial Design

2 Treatment Groups

RSVpreF vaccine
1 of 2
Placebo dose
1 of 2
Experimental Treatment
Non-Treatment Group

14735 Total Participants · 2 Treatment Groups

Primary Treatment: RSVpreF · Has Placebo Group · Phase 3

RSVpreF vaccine
Biological
Experimental Group · 1 Intervention: RSVpreF · Intervention Types: Biological
Placebo dose
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from birth up to 24 months of age

Who is running the clinical trial?

PfizerLead Sponsor
4,260 Previous Clinical Trials
7,090,230 Total Patients Enrolled
12 Trials studying Respiratory Tract Infections
56,613 Patients Enrolled for Respiratory Tract Infections
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,248 Previous Clinical Trials
4,805,910 Total Patients Enrolled
11 Trials studying Respiratory Tract Infections
4,862 Patients Enrolled for Respiratory Tract Infections

Eligibility Criteria

Age < 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The woman had negative HIV, syphilis, and HBV tests during her pregnancy and before she was chosen for the study.
The subject is expected to be available for the entire study and can be contacted by telephone if needed.
The participant is willing to allow her infant to participate in the study and has given informed consent.
They selected participants for the study by looking at their medical history, doing a physical examination, and using their clinical judgement.
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 protocol
Women who are healthy, aged ≤49 years, and in the 24- to 36-week period of their pregnancy can get the vaccine without risk.
Can comply with the study schedule, which includes visits, treatments, lab tests, etc.
Prenatal care is based on the requirements of the country you live in.
The patient had a fetal anomaly ultrasound examination performed at 18 weeks of pregnancy and no significant fetal abnormalities were observed.
Our hospital is where the study procedures will be carried out.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: October 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas66.7%
New York33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Jackson Heights Family Health Center50.0%
Ventavia Research Group LLC50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%

How responsive is this trial?

Typically responds via
Email100.0%