Last updated on November 2018

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Brief description of study

The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.

Detailed Study Description

This is a randomized, observer-blind, placebo-controlled group-sequential design trial enrolling third-trimester pregnant women in the Northern and Southern hemispheres, for up to four consecutive RSV seasons in each hemisphere. The trial is projected to enroll an estimated maximum of 8,618 third-trimester pregnant subjects, but numbers may be smaller based on the operation of the group-sequential design, the incidence rate of the primary clinical endpoint events, and the efficacy of the intervention. Women in the third trimester of a singleton uncomplicated pregnancy and 18 to 40 years of age (inclusive) will be enrolled and randomized in a 1:1 ratio into one of two treatment groups, active or placebo, over approximately the three months prior to peak RSV season. After the first global season of enrollment, the randomization scheme will be changes to a 2:1 (active/placebo) ratio to enable more efficient accrual of the safety database.

All maternal subjects will receive a single intramuscular (IM) injection on Day 0 with the assigned test article, the RSV F vaccine or placebo. Study participation for maternal subjects will span approximately nine (9) months from the first dose, ending six (6) months post-delivery. Study follow-up for infant subjects who are consented will span approximately one (1) year post-delivery.

Clinical Study Identifier: NCT02624947

Contact Investigators or Research Sites near you

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D Nigel Thomas, PhD

Research Site ZA009
Paarl, South Africa