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Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02266628
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : June 6, 2017
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of the RSV- F Vaccine in elderly subjects, as well as rate the incidence of medically- attended RSV disease in vaccine and placebo recipients.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus (RSV) Biological: RSV-F Vaccine Biological: Saline Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1599 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Observer-Blind, Placebo- Controlled Study to Evaluate the Immunogenicity and Safety of Respiratory Syncytial Virus (RSV) F Vaccine in Healthy Elderly Subjects and to Estimate the Incidence Rate of Medically-attended RSV Disease in Vaccine and Placebo Recipients
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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

Primary Outcome Measures :
  1. Immunogenicity as assessed by serum IgG antibody titers specific for the F-Protein antigen [ Time Frame: Day 0 to Day 364 ]

    Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/ calculated endpoints based on these data will include:

    • Geometric mean concentrations as EU (GMEU)
    • Geometric mean ratio (GMR)
    • Geometric mean fold-rise( GMFR)
    • Seroresponse rate (SRR)

  2. Number and percentage of subjects with respiratory illness associated with RSV [ Time Frame: Day 0 to Day 364 ]
    Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.

  3. Numbers and percentages of subjects with solicited local and systemic AEs. [ Time Frame: Day 0 to Day 364 ]
    Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters over 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.

Secondary Outcome Measures :
  1. Palivizumab competitive antibody responses based on antibody titers in competitive ELISA. [ Time Frame: Day 0 to Day 182 ]
    Summarized by geometric mean titer (GMT), GMR. GMFR, and SRR; as well as seroconversion rate (SCR).

  2. Neutralizing antibody titer to at least one prototypical RSV/A and one RSV/B virus strain. [ Time Frame: Day 0 to Day 182 ]
    Analyzed by GMT,GMR, SCR, and SRR. Neutralizing antibody assays, because of their time intensive nature, will be performed at a selected subset of time-points.

  3. Hemagglutination-inhibiting (HAI) antibody titers specific for the viruses in the 2014-15 vaccine at Day 28. [ Time Frame: Day 0 to Day 28 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  1. Males and females ≥60 years of age who are ambulatory and live in the community or in residential facilities which 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 serious adverse events (SAEs) within two months, and
    • Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the investigator.
  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 within 6 weeks of any prior influenza immunization.
  3. Received any vaccine other than an inactivated influenza vaccine in the 4 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 disturbance of coagulation.
  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 identifier (NCT number): NCT02266628

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United States, California
Nothern California Clinical Research
Redding, California, United States, 96001
United States, Georgia
Clinical Research Atlanta
Stockbridge, Georgia, United States, 30281
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Ohio
Rapid Medical Research
Cleveland, Ohio, United States, 44122
United States, Tennessee
Clinical Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Washington
Lisa Jackson
Seattle, Washington, United States, 98101
United States, Wisconsin
Marshfield Clinical Research Foundation
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
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Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
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Responsible Party: Novavax Identifier: NCT02266628    
Other Study ID Numbers: RSV-E-201
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No