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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 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.

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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.

Conditions Studied

Respiratory Syncytial Virus (RSV)

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

FieldValue
Enrollment Target 128 participants
Start Date 2023-06-22
Est. Completion 2024-02-29
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT05900154

The ClinicalTrials.gov registry entry for NCT05900154 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,744-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (98% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.