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A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants

NCT06325657 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 648

Last updated 2025-07-14

No results posted yet for this study

Summary

The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.

The study will look at the safety, tolerability, and immune activity in mothers and their infants.

This study is seeking pregnant women who are:

* Less than or equal to 49 years old and have HIV (Human immunodeficiency virus -
* Receiving standard medical care during the pregnancy
* Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection).
* Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days.
* agree to be present for all study visits, procedures, and blood draws.

Participants will either receive:

* RSVpreF vaccine
* A placebo. A placebo does not have any medicine it but looks just like the study vaccine.

Pregnant participants will be involved in the study from:

* consent during their current pregnancy, and
* for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.

Conditions

Interventions

BIOLOGICAL

RSVpreF vaccine

RSVpreF vaccine

BIOLOGICAL

Placebp

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2025-06-11
Completion
2025-06-11
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06325657 on ClinicalTrials.gov