CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,636 enrolled
Drug / intervention
RSV F vaccine with adjuvant +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02624947
NCT02624947Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine With Aluminum in Healthy Third-trimester Pregnant Women; and Safety and Efficacy of Maternally Transferred Antibodies in Preventing RSV Disease in Their Infants

Novavax·interventional·Posted Dec 9, 2015·Updated May 6, 2025

In Brief

A Phase 3 clinical trial evaluating RSV F vaccine with adjuvant and Formulation buffer for Respiratory Syncytial Virus Infections. Completed, enrolled 4,636 participants across 88 sites in 11 countries.

Detailed Summary

The purpose of this study is to determine the efficacy of maternal immunization during the third trimester of pregnancy with the RSV F vaccine against medically-significant RSV lower respiratory tract infection (LRTI), as defined by hypoxemia or tachypnea at rest, through the first 90, 120, 150, and 180 days of life in infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Syncytial Virus Infections
CountriesArgentina, Australia, Bangladesh, Chile, Mexico, New Zealand, Philippines, South Africa, Spain, United Kingdom, United States
CollaboratorsBill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 9, 2015
Enrollment StartDec 1, 2015
Primary CompletionDec 28, 2018
Study CompletionJul 12, 2019
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.6 years ago

Interventions

RSV F vaccine with adjuvantbiological

Formulation bufferbiological