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

NCT02608502 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11850

Last updated 2022-07-19

No results posted yet for this 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

  • Respiratory Syncytial Virus (RSV)

Interventions

BIOLOGICAL

RSV-F Vaccine

BIOLOGICAL

Phosphate Buffer Placebo

Sponsors & Collaborators

  • Novavax

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Novavax, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608502 on ClinicalTrials.gov