- Can RSV vaccination during pregnancy reduce the burden of RSV-associated lower respiratory tract illness in newborns and infants?
Study design: Phase 3, double-blind, randomized controlled trial
Population
- Number of patients studied: 7358 (3682 in the vaccine group and 3676 in the placebo group)
- Inclusion criteria: Pregnant women at 24 through 36 weeks' gestation
- Exclusion criteria: Not specified in the provided text
Interventions
- Experimental group: Single intramuscular injection of 120 μg of a bivalent RSV prefusion F protein–based (RSVpreF) vaccine
- Control group: Placebo injection
Primary outcome
- Medically attended severe RSV-associated lower respiratory tract illness and medically attended RSV-associated lower respiratory tract illness in infants within 90, 120, 150, and 180 days after birth
Secondary outcomes: RSV-associated hospitalization within 90 days and 180 days after birth
Safety outcomes or Adverse Events: Adverse events reported within 1 month after injection or within 1 month after birth in the vaccine group (13.8% of women and 37.1% of infants) and the placebo group (13.1% and 34.5%, respectively)
Conclusion
RSVpreF vaccine administered during pregnancy was effective against medically attended severe RSV-associated lower respiratory tract illness in infants, and no safety concerns were identified.