Trials / Completed
CompletedNCT05900154
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RSVpreF 120 µg | RSVpreF standard dose level |
| BIOLOGICAL | RSVpreF 60 µg | RSVpreF low dose level |
Timeline
- Start date
- 2023-06-22
- Primary completion
- 2024-02-29
- Completion
- 2024-02-29
- First posted
- 2023-06-12
- Last updated
- 2025-03-06
- Results posted
- 2025-03-06
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05900154. Inclusion in this directory is not an endorsement.