A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
NCT ID: NCT02608502
Last Updated: 2022-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
11850 participants
INTERVENTIONAL
2015-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment Group A
RSV-F Vaccine (0.5mL Injection)
RSV-F Vaccine
Treatment Group B
Phosphate Buffer Placebo (0.5mL Injection)
Phosphate Buffer Placebo
Interventions
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RSV-F Vaccine
Phosphate Buffer Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
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).
60 Years
ALL
Yes
Sponsors
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Novavax
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development
Role: STUDY_DIRECTOR
Novavax, Inc.
Locations
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Research Site US062
Birmingham, Alabama, United States
Research Site US061
Mobile, Alabama, United States
Research Site US046
Mesa, Arizona, United States
Research Site US054
Phoenix, Arizona, United States
Research Site US048
Tempe, Arizona, United States
Research Site US005
Anaheim, California, United States
Research Site US028
Redding, California, United States
Research Site US064
San Diego, California, United States
Research Site US045
Savannah, Georgia, United States
Research Site US013
Stockbridge, Georgia, United States
Research Site US012
Boise, Idaho, United States
Research Site US069
Chicago, Illinois, United States
Research Site US065
Peoria, Illinois, United States
Research Site US003
Lenexa, Kansas, United States
Research Site US052
Newton, Kansas, United States
Research Site US058
Wichita, Kansas, United States
Research Site US080
Lexington, Kentucky, United States
Research Site US068
Metairie, Louisiana, United States
Research Site US039
Metairie, Louisiana, United States
Research Site US055
Methuen, Massachusetts, United States
Research Site US072
Edina, Minnesota, United States
Research Site US051
Kansas City, Missouri, United States
Research Site US076
St Louis, Missouri, United States
Research Site US025
Norfolk, Nebraska, United States
Research Site US018
Omaha, Nebraska, United States
Research Site US057
Las Vegas, Nevada, United States
Research Site US059
Newington, New Hampshire, United States
Research Site US066
Binghamton, New York, United States
Research Site US017
Endwell, New York, United States
Research Site US049
Rochester, New York, United States
Research Site US078
Cary, North Carolina, United States
Research Site US020
Durham, North Carolina, United States
Research Site US071
Wilmington, North Carolina, United States
Research Site US063
Winston-Salem, North Carolina, United States
Research Site US081
Cincinnati, Ohio, United States
Research Site US085
Cincinnati, Ohio, United States
Research Site US030
Cleveland, Ohio, United States
Research Site US053
Oklahoma City, Oklahoma, United States
Research Site US044
Warwick, Rhode Island, United States
Research Site US070
Charleston, South Carolina, United States
Research Site US056
Mt. Pleasant, South Carolina, United States
Research Site US079
Mt. Pleasant, South Carolina, United States
Research Site US050
Dakota Dunes, South Dakota, United States
Research Site US074
Bristol, Tennessee, United States
Research Site US077
Knoxville, Tennessee, United States
Research Site US029
Nashville, Tennessee, United States
Research Site US047
Austin, Texas, United States
Research Site US010
Dallas, Texas, United States
Research Site US083
Fort Worth, Texas, United States
Research Site US060
Fort Worth, Texas, United States
Research Site US019
Houston, Texas, United States
Research Site US084
San Angelo, Texas, United States
Research Site US073
Tomball, Texas, United States
Research Site US082
Salt Lake City, Utah, United States
Research Site US075
Salt Lake City, Utah, United States
Research Site US008
Salt Lake City, Utah, United States
Research Site US027
West Jordan, Utah, United States
Research Site US067
Norfolk, Virginia, United States
Research Site US026
Seattle, Washington, United States
Research Site US024
Marshfield, Wisconsin, United States
Countries
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Related Links
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Novavax Webpage
Other Identifiers
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RSV-E-301
Identifier Type: -
Identifier Source: org_study_id
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