At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 14,727 enrolled
Drug / intervention
RSVpreF +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 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY
In Brief
A Phase 3 clinical trial evaluating RSVpreF and Placebo for Respiratory Tract Infection. Completed, enrolled 14,727 participants across 464 sites in 18 countries.
Detailed Summary
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiratory Tract Infection
CountriesArgentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, Netherlands, New Zealand, Philippines, South Africa, South Korea, Spain, Taiwan, The Gambia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJun 2020
Enrollment StartJun 2020
Primary CompletionOct 2023
TodayJul 2026
First PostedJun 9, 2020
Enrollment StartJun 17, 2020
Primary CompletionOct 27, 2023
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 6.1 years ago
Interventions
RSVpreFbiological
RSV vaccine (RSVpreF)
Placebobiological
Placebo