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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novavax
ClinicalTrials.gov Identifier:
NCT02608502
First received: November 10, 2015
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Respiratory Syncytial Virus (RSV)
Biological: RSV-F Vaccine
Biological: Phosphate Buffer Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults

Further study details as provided by Novavax:

Primary Outcome Measures:
  • 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.

  • 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:
  • 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.

  • 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)

  • 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)

  • 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)

  • 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.

  • 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 ]

Enrollment: 11850
Study Start Date: November 2015
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02608502

  Show 50 Study Locations
Sponsors and Collaborators
Novavax
Investigators
Study Director: D. Nigel Thomas, Ph.D Novavax, Inc.
  More Information

Additional Information:
Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT02608502     History of Changes
Other Study ID Numbers: RSV-E-301
Study First Received: November 10, 2015
Last Updated: January 10, 2017

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

ClinicalTrials.gov processed this record on April 21, 2017