At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 1,153 enrolled
Drug / intervention
RSV vaccine +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.
A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS
In Brief
A Phase 2 clinical trial evaluating RSV vaccine and Placebo for Respiratory Tract Infection. Completed, enrolled 1,153 participants across 159 sites in 5 countries.
Detailed Summary
This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Tract Infection
CountriesArgentina, Chile, New Zealand, South Africa, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2019
Enrollment StartAug 2019
Primary CompletionSep 2021
TodayJul 2026
First PostedJul 25, 2019
Enrollment StartAug 7, 2019
Primary CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.9 years ago
Interventions
RSV vaccinebiological
RSV vaccine
Placebobiological
Normal saline solution for injection (0.9% sodium chloride injection)