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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
360
Number of Maternal Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days post vaccination)
Number of Maternal Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days post vaccination)
Number of Maternal Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 to Month 6 (6 months postdelivery)
Number of Maternal Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants with AEs Leading to Discontinuation
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Maternal Participants With Pregnancy Outcomes
Pregnancy outcomes will include stillbirth, live birth, vaginal delivery, and cesarean section delivery.
Time frame: Day 1 to Month 12 (12 months postdelivery)
Number of Infant Participants with MAAEs
Time frame: Day 1 (birth) to Month 12
Number of Infant Participants with AESIs
Time frame: Day 1 (birth) to Month 12
Number of Infant Participants with SAEs
Time frame: Day 1 (birth) to Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
Dothan, Alabama, United States
Abby's Research Institute
Phoenix, Arizona, United States
Watching Over Mothers & Babies
Tucson, Arizona, 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
Clinical Research Prime - ClinEdge - PPDS
Idaho Falls, Idaho, United States
Bingham Memorial Hospital
Pocatello, Idaho, United States
Clinical Research Prime - ClinEdge - Rexburg - PPDS
Rexburg, Idaho, United States
...and 46 more locations
Number of Infant Participants With Birth Outcomes
Birth outcomes will include gestational age and anthropometric measurements.
Time frame: Day 1 (birth) to Month 12
Geometric Mean Titer (GMT) of Serum RSV-A and RSV-B Neutralizing Antibodies in Maternal Participants
Time frame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Concentration (GMC) of Serum RSV-F Binding Antibodies in Maternal Participants
Time frame: Day 1, Day 29, delivery, and Month 6 (6 months postdelivery)
Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations in Maternal Participants
Time frame: 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
Time frame: Baseline up to Month 6 (6 months postdelivery)
GMT of Serum RSV-A and RSV-B Neutralizing Antibodies in Infant Participants
Time frame: Day 1 (birth), and Months 2, 6, and 12
GMC of Serum RSV-F Binding Antibodies in Infant Participants
Time frame: Day 1 (birth), and Months 2, 6, and 12