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

• ClinicalTrials.gov Identifier: NCT02608502
• Recruitment Status: Completed
• First Posted: November 18, 2015
• Last Update Posted: July 19, 2022
• Sponsor: Novavax
• Information provided by (Responsible Party): Novavax

Tracking Information

• First Submitted Date: November 10, 2015
• First Posted Date: November 18, 2015
• Last Update Posted Date: July 19, 2022
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 17, 2015)

• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 17, 2015)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus (RSV)

Intervention

• Biological: RSV-F Vaccine
• Biological: Phosphate Buffer Placebo

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 17, 2015): 11850
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02608502
• Other Study ID Numbers: RSV-E-301
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Novavax
• Original Responsible Party: Same as current
• Current Study Sponsor: Novavax
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Development; Novavax, Inc.

• PRS Account: Novavax
• Verification Date: July 2022