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Review of: Madhi SA, Polack F, Piedra P et al. Respiratory syncytial virus vaccination during pregnancy and effects in infants. N Engl J Med 2020;383:426–39.
Design: Randomised placebo controlled trial.
Allocation: 1:1 (first global season) and 2:1 ratio (subsequent seasons) vaccine to placebo.
Blinding: Observer blind.
Setting: Multinational (87 sites in 11 countries).
Participants: 4636 healthy pregnant women aged 18–40 years between 28 and 36 weeks gestation. Exclusion criteria were essentially any mother with any underlying health condition or on any medication.
Intervention: Women were randomised to receive either single dose of intramuscular respiratory syncytial virus (RSV) F-protein vaccine or placebo vaccine.
Outcomes: Primary outcome was vaccine efficacy (VE) of prevention of medically significant RSV lower respiratory tract infection (MS-RSV …
Contributors CW wrote the first draft of the abstract and commentary, LCW edited and added to both.
Provenance and peer review Not commissioned; internally peer reviewed.