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Trial record 1 of 1 for:    NCT02593071
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Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.

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ClinicalTrials.gov Identifier: NCT02593071
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Novavax

October 22, 2015
October 30, 2015
June 6, 2017
October 2015
November 2016   (Final data collection date for primary outcome measure)
  • Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. [ Time Frame: Day 0 to Day 364 ]

    Derived/calculated endpoints based on these data will include:

    • Geometric mean concentration as EU (GMEU)
    • Geometric mean ratio (GMR)
    • Seroresponse rate (SRR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
  • 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, over 56 days post-dosing (Year 2). In addition, MAEs, SAEs, and SNMCs will be collected for 1 year (approximately 364 days) post-dosing
Same as current
Complete list of historical versions of study NCT02593071 on ClinicalTrials.gov Archive Site
  • Palivizumab-competitive antibody (PCA) expressed as µg/mL as detected in a competitive ELISA [ Time Frame: Day 0 to Day 182 ]

    Summarized by:

    • Geometric mean concentrations (GMC)
    • Geometric mean ratio (GMR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
  • Neutralizing antibody titer to at least one RSV/A and one RSV/B strain. [ Time Frame: Day 0 to Day 182 ]

    Summarized by:

    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
Same as current
  • Number and percentages of subjects fulfilling the definitions of RSV-associated respiratory disease and/or RSV-lower respiratory tract disease in various treatment groups. [ Time Frame: Day 0 to Day 182 ]
  • Number and percentages of subjects with respiratory illnesses for which a non-RSV viral respiratory pathogen (with or without concurrent RSV infection) is identified by RT-PCR. [ Time Frame: Day 0 to Day 182 ]
Same as current
 
Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year.
A Phase II Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) Recombinant F Nanoparticle Vaccine in Healthy Older Adult Subjects Previously Treated With the Same Vaccine, or Placebo, in the Prior Year; and to Estimate the Incidence Rate of RSV Disease and Vaccine Efficacy in Subjects Based on Their RSV F Vaccine Experience Over Two Consecutive Years.
This study will enroll subjects who received the RSV F vaccine or placebo in the earlier study (RSV-E-201, Year 1) and re-randomize them to receive either vaccine or placebo in a second season. This design will permit evaluation of the safety and immunogenicity of revaccination in a second RSV season, and the safety and immunogenicity of revaccination over two years.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Respiratory Syncytial Virus (RSV)
  • Biological: RSV-F Vaccine
  • Biological: Phosphate Buffer Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1330
1600
November 2016
November 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males and females ≥60 years of age who are veterans of the RSV-E-201 clinical trial and 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 SAEs within two months, and
    • Absence of known, current, life-limiting diagnoses that, in the opinion of the investigator, render survival to trial completion 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. The investigator may use his/her discretion to assess potential ability and willingness to comply based on performance in the prior trial, RSV-E-201.
  4. Access to inbound and outbound communication by telephone with caregivers and study staff.

Exclusion Criteria:

  1. Participation in research involving investigational product (drug / biologic / device) within 45 days before planned date of first vaccination, with the exception of participation in the preceding study RSV-E-201.
  2. History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome (GBS) within 6 weeks of any prior influenza immunization, or withdrawal from the preceding RSV-E-201 clinical trial due to an adverse event deemed test article-related or at the advice of the investigator.
  3. Receipt of any vaccine other than IIV in the 4 weeks preceding the study vaccination; or any RSV vaccine at any time unless administered in the preceding study, RSV-E-201.
  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. 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).
Sexes Eligible for Study: All
60 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02593071
RSV-E-202
No
Not Provided
Not Provided
Novavax
Novavax
Not Provided
Study Director: D. Nigel Thomas, Ph.D. Novavax, Inc.
Novavax
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP