This trial is active, not recruiting.

Condition respiratory syncytial virus (rsv)
Treatments rsv-f vaccine, phosphate buffer placebo
Phase phase 3
Sponsor Novavax
Start date November 2015
End date December 2016
Trial size 11850 participants
Trial identifier NCT02608502, RSV-E-301


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
RSV-F Vaccine (0.5mL Injection)
rsv-f vaccine
(Placebo Comparator)
Phosphate Buffer Placebo (0.5mL Injection)
phosphate buffer placebo

Primary Outcomes

Numbers and percentages of subjects with moderate-severe RSV-LRTD
time frame: Day 0 to Day 182
Numbers and percentages of subjects with solicited local and systemic AEs
time frame: Day 0 to Day 364

Secondary Outcomes

Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)
time frame: Day 0 to Day 182
RSV F protein antibody expressed as ELISA Units (EU).
time frame: Day 0 to Day 364
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
time frame: Day 0 to Day 364
Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain
time frame: Day 0 to Day 28
Number and percentage of subjects with RSV-ARD and/or RSV-LRTD
time frame: Day 0 to Day 364
Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2015-16 IIV at Day 28 in the subset of subjects in each treatment group that receive IIV concurrently with study test article.
time frame: Day 0 to Day 28

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: 1. Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjects may have one or more chronic medical diagnoses, but should be clinically stable as assessed by: - Absence of changes in medical therapy within one month due to treatment failure or toxicity, - Absence of medical events qualifying as SAEs within one month of the planned vaccination on Day 0, and - Absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, render survival to completion of the protocol unlikely. 2. Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment. 3. Able to comply with study requirements; including access to transportation for study visits. 4. Access to inbound and outbound telephone communication with caregivers and study staff. Exclusion Criteria: 1. Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination. 2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization. 3. Receipt of any vaccine other than an IIV in the 4 weeks preceding the study vaccination or a pneumococcal vaccine in the 2 weeks preceding the study vaccination; or any RSV vaccine at any time. 4. Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination. 5. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. An immunosuppressant dose of glucocorticoid will be defined as a systemic dose ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted. 6. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 7. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥38.0°C on the planned day of vaccine administration). 8. Known uncontrolled disorder of coagulation. Potential subjects receiving aspirin, clopidogrel, prasugrel, dipyridamole, dabigatran, apixaban, rivaroxaban or warfarin under good control for cardiovascular prophylaxis or prophylaxis of thromboembolic disease or stroke in the setting of atrial fibrillation will NOT be excluded. 9. Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse. 10. Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic, cognitive, or psychiatric conditions deemed likely to impair the quality of study compliance or safety reporting).

Additional Information

Official title A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novavax.