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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus (RSV)
• Intervention / Treatment: Biological: RSV-F Vaccine; Biological: Phosphate Buffer Placebo

• Study Type: Interventional
• Enrollment (Actual): 11850
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers and percentages of subjects with moderate-severe RSV-LRTD	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.	Day 0 to Day 182
Numbers and percentages of subjects with solicited local and systemic AEs	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.	Day 0 to Day 364

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers and percentages of subjects with RSV-Acute Respiratory Disease (RSV-ARD)	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.	Day 0 to Day 182
RSV F protein antibody expressed as ELISA Units (EU).	Summarized by: Geometric Mean Concentrations as EU (GMEU); Geometric Mean Ratio (GMR); Seroresponse Rate (SRR)	Day 0 to Day 364
Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA	Summarized by: Geometric Mean Concentrations as EU (GMEU); Geometric Mean Fold Rise (GMFR)	Day 0 to Day 364
Neutralizing antibody titer to at least one RSV/A and one RSV/B virus strain	Summarized by: Geometric Mean Titer (GMT); Geometric Mean Ratio (GMR)	Day 0 to Day 28
Number and percentage of subjects with RSV-ARD and/or RSV-LRTD	Summarized by treatment group and by age strata and in strata defined by comorbidities and type of community housing.	Day 0 to Day 364
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.		Day 0 to Day 28

Collaborators and Investigators

• Sponsor: Novavax

Publications and helpful links

Helpful Links

• Novavax Webpage

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RSV-E-301