A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus in Pregnant Women and in Infants Born to Vaccinated Mothers
- Conditions
- Respiratory Syncytial Virus
- Interventions
- Biological: Placebo
- Registration Number
- NCT06143046
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The purpose of the study is to evaluate the reactogenicity, safety, and immunogenicity of an investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345, in pregnant women, and safety and immunogenicity in infants born to vaccinated mothers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 360
Maternal Participants
- Are adults ≥18 years to <40 years of age inclusive, at the time of signing the informed consent.
- Will be 28 to 36 weeks pregnant at the time of vaccination (confirmed by an obstetric ultrasound report).
- 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 (for example, phone, text message or email) with study site staff.
- Have engaged with local antenatal care and will continue to do so through the remainder of their pregnancy.
- Have had an antenatal obstetric ultrasound at ≥18 weeks of pregnancy or be willing to have an antenatal obstetric ultrasound at Screening if not already conducted.
Specific inclusion criteria for Japanese pregnant women:
- Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan.
Infant Participants
- Have consent from infant participant's parent(s)/legally authorized representative (LAR) if required by local regulations.
Key
Maternal Participants
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius [℃]/100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine or therapeutic or any components of an mRNA-1345 vaccine.
- Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
- Have conditions in the current pregnancy or in previous pregnancies that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- 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.
- Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
- Intend for their infant to receive RSV monoclonal antibodies after delivery.
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 (for example, foster care). This does not include a child who is adopted or has an appointed LAR.
Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mRNA-1345 Dose B mRNA-1345 Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B. mRNA-1345 Dose C mRNA-1345 Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C. Placebo Placebo Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation. mRNA-1345 Dose A mRNA-1345 Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.
- Primary Outcome Measures
Name Time Method Number of Infant Participants with MAAEs Day 1 (birth) to Month 12 Number of Maternal Participants with Adverse Events of Special Interest (AESIs) Day 1 to Month 12 (12 months postdelivery) Number of Maternal Participants with Serious Adverse Events (SAEs) Day 1 to Month 12 (12 months postdelivery) Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 7 (7 days post vaccination) Number of Infant Participants with AESIs Day 1 (birth) to Month 12 Number of Infant Participants with SAEs Day 1 (birth) to Month 12 Number of Maternal Participants with Unsolicited Adverse Events (AEs) Up to Day 28 (28 days post vaccination) Number of Maternal Participants with Medically-Attended AEs (MAAEs) Day 1 to Month 6 (6 months postdelivery) Number of Maternal Participants with AEs Leading to Discontinuation Day 1 to Month 12 (12 months postdelivery) Number of Maternal Participants With Pregnancy Outcomes Day 1 to Month 12 (12 months postdelivery) Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
Number of Infant Participants With Birth Outcomes Day 1 (birth) to Month 12 Birth outcomes will include gestational age and anthropometric measurements.
- Secondary Outcome Measures
Name Time Method GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants Day 1 (birth), and Months 2, 6, and 12 Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants Day 1, Day 29, delivery, and Month 6 (6 months postdelivery) GMC of Serum RSV-F Binding Antibodies in Infant Participants Day 1 (birth), and Months 2, 6, and 12 Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants Day 29, delivery, and Month 6 (6 months postdelivery) Percentage of Maternal Participants With ≥4-fold Increase From Baseline in Neutralizing Antibody Titers and Binding Antibody Concentrations Baseline up to Month 6 (6 months postdelivery) Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Trial Locations
- Locations (56)
Clinical Research Prime - ClinEdge - PPDS
🇺🇸Idaho Falls, Idaho, United States
Bingham Memorial Hospital
🇺🇸Pocatello, Idaho, United States
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
🇺🇸Dothan, Alabama, United States
Applied Research Center of Arkansas - ClinEdge - PPDS
🇺🇸Little Rock, Arkansas, United States
Matrix Clinical Research - Gardena
🇺🇸Gardena, California, United States
Matrix Clinical Research - Huntington Park
🇺🇸Huntington Park, California, United States
Matrix Clinical Research, Inc - Corporate Office
🇺🇸Los Angeles, California, United States
Boeson Research MSO - Missoula - ERN - PPDS
🇺🇸Missoula, Montana, United States
Clinical Research Prime - ClinEdge - Rexburg - PPDS
🇺🇸Rexburg, Idaho, United States
Boeson Research GTF - Great Falls - ERN - PPDS
🇺🇸Great Falls, Montana, United States
Boeson Research KAL - Kalispell - ERN - PPDS
🇺🇸Kalispell, Montana, United States
Watching Over Mothers & Babies
🇺🇸Tucson, Arizona, United States
Aarhus Universitetshospital
🇩🇰Aarhus, Central Jutland, Denmark
Abby's Research Institute
🇺🇸Phoenix, Arizona, United States
Velocity Clinical Research - Covington - PPDS
🇺🇸Covington, Louisiana, United States
Saginaw Valley Medical Research Group LLC
🇺🇸Saginaw, Michigan, United States
Velocity Clinical Research (Grand Island - Nebraska) - PPDS
🇺🇸Grand Island, Nebraska, United States
Velocity Clinical Research (Hastings - Nebraska) - PPDS
🇺🇸Hastings, Nebraska, United States
Velocity Clinical Research (Norfolk - Nebraska) - PPDS
🇺🇸Norfolk, Nebraska, United States
DM Clinical Research - Bellaire - ERN - PPDS
🇺🇸Houston, Texas, United States
Maximos OB/GYN
🇺🇸League City, Texas, United States
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Maternal Fetal Diagnostics Center
🇺🇸Salt Lake City, Utah, United States
Dalhousie University - 5820 University Ave
🇨🇦Halifax, Nova Scotia, Canada
Sainte Justine Hospital
🇨🇦Montréal, Quebec, Canada
Centre Hospitalier de l'Université Laval
🇨🇦Quebec, Canada
Clínica Universidad de los Andes
🇨🇱Las Condes, Región-MetropolitanadeSantiago, Chile
Centro Internacional de Estudios Clínicos
🇨🇱Recoleta, Región-MetropolitanadeSantiago, Chile
Red Hospital Clinico de la Universidad de Chile
🇨🇱Santiago, Chile
Hvidovre Hospital
🇩🇰Hvidovre, Capital, Denmark
Regionshospitalet Gødstrup
🇩🇰Herning, Central Jutland, Denmark
Shonan Kamakura General Hospital
🇯🇵Kamakura-Shi, Kanagawa, Japan
Saiseikai Yokohamashi Nanbu Hospital
🇯🇵Yokohama, Kanagawa, Japan
Saitama City Hospital
🇯🇵Saitama-Shi, Saitama, Japan
Center Hospital of the National Center for Global Health and Medicine
🇯🇵Shinjuku-Ku, Tokyo, Japan
Centro De Vacunacion Internacional, S.A. (Cevaxin) - David
🇵🇦David, Chiriquí, Panama
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede La Chorrera
🇵🇦Ciudad De Panamá, Panama
Setshaba Research Centre
🇿🇦Soshanguve, Gauteng, South Africa
Centro De Vacunacion Internacional, S.A. (Cevaxin)
🇵🇦Ciudad De Panamá, Panama
WITS Clinical Research Site - PPDS
🇿🇦Soweto, Gauteng, South Africa
Merclinico Middelburg
🇿🇦Middelburg, Mpumalanga, South Africa
FAM-CRU
🇿🇦Cape Town, Western Cape, South Africa
Southampton General Hospital
🇬🇧Southampton, Hampshire, United Kingdom
The Royal Free Hospital
🇬🇧London, Middlesex, United Kingdom
Cardiff & Vale University Health Board-PPDS
🇬🇧Cardiff, South Glamorgan, United Kingdom
CEVAXIN 24 de diciembre
🇵🇦Panamá, Panama
Instituto de Investigaciones Científicas Y Servicios de Alta Tecnología Asociación de Interés Panama
🇵🇦Pueblo Nuevo, Panama
Ubuntu Clinical Research
🇿🇦Krugersdorp, Gauteng, South Africa
Josha Research
🇿🇦Bloemfontein, Free State, South Africa
Drs. YAK Vahed & Partners
🇿🇦Welkom, Free State, South Africa
Bothe ke Bontle Health Services-316 Kuit st
🇿🇦Pretoria, Gauteng, South Africa
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
The Royal London Hospital
🇬🇧London, London, City Of, United Kingdom
St George's Hospital
🇬🇧London, Surrey, United Kingdom
Glasgow Clinical Research Facility - PPDS
🇬🇧Glasgow, United Kingdom