Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-01 @ 2:44 AM
Study NCT ID:
NCT06866405
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinding only applies to Cohort 2 of the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of pregnant participants reporting local reactions', 'timeFrame': 'From Day 1 Through at least Day 7 after Vaccination', 'description': 'Pain at the injection site, redness, and swelling'}, {'measure': 'Percentage of pregnant participants reporting systemic events', 'timeFrame': 'From Day 1 Through at least Day 7 after Vaccination', 'description': 'Fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain'}, {'measure': 'Percentage of pregnant participants reporting adverse events', 'timeFrame': 'From Day 1 through 4 weeks after vaccination'}, {'measure': 'Percentage of pregnant participants reporting serious adverse events', 'timeFrame': 'From Day 1 throughout the study'}, {'measure': 'In infant participants born to pregnant participants receiving a second dose of the study intervention, the percentage of participants reporting adverse events.', 'timeFrame': 'From birth through 1 month of age'}, {'measure': '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.', 'timeFrame': 'From birth through 6 months of age.'}, {'measure': 'Proportion of participants achieving neutralizing antibody to RSV A and RSV B at birth', 'timeFrame': 'At birth'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving neutralizing antibody to RSV A and RSV B at 3 months and 6 months', 'timeFrame': 'At 3 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'RSV vaccine', 'RSV', 'Maternal immunization'], 'conditions': ['RSV Infection']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3671059', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study will include pregnant participants and their unborn babies (Cohort 1 and Cohort 2) and non-pregnant participants (Cohort 3), as described below:\n\n* 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.\n* 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.\n\nFor 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.\n\nInfants will be monitored for six months after birth to check safety and antibodies level.\n\n• 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria\n\n* 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.\n* Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.\n* Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.\n* Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.\n* Agrees to let their baby take part in the study and gives their permission.\n* Able to sign a consent form, agreeing to follow the rules and conditions of the study.\n\nKey Exclusion Criteria\n\n* Received any approved or experimental RSV vaccine since their previous pregnancy.\n* Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.\n* 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.\n* Current pregnancy problems or issues at the time of giving consent.\n* Previous pregnancy issues or problems at the time of giving consent.\n\nInfant Participants\n\n* Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.\n* Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures.\n\nNonpregnant Participants-Cohort 3 Key Inclusion Criteria\n\n* 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.\n* Able to sign a consent form, agreeing to follow the rules and requirements of the study.\n\nKey Exclusion Criteria\n\n* Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.\n* Taking part in other studies with new drugs within 28 days before giving consent or during the study period."}, 'identificationModule': {'nctId': 'NCT06866405', 'briefTitle': 'A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'C3671059'}, 'secondaryIdInfos': [{'id': 'Marguerite', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RSVpreF', 'interventionNames': ['Biological: RSVpreF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'RSVpreF', 'type': 'BIOLOGICAL', 'description': 'Single Dose', 'armGroupLabels': ['RSVpreF']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Single Dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Center for Research in Women's Health", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - School of Medicine', 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'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA (outpatient clinic)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Clinical and Translational Research Center (research clinic)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital-Labor and Delivery Unit", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford Obstetrics Clinic', 'geoPoint': 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