CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 128 enrolled
Drug / intervention
RSVpreF 120 µg +1 morebiological
Likely dose
RSVpreF 120 µgfrom 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/NCT05900154
NCT05900154Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE

Pfizer·interventional·Posted Jun 12, 2023·Updated Mar 6, 2025

In Brief

A Phase 1 clinical trial evaluating RSVpreF 120 µg and RSVpreF 60 µg for RESPIRATORY SYNCYTIAL VIRUS (RSV). Completed, enrolled 128 participants across 17 sites.

Detailed Summary

The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to \<18 years of age. This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRESPIRATORY SYNCYTIAL VIRUS (RSV)
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedJun 12, 2023
Enrollment StartJun 22, 2023
Primary CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 3.1 years ago

Interventions

RSVpreF 120 µgbiological

RSVpreF standard dose level

RSVpreF 60 µgbiological

RSVpreF low dose level