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Recruiting NCT06866405

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

Phase III Interventional RSV Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RSVpreF, Placebo.
Who it may be relevant to
Registry conditions: RSV Infection. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, South Africa, The Gambia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.

Overview

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.

Detailed description

This study will include pregnant participants and their unborn babies (Cohort 1 and Cohort 2) and non-pregnant participants (Cohort 3), as described below:

* Cohort 1- Pregnant participants who had previously received RSVpreF as part of a Pfizer clinical trial and have antibody data available from that trial will get a second dose of RSVpreF. * Cohort 2- Pregnant participants who received the RSVpreF in a previous pregnancy, either through commercial means with Abrysvo® or as part of a Pfizer clinical trial, will be randomly chosen to get either one dose of the RSVpreF or one dose of a placebo. This applies to those who do not have antibody data available from the earlier trial.

For both groups of pregnant participants, the study will look at how safe and well-tolerated the vaccine is during pregnancy, as well as how the body responds to it.

Infants will be monitored for six months after birth to check safety and antibodies level.

• Cohort 3- Nonpregnant participants who received RSVpreF during a previous pregnancy as part of an earlier clinical trial will have blood samples taken to see how well their immune response has persisted over time. Participants will not receive any vaccine.

Interventions

  • Biological RSVpreF
    Single Dose
  • Biological Placebo
    Single Dose

Primary outcome measures

  • Percentage of pregnant participants reporting local reactions [Time frame: From Day 1 Through at least Day 7 after Vaccination]
  • Percentage of pregnant participants reporting systemic events [Time frame: From Day 1 Through at least Day 7 after Vaccination]
  • Percentage of pregnant participants reporting adverse events [Time frame: From Day 1 through 4 weeks after vaccination]
  • Percentage of pregnant participants reporting serious adverse events [Time frame: From Day 1 throughout the study]
  • In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting adverse events. [Time frame: From birth through 1 month of age]
  • In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting serious adverse events and newly diagnosed medical conditions. [Time frame: From birth through 6 months of age.]
  • Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth [Time frame: At birth]
Secondary outcome measures (1)
  • Proportion of participants achieving neutralizing antibody to RSV A and RSV B at 3 months and 6 months [Time frame: At 3 months and 6 months]

Eligibility criteria

Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria

  • 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.

Exclusion criteria

  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 81 centers
  • Center for Research in Women's Health — Birmingham
  • Children's of Alabama — Birmingham
  • University of Alabama at Birmingham - School of Medicine — Birmingham
  • University of Alabama at Birmingham Women & Infants Center — Birmingham
  • USA Health Children's and Women's Hospital — Mobile
  • USA Health Strada Patient Care Center — Mobile
  • Ronald Reagan UCLA Medical Center — Los Angeles
  • Ronald Reagan UCLA Medical Center (inpatient hospital) — Los Angeles
  • … and 73 more centers
South Africa · 8 centers

Center list to be confirmed — check the primary protocol.

Argentina · 7 centers

Center list to be confirmed — check the primary protocol.

The Gambia · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06866405 · C3671059 · C3671059-OPENLABEL; Marguerite

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗