protocolSection identificationModule nctId: NCT06325657, orgStudyIdInfo id: C3671032, briefTitle: A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants, acronym: MORISOT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-06-11, completionDateStruct date: 2025-06-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Respiratory Syncytial Virus, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: This is a double-blinded, placebo-controlled study, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 330, type: ESTIMATED, armsInterventionsModule interventions name: RSVpreF vaccine, interventions name: Placebp, outcomesModule primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting systemic reactions, primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting local reactions, primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs), primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Adverse Event of Special Interests (AESIs), primaryOutcomes measure: Maternal Participants Primary Safety - The proportion of participants reporting Serious Adverse Events (SAEs), primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Specific Birth Outcomes, primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting Adverse Events (AEs), primaryOutcomes measure: Infant Participants Primary Safety - The proportion of participants reporting SAEs and Newly Diagnosed Chronic Medical Conditions (NDCMCs), secondaryOutcomes measure: Maternal Participants: Secondary Immunogenicity - GMT of NTs for RSV A and RSV B, secondaryOutcomes measure: Maternal Participants: Secondary Immunogenicity - GMFR of NTs for RSV A and RSV B, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 49 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Synergy Biomed Research Institute, status: NOT_YET_RECRUITING, city: East London, state: Eastern CAPE, zip: 5241, country: South Africa, geoPoint lat: -33.01529, lon: 27.91162, locations facility: Josha Research, status: NOT_YET_RECRUITING, city: Bloemfontein, state: FREE State, zip: 9301, country: South Africa, geoPoint lat: -29.12107, lon: 26.214, locations facility: Worthwhile Clinical Trials, status: RECRUITING, city: Benoni, state: Gauteng, zip: 1500, country: South Africa, geoPoint lat: -26.18848, lon: 28.32078, locations facility: REIMED Reiger Park, status: NOT_YET_RECRUITING, city: Boksburg, state: Gauteng, zip: 1459, country: South Africa, geoPoint lat: -26.21197, lon: 28.25958, locations facility: Wits RHI, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2001, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA), status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2013, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Wits VIDA Nkanyezi Research Unit, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2093, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Wits VIDA Nkanyezi, status: NOT_YET_RECRUITING, city: Johannesburg, state: Gauteng, zip: 2093, country: South Africa, geoPoint lat: -26.20227, lon: 28.04363, locations facility: Botho Ke Bontle Health Services, status: RECRUITING, city: Pretoria, state: Gauteng, zip: 0184, country: South Africa, geoPoint lat: -25.74486, lon: 28.18783, locations facility: Setshaba Research Centre, status: NOT_YET_RECRUITING, city: Tshwane, state: Gauteng, zip: 0152, country: South Africa, locations facility: Qhakaza Mbokodo Research Clinic, status: NOT_YET_RECRUITING, city: Ladysmith, state: Kwazulu-natal, zip: 3370, country: South Africa, geoPoint lat: -28.55874, lon: 29.77896, locations facility: Gole Biomed Research Centre, status: RECRUITING, city: Polokwane, state: Limpopo, zip: 0734, country: South Africa, geoPoint lat: -23.90449, lon: 29.46885, locations facility: MRC Unit on Child And Adolescent Health, status: NOT_YET_RECRUITING, city: Cape Town, state: Western CAPE, zip: 7700, country: South Africa, geoPoint lat: -33.92584, lon: 18.42322, hasResults: False