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NCT05900154 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
A Phase 1 study of Respiratory Syncytial Virus (RSV), sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 17
- Study locations
NCT05900154: Completed Phase 1 study of Respiratory Syncytial Virus (RSV), sponsored by Pfizer.
NCT05900154 is a Phase 1 study of Respiratory Syncytial Virus (RSV) that has completed, run by Pfizer. The registered enrollment target is 128 participants, below the 6,744-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (98% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05900154, a Phase 1 study of Respiratory Syncytial Virus (RSV), has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 17
- Study locations
Study 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.
Primary Outcome
Local reactions were collected in the electronic diary (e-diary) from Day 1 through Day 7 after vaccination. Local reactions included pain at injection site, redness, and swelling. For participants greater than or equal to (\>=) 2 years to \<12 years of age, redness and swelling were graded as mild: 0.5 to 2.0 centimeter (cm), moderate: \>2.0 to 7.0 cm, and severe: \> 7 cm; for participants \>=12 years of age, mild: \> 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm, and severe: \>10 cm. Pain at injec
Conditions Studied
Interventions
- BIOLOGICAL RSVpreF 120 µg
- BIOLOGICAL RSVpreF 60 µg
Study Locations (17)
California
- Stanford University Medical Center - Palo Alto
- Peninsula Research Associates - Rolling Hills Estates
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Senders Pediatrics - South Euclid
Texas
- Innovo Research - Austin Regional Clinic - Austin
- Velocity Clinical Research, Austin - Austin
Washington
- Seattle Children's - Building Cure - Seattle
- Seattle Children's Hospital - Seattle
Alabama
- University of Alabama at Birmingham - School of Medicine - Birmingham
Florida
- Bio-Medical Research LLC - Miami
Iowa
- Velocity Clinical Research, Sioux City - Sioux City
Louisiana
- Velocity Clinical Research, New Orleans - Metairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-06-22 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 1 |
What the finished NCT05900154 record still lists
NCT05900154 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 6,744-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Respiratory Syncytial Virus (RSV) appearing as the primary indexed condition, and to 2 interventions - of which RSVpreF 120 µg is the first listed.
NCT05900154 lists 17 locations in 13 states (California, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT05900154 about?
NCT05900154 is a clinical study titled "A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age". 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 stud...
What is the current status of trial NCT05900154?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2023-06-22. Estimated completion is 2024-02-29.
What conditions does trial NCT05900154 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).
What interventions are being tested in trial NCT05900154?
The interventions under investigation include: RSVpreF 120 µg (BIOLOGICAL), RSVpreF 60 µg (BIOLOGICAL).
Who is sponsoring clinical trial NCT05900154?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05900154 being conducted?
This trial has 17 study locations across Alabama, California, Florida, Iowa, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05900154's enrollment target sits among peer trials
128 9th of 11 higher than 3 of 11 other Respiratory Syncytial Virus (RSV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus (RSV) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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