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

NCT02608502 | Completed Phase 3

• 1 other identifier: RSV-E-301
• Study Type: interventional
• Target: 11,850
• Locations: 1 country
• Sites: 60

Brief 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)

Outcome Measures

Primary Outcomes (2)

• Numbers and percentages of subjects with moderate-severe RSV-LRTD

  Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.

  Day 0 to Day 182

• Numbers and percentages of subjects with solicited local and systemic AEs

  Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.

  Day 0 to Day 364

Secondary Outcomes (6)

• Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)

  Day 0 to Day 182

• RSV F protein antibody expressed as ELISA Units (EU).

  Day 0 to Day 364

• Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA

  Day 0 to Day 364

• Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain

  Day 0 to Day 28

• Number and percentage of subjects with RSV-ARD and/or RSV-LRTD

  Day 0 to Day 364

Study Arms (2)

Treatment Group A

EXPERIMENTAL

RSV-F Vaccine (0.5mL Injection)

Biological: RSV-F Vaccine

Treatment Group B

PLACEBO COMPARATOR

Phosphate Buffer Placebo (0.5mL Injection)

Biological: Phosphate Buffer Placebo

Interventions

RSV-F Vaccine BIOLOGICAL

Treatment Group A

Phosphate Buffer Placebo BIOLOGICAL

Treatment Group B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willing and able (on both a physical and cognitive basis) to give informed consent prior to study enrollment.
• Able to comply with study requirements; including access to transportation for study visits.
• Access to inbound and outbound telephone communication with caregivers and study staff.

You may not qualify if:

• Participation in research involving investigational product (drug / biologic / device) within 45 days before the planned date of the Day 0 vaccination.
• History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization.
• 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.
• Any known or suspected immunosuppressive condition, acquired or congenital, as determined by history and/or physical examination.
• 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.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
• 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).
• 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.
• Suspicion or recent history (within one year of planned vaccination) of alcohol or other substance abuse.
• 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).

Sponsors & Collaborators

• Novavax: lead

Study Sites (60)

Research Site US062

Birmingham, Alabama, 35216, United States

Location

Research Site US061

Mobile, Alabama, 36608, United States

Location

Research Site US046

Mesa, Arizona, 85206, United States

Location

Research Site US054

Phoenix, Arizona, 85050, United States

Location

Research Site US048

Tempe, Arizona, 85283, United States

Location

Research Site US005

Anaheim, California, 92801, United States

Location

Research Site US028

Redding, California, 96001, United States

Location

Research Site US064

San Diego, California, 92117, United States

Location

Research Site US045

Savannah, Georgia, 31406, United States

Location

Research Site US013

Stockbridge, Georgia, 30281, United States

Location

Research Site US012

Boise, Idaho, 83642, United States

Location

Research Site US069

Chicago, Illinois, 60654, United States

Location

Research Site US065

Peoria, Illinois, 61614, United States

Location

Research Site US003

Lenexa, Kansas, 66219, United States

Location

Research Site US052

Newton, Kansas, 67114, United States

Location

Research Site US058

Wichita, Kansas, 67207, United States

Location

Research Site US080

Lexington, Kentucky, 40509, United States

Location

Research Site US068

Metairie, Louisiana, 70002, United States

Location

Research Site US039

Metairie, Louisiana, 70006, United States

Location

Research Site US055

Methuen, Massachusetts, 01844, United States

Location

Research Site US072

Edina, Minnesota, 55435, United States

Location

Research Site US051

Kansas City, Missouri, 64114, United States

Location

Research Site US076

St Louis, Missouri, 63141, United States

Location

Research Site US025

Norfolk, Nebraska, 68701, United States

Location

Research Site US018

Omaha, Nebraska, 68134, United States

Location

Research Site US057

Las Vegas, Nevada, 89119, United States

Location

Research Site US059

Newington, New Hampshire, 03801, United States

Location

Research Site US066

Binghamton, New York, 13901, United States

Location

Research Site US017

Endwell, New York, 13760, United States

Location

Research Site US049

Rochester, New York, 14609, United States

Location

Research Site US078

Cary, North Carolina, 27518, United States

Location

Research Site US020

Durham, North Carolina, 27710, United States

Location

Research Site US071

Wilmington, North Carolina, 28401, United States

Location

Research Site US063

Winston-Salem, North Carolina, 27103, United States

Location

Research Site US081

Cincinnati, Ohio, 45219, United States

Location

Research Site US085

Cincinnati, Ohio, 45227, United States

Location

Research Site US030

Cleveland, Ohio, 44122, United States

Location

Research Site US053

Oklahoma City, Oklahoma, 73112, United States

Location

Research Site US044

Warwick, Rhode Island, 02886, United States

Location

Research Site US070

Charleston, South Carolina, 29407, United States

Location

Research Site US056

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Site US079

Mt. Pleasant, South Carolina, 29464, United States

Location

Research Site US050

Dakota Dunes, South Dakota, 57049, United States

Location

Research Site US074

Bristol, Tennessee, 37620, United States

Location

Research Site US077

Knoxville, Tennessee, 37920, United States

Location

Research Site US029

Nashville, Tennessee, 37203, United States

Location

Research Site US047

Austin, Texas, 78705, United States

Location

Research Site US010

Dallas, Texas, 75234, United States

Location

Research Site US083

Fort Worth, Texas, 76104, United States

Location

Research Site US060

Fort Worth, Texas, 76135, United States

Location

Research Site US019

Houston, Texas, 77030, United States

Location

Research Site US084

San Angelo, Texas, 76904, United States

Location

Research Site US073

Tomball, Texas, 77375, United States

Location

Research Site US082

Salt Lake City, Utah, 84109, United States

Location

Research Site US075

Salt Lake City, Utah, 84121, United States

Location

Research Site US008

Salt Lake City, Utah, 84124, United States

Location

Research Site US027

West Jordan, Utah, 84088, United States

Location

Research Site US067

Norfolk, Virginia, 23507, United States

Location

Research Site US026

Seattle, Washington, 98101, United States

Location

Research Site US024

Marshfield, Wisconsin, 54449, United States

Location

Related Links

• Novavax Webpage

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

US (60)