A study to investigate the reactogenicity, safety, and immunogenicity of mRNA-1345 in pregnant women, and safety and immunogenicity in their infants
- Conditions
- Respiratory syncytial virusTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-505359-37-00
- Lead Sponsor
- Moderna Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 360
Participants are eligible to be included in the study only if all of the following criteria apply: ?Maternal Participants Age 1. Are adults =18 years to <40 years of age inclusive, at the time of signing the informed consent., Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy., Japanese women specific: Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan., Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations., Informed Consent - Are willing and able (on both a physical and cognitive basis) to give written informed consent for themselves and their unborn child prior to study enrollment, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.* *Consent of the individual identified as the co-parent of the unborn child to be obtained in addition, if required by local regulations., Infant Participants Informed Consent - Have consent from infant participant’s parent(s)/LAR(s) if required by local regulations., Type of Participant and Disease Characteristics 2. Healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests, Will be 280/7 to 360/7 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report). Details of the method for determination of the gestational age will be provided in the Study Operational Manual., Intend to reside within a geographic area in which emergency pediatric care is provided by a study-affiliated site., Intend to deliver at a maternity unit where study procedures can be performed., Are willing and able to attend all study visits, to undergo all study procedures/or have their infant undergo all study procedures, and to comply with study requirements, including a means of communication (eg, phone, text message or email) with study site staff., Give permission for study site staff to access their/or their infant’s relevant medical information from other healthcare facilities should healthcare be sought at nonstudy facilities postenrollment.
Maternal Participants Weight - Body mass index of =40 kg/m2 at time of the Screening Visit., Have an infection with HIV, HBV, HCV, syphilis, or laboratory test results at the Screening Visit outside the normal reference value for pregnant women according to their trimester in pregnancy., Have conditions in the current pregnancy that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including but not limited to (refer to the Study Operational Manual for further details): a. Multiple pregnancies (eg, twins, triplets). b. Congenital malformation or clinically significant abnormalities on obstetric ultrasound. c. Congenital infection, including rubella, cytomegalovirus, toxoplasmosis, HSV (eg, primary genital HSV infection). d. Gestational hypertension, or preeclampsia. e. Antenatal hemorrhage. f. In-utero-growth restriction. g. Placental abnormality. h. Poly/oligohydramnios. i. Gestational diabetes. j. Pregnancy as a result of in vitro fertilization or other assisted reproductive technology. k. Threatened premature labor. l. Cervical insufficiency. m. Confirmed SARS-CoV-2 infection at any time during the pregnancy, Had conditions in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures, including but not limited to (refer to the Study Operational Manual for further details): a. Stillbirth. b. Multiple (=3) miscarriages. c. Cervical insufficiency. d. Grand multiparity (5 or greater previous pregnancies). e. Premature delivery (<34 weeks). f. Fetus or infant with known genetic disorder or congenital malformations. g. Preeclampsia. h. Gestational diabetes. i. Poly/oligohydramnios. j. D (Rhesus) sensitization., Prior/Concomitant Therapy - Received or plans to receive any mRNA vaccine or COVID-19 vaccine within 4 weeks before or after Day 1 and/or any other nonstudy vaccine within 2 weeks before or after Day 1, Received systemic immunosuppressants for >14 consecutive days in total within 180 days prior to the Screening Visit (for corticosteroids, =10 mg/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed., Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation., Received blood or plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt through delivery (excludes Rho[D)] immune globulin (eg, RhoGAM), which can be given at any time)., Prior/Concurrent Clinical Study Experience Participated in another clinical research study where participant has received a study intervention (drug/biologic/device) within 180 days before Day 1. Current or previous participation in another RSV investigational study is exclusionary., Other Exclusion Criteria Is a study site staff or first-degree relatives/partners of study site staff., Infant Participants. Is a child who has been placed under the control or protection of an agency, organization, institution, or entity by the courts, the government, or a government body acting in accordance with powers conferred on them by laws and regulation (eg, foster care). This does not include a child who is adopted or has an appointed LAR., Medical Conditions - Acutely ill or febrile (temperature =3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method