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

Respiratory Syncytial Virus (RSV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608502
• Other study ID #: RSV-E-301
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2022
• Source: Novavax
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11850
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Respiratory Syncytial Virus (RSV)

Intervention

Biological:
• RSV-F Vaccine

• Phosphate Buffer Placebo

Locations

Country	Name	City	State
United States	Research Site US005	Anaheim	California
United States	Research Site US047	Austin	Texas
United States	Research Site US066	Binghamton	New York
United States	Research Site US062	Birmingham	Alabama
United States	Research Site US012	Boise	Idaho
United States	Research Site US074	Bristol	Tennessee
United States	Research Site US078	Cary	North Carolina
United States	Research Site US070	Charleston	South Carolina
United States	Research Site US069	Chicago	Illinois
United States	Research Site US081	Cincinnati	Ohio
United States	Research Site US085	Cincinnati	Ohio
United States	Research Site US030	Cleveland	Ohio
United States	Research Site US050	Dakota Dunes	South Dakota
United States	Research Site US010	Dallas	Texas
United States	Research Site US020	Durham	North Carolina
United States	Research Site US072	Edina	Minnesota
United States	Research Site US017	Endwell	New York
United States	Research Site US060	Fort Worth	Texas
United States	Research Site US083	Fort Worth	Texas
United States	Research Site US019	Houston	Texas
United States	Research Site US051	Kansas City	Missouri
United States	Research Site US077	Knoxville	Tennessee
United States	Research Site US057	Las Vegas	Nevada
United States	Research Site US003	Lenexa	Kansas
United States	Research Site US080	Lexington	Kentucky
United States	Research Site US024	Marshfield	Wisconsin
United States	Research Site US046	Mesa	Arizona
United States	Research Site US039	Metairie	Louisiana
United States	Research Site US068	Metairie	Louisiana
United States	Research Site US055	Methuen	Massachusetts
United States	Research Site US061	Mobile	Alabama
United States	Research Site US056	Mount Pleasant	South Carolina
United States	Research Site US079	Mount Pleasant	South Carolina
United States	Research Site US029	Nashville	Tennessee
United States	Research Site US059	Newington	New Hampshire
United States	Research Site US052	Newton	Kansas
United States	Research Site US025	Norfolk	Nebraska
United States	Research Site US067	Norfolk	Virginia
United States	Research Site US053	Oklahoma City	Oklahoma
United States	Research Site US018	Omaha	Nebraska
United States	Research Site US065	Peoria	Illinois
United States	Research Site US054	Phoenix	Arizona
United States	Research Site US028	Redding	California
United States	Research Site US049	Rochester	New York
United States	Research Site US076	Saint Louis	Missouri
United States	Research Site US008	Salt Lake City	Utah
United States	Research Site US075	Salt Lake City	Utah
United States	Research Site US082	Salt Lake City	Utah
United States	Research Site US084	San Angelo	Texas
United States	Research Site US064	San Diego	California
United States	Research Site US045	Savannah	Georgia
United States	Research Site US026	Seattle	Washington
United States	Research Site US013	Stockbridge	Georgia
United States	Research Site US048	Tempe	Arizona
United States	Research Site US073	Tomball	Texas
United States	Research Site US044	Warwick	Rhode Island
United States	Research Site US027	West Jordan	Utah
United States	Research Site US058	Wichita	Kansas
United States	Research Site US071	Wilmington	North Carolina
United States	Research Site US063	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Novavax Webpage