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New treatment option for RSV Infection
Official title A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
ClinicalTrials.gov ID: NCT06866405
What this study is testing
What is RSVpreF?
RSVpreF is an investigational medicine, being studied as a potential treatment for rsv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 and older. Healthy volunteers may be eligible.
You may be able to join if
- Pregnant Participants-Cohort 1 and Cohort 2 Key Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without...
- Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.
- Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.
- Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.
- Agrees to let their baby take part in the study and gives their permission.
You likely can't join if
- Received any approved or experimental RSV vaccine since their previous pregnancy.
- Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.
- History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar...
- Current pregnancy problems or issues at the time of giving consent.
- Previous pregnancy issues or problems at the time of giving consent.
- Women who are breastfeeding at the time of enrollment Infant Participants
See the full eligibility criteria
- Pregnant Participants-Cohort 1 and Cohort 2 Key Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate.
- Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.
- Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.
- Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.
- Agrees to let their baby take part in the study and gives their permission.
- Able to sign a consent form, agreeing to follow the rules and conditions of the study. Key
- Received any approved or experimental RSV vaccine since their previous pregnancy.
- Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.
- History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine.
- Current pregnancy problems or issues at the time of giving consent.
- Previous pregnancy issues or problems at the time of giving consent.
- Women who are breastfeeding at the time of enrollment Infant Participants
- Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.
- Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures. Nonpregnant Participants-Cohort 3 Key Inclusion Criteria
- Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study.
- Able to sign a consent form, agreeing to follow the rules and requirements of the study. Key Exclusion Criteria
- Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.
- Taking part in other studies with new drugs within 28 days before giving consent or during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- North Miami Beach, Florida, United States
- Panama City, Florida, United States
- Boise, Idaho, United States
- Idaho Falls, Idaho, United States
- Nampa, Idaho, United States
- Ames, Iowa, United States
- Kansas City, Kansas, United States
- Lafayette, Louisiana, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
- Gulfport, Mississippi, United States
- Great Falls, Montana, United States
- Kalispell, Montana, United States
- Missoula, Montana, United States
- Grand Island, Nebraska, United States
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States; North Miami Beach, Florida, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.