Clinical trial NCT02608502: A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
Official title: A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus (RSV)
Lead sponsor: Novavax
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 11850
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Numbers and percentages of subjects with moderate-severe RSV-LRTD
timeFrame: Day 0 to Day 182
measure: Numbers and percentages of subjects with solicited local and systemic AEs
timeFrame: Day 0 to Day 364
Secondary outcomes:
measure: Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)
timeFrame: Day 0 to Day 182
measure: RSV F protein antibody expressed as ELISA Units (EU).
timeFrame: Day 0 to Day 364
measure: Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA
timeFrame: Day 0 to Day 364
measure: Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain
timeFrame: Day 0 to Day 28
measure: Number and percentage of subjects with RSV-ARD and/or RSV-LRTD
timeFrame: Day 0 to Day 364
measure: 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.
timeFrame: Day 0 to Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site US062
state: Alabama
city: Mobile
country: United States
facility: Research Site US061
state: Alabama
city: Mesa
country: United States
facility: Research Site US046
state: Arizona
city: Phoenix
country: United States
facility: Research Site US054
state: Arizona
city: Tempe
country: United States
facility: Research Site US048
state: Arizona
city: Anaheim
country: United States
facility: Research Site US005
state: California
city: Redding
country: United States
facility: Research Site US028
state: California
city: San Diego
country: United States
facility: Research Site US064
state: California
city: Savannah
country: United States
facility: Research Site US045
state: Georgia
city: Stockbridge
country: United States
facility: Research Site US013
state: Georgia
city: Boise
country: United States
facility: Research Site US012
state: Idaho
city: Chicago
country: United States
facility: Research Site US069
state: Illinois
city: Peoria
country: United States
facility: Research Site US065
state: Illinois
city: Lenexa
country: United States
facility: Research Site US003
state: Kansas
city: Newton
country: United States
facility: Research Site US052
state: Kansas
city: Wichita
country: United States
facility: Research Site US058
state: Kansas
city: Lexington
country: United States
facility: Research Site US080
state: Kentucky
city: Metairie
country: United States
facility: Research Site US068
state: Louisiana
city: Metairie
country: United States
facility: Research Site US039
state: Louisiana
city: Methuen
country: United States
facility: Research Site US055
state: Massachusetts
city: Edina
country: United States
facility: Research Site US072
state: Minnesota
city: Kansas City
country: United States
facility: Research Site US051
state: Missouri
city: Saint Louis
country: United States
facility: Research Site US076
state: Missouri
city: Norfolk
country: United States
facility: Research Site US025
state: Nebraska
city: Omaha
country: United States
facility: Research Site US018
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site US057
state: Nevada
city: Newington
country: United States
facility: Research Site US059
state: New Hampshire
city: Binghamton
country: United States
facility: Research Site US066
state: New York
city: Endwell
country: United States
facility: Research Site US017
state: New York
city: Rochester
country: United States
facility: Research Site US049
state: New York
city: Cary
country: United States
facility: Research Site US078
state: North Carolina
city: Durham
country: United States
facility: Research Site US020
state: North Carolina
city: Wilmington
country: United States
facility: Research Site US071
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site US063
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site US081
state: Ohio
city: Cincinnati
country: United States
facility: Research Site US085
state: Ohio
city: Cleveland
country: United States
facility: Research Site US030
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site US053
state: Oklahoma
city: Warwick
country: United States
facility: Research Site US044
state: Rhode Island
city: Charleston
country: United States
facility: Research Site US070
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site US056
state: South Carolina
city: Mount Pleasant
country: United States
facility: Research Site US079
state: South Carolina
city: Dakota Dunes
country: United States
facility: Research Site US050
state: South Dakota
city: Bristol
country: United States
facility: Research Site US074
state: Tennessee
city: Knoxville
country: United States
facility: Research Site US077
state: Tennessee
city: Nashville
country: United States
facility: Research Site US029
state: Tennessee
city: Austin
country: United States
facility: Research Site US047
state: Texas
city: Dallas
country: United States
facility: Research Site US010
state: Texas
city: Fort Worth
country: United States
facility: Research Site US083
state: Texas
city: Fort Worth
country: United States
facility: Research Site US060
state: Texas
city: Houston
country: United States
facility: Research Site US019
state: Texas
city: San Angelo
country: United States
facility: Research Site US084
state: Texas
city: Tomball
country: United States
facility: Research Site US073
state: Texas
city: Salt Lake City
country: United States
facility: Research Site US082
state: Utah
city: Salt Lake City
country: United States
facility: Research Site US075
state: Utah
city: Salt Lake City
country: United States
facility: Research Site US008
state: Utah
city: West Jordan
country: United States
facility: Research Site US027
state: Utah
city: Norfolk
country: United States
facility: Research Site US067
state: Virginia
city: Seattle
country: United States
facility: Research Site US026
state: Washington
city: Marshfield
country: United States
facility: Research Site US024
state: Wisconsin
Study officials:
affiliation: Novavax, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References: