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NCT02608502 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults

A Phase 3 study of Respiratory Syncytial Virus (RSV), sponsored by Novavax.

Completed
Registry status
Phase 3
Development phase
11,850
Enrollment target
20
Study locations

NCT02608502 is a Phase 3 study of Respiratory Syncytial Virus (RSV) that has completed, run by Novavax. The registered enrollment target is 11,850 participants, above the 5,679-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT02608502, a Phase 3 study of Respiratory Syncytial Virus (RSV), has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 3
Development phase
11,850 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.

Conditions Studied

Respiratory Syncytial Virus (RSV)

Interventions

  • BIOLOGICAL RSV-F Vaccine
  • BIOLOGICAL Phosphate Buffer Placebo

Study Locations (20)

Arizona

  • Research Site US046 - Mesa
  • Research Site US054 - Phoenix
  • Research Site US048 - Tempe

California

  • Research Site US005 - Anaheim
  • Research Site US028 - Redding
  • Research Site US064 - San Diego

Kansas

  • Research Site US003 - Lenexa
  • Research Site US052 - Newton
  • Research Site US058 - Wichita

Alabama

  • Research Site US062 - Birmingham
  • Research Site US061 - Mobile

Georgia

  • Research Site US045 - Savannah
  • Research Site US013 - Stockbridge

Illinois

  • Research Site US069 - Chicago
  • Research Site US065 - Peoria

Louisiana

  • Research Site US068 - Metairie
  • Research Site US039 - Metairie

Idaho

  • Research Site US012 - Boise

Trial Details

FieldValue
Enrollment Target 11,850 participants
Start Date 2015-11
Est. Completion 2016-12
Phase Phase 3

Sponsor

Novavax

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02608502

The ClinicalTrials.gov registry entry for NCT02608502 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 11,850 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 5,679-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (109% higher). The listed sponsor is Novavax, which has 31 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 RSV-F Vaccine is the first listed.

NCT02608502 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Arizona, California, Kansas.

Frequently Asked Questions

What is clinical trial NCT02608502 about?

NCT02608502 is a clinical study titled "A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults". The purpose of this study is to demonstrate the efficacy of the RSV F vaccine at a dose of 135µg via intramuscular (IM) injection in the prevention of moderate-severe RSV-associated lower respiratory tract disease (RSV-LRTD) in older adults ≥ 60 years of age.

What is the current status of trial NCT02608502?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 11,850 participants. The study started on 2015-11. Estimated completion is 2016-12.

What conditions does trial NCT02608502 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).

What interventions are being tested in trial NCT02608502?

The interventions under investigation include: RSV-F Vaccine (BIOLOGICAL), Phosphate Buffer Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT02608502?

This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02608502 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.