NCT07041190View on ClinicalTrials.gov

Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.

PHASE3Not yet recruitingINTERVENTIONAL

Enrollment

1,500

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

November 30, 2028

Study Completion Date

December 31, 2028

Conditions

RSV Immunization

Interventions

DRUG

Abrysvo

Maternal RSV Vaccine (MV). RSV bivalent recombinant vaccine with subgroup A and B stabilised prefusion F antigens, single intramuscular injection of 0.5 mL, administered once, in pregnancy.

DRUG

Nirsevimab

Infant RSV monoclonal antibody (mAb). For infants \<5kg: 50mg (0.5mL in pre-filled syringe), for infants ≥5kg: 100mg (1mL in pre-filled syringe), administered as a single intramuscular injection.

All Listed Sponsors

lead

PENTA Foundation

NETWORK