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

ConditionRSV Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • RSVpreF

    Biological/Vaccine

    Single Dose

  • Placebo

    Biological/Vaccine

    Single Dose

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: RSVpreFExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of pregnant participants reporting local reactions

Pain at the injection site, redness, and swelling

Time frame
From Day 1 Through at least Day 7 after Vaccination
2

Percentage of pregnant participants reporting systemic events

Fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain

Time frame
From Day 1 Through at least Day 7 after Vaccination
3

Percentage of pregnant participants reporting adverse events

Time frame
From Day 1 through 4 weeks after vaccination
4

Percentage of pregnant participants reporting serious adverse events

Time frame
From Day 1 throughout the study

Secondary outcomes

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

Other outcomes

Sponsors and contacts

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