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

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ClinicalTrials.gov Identifier: NCT02608502
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Novavax

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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus (RSV) Biological: RSV-F Vaccine Biological: Phosphate Buffer Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults
Actual Study Start Date : November 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Treatment Group A
RSV-F Vaccine (0.5mL Injection)
Biological: RSV-F Vaccine
Placebo Comparator: Treatment Group B
Phosphate Buffer Placebo (0.5mL Injection)
Biological: Phosphate Buffer Placebo



Primary Outcome Measures :
  1. Numbers and percentages of subjects with moderate-severe RSV-LRTD [ Time Frame: Day 0 to Day 182 ]
    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.

  2. Numbers and percentages of subjects with solicited local and systemic AEs [ Time Frame: Day 0 to Day 364 ]
    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.


Secondary Outcome Measures :
  1. Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD) [ Time Frame: Day 0 to Day 182 ]
    Defined by the presence of at least one (1) of: rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath; plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.

  2. RSV F protein antibody expressed as ELISA Units (EU). [ Time Frame: Day 0 to Day 364 ]

    Summarized by:

    • Geometric Mean Concentrations as EU (GMEU)
    • Geometric Mean Ratio (GMR)
    • Seroresponse Rate (SRR)

  3. Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA [ Time Frame: Day 0 to Day 364 ]

    Summarized by:

    • Geometric Mean Concentrations as EU (GMEU)
    • Geometric Mean Fold Rise (GMFR)

  4. Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain [ Time Frame: Day 0 to Day 28 ]

    Summarized by:

    • Geometric Mean Titer (GMT)
    • Geometric Mean Ratio (GMR)

  5. Number and percentage of subjects with RSV-ARD and/or RSV-LRTD [ Time Frame: Day 0 to Day 364 ]
    Summarized by treatment group and by age strata and in strata defined by comorbidities and type of community housing.

  6. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608502


  Hide Study Locations
Locations
United States, Alabama
Research Site US062
Birmingham, Alabama, United States, 35216
Research Site US061
Mobile, Alabama, United States, 36608
United States, Arizona
Research Site US046
Mesa, Arizona, United States, 85206
Research Site US054
Phoenix, Arizona, United States, 85050
Research Site US048
Tempe, Arizona, United States, 85283
United States, California
Research Site US005
Anaheim, California, United States, 92801
Research Site US028
Redding, California, United States, 96001
Research Site US064
San Diego, California, United States, 92117
United States, Georgia
Research Site US045
Savannah, Georgia, United States, 31406
Research Site US013
Stockbridge, Georgia, United States, 30281
United States, Idaho
Research Site US012
Boise, Idaho, United States, 83642
United States, Illinois
Research Site US069
Chicago, Illinois, United States, 60654
Research Site US065
Peoria, Illinois, United States, 61614
United States, Kansas
Research Site US003
Lenexa, Kansas, United States, 66219
Research Site US052
Newton, Kansas, United States, 67114
Research Site US058
Wichita, Kansas, United States, 67207
United States, Kentucky
Research Site US080
Lexington, Kentucky, United States, 40509
United States, Louisiana
Research Site US068
Metairie, Louisiana, United States, 70002
Research Site US039
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Research Site US055
Methuen, Massachusetts, United States, 01844
United States, Minnesota
Research Site US072
Edina, Minnesota, United States, 55435
United States, Missouri
Research Site US051
Kansas City, Missouri, United States, 64114
Research Site US076
Saint Louis, Missouri, United States, 63141
United States, Nebraska
Research Site US025
Norfolk, Nebraska, United States, 68701
Research Site US018
Omaha, Nebraska, United States, 68134
United States, Nevada
Research Site US057
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Research Site US059
Newington, New Hampshire, United States, 03801
United States, New York
Research Site US066
Binghamton, New York, United States, 13901
Research Site US017
Endwell, New York, United States, 13760
Research Site US049
Rochester, New York, United States, 14609
United States, North Carolina
Research Site US078
Cary, North Carolina, United States, 27518
Research Site US020
Durham, North Carolina, United States, 27710
Research Site US071
Wilmington, North Carolina, United States, 28401
Research Site US063
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Site US081
Cincinnati, Ohio, United States, 45219
Research Site US085
Cincinnati, Ohio, United States, 45227
Research Site US030
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Research Site US053
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Research Site US044
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Research Site US070
Charleston, South Carolina, United States, 29407
Research Site US056
Mount Pleasant, South Carolina, United States, 29464
Research Site US079
Mount Pleasant, South Carolina, United States, 29464
United States, South Dakota
Research Site US050
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
Research Site US074
Bristol, Tennessee, United States, 37620
Research Site US077
Knoxville, Tennessee, United States, 37920
Research Site US029
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site US047
Austin, Texas, United States, 78705
Research Site US010
Dallas, Texas, United States, 75234
Research Site US083
Fort Worth, Texas, United States, 76104
Research Site US060
Fort Worth, Texas, United States, 76135
Research Site US019
Houston, Texas, United States, 77030
Research Site US084
San Angelo, Texas, United States, 76904
Research Site US073
Tomball, Texas, United States, 77375
United States, Utah
Research Site US082
Salt Lake City, Utah, United States, 84109
Research Site US075
Salt Lake City, Utah, United States, 84121
Research Site US008
Salt Lake City, Utah, United States, 84124
Research Site US027
West Jordan, Utah, United States, 84088
United States, Virginia
Research Site US067
Norfolk, Virginia, United States, 23507
United States, Washington
Research Site US026
Seattle, Washington, United States, 98101
United States, Wisconsin
Research Site US024
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D Novavax, Inc.

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT02608502     History of Changes
Other Study ID Numbers: RSV-E-301
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs