Clinical Trial: A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP)

Brief Summary:

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups.

Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.


Detailed Summary:
Sponsor: Novavax

Current Primary Outcome:

  • Assessment of Safety [ Time Frame: Day 0 to Day 384 ]

    Number (and percentages) of subjects with 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 35 days post-first injection.

    Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for one year post-second injection.

  • Immunogenicity as assessed by hemagglutination-inhibiting (HAI) antibody titers against the vaccine-homologous A/Anhui/1/13 (H7N9) virus. [ Time Frame: Day 0 to Day 384 ]
    • Geometric mean titer (GMT)
    • Geometric mean ratio (GMR)
    • Seroconversion rate (SCR)
    • Seroresponse rate (SRR)


Original Primary Outcome: Same as current

Current Secondary Outcome: Immunogenicity as assessed by neuraminidase-inhibiting antibodies to N9. [ Time Frame: Day 0 to Day 384 ]

Original Secondary Outcome: Same as current

Information By: Novavax

Dates:
Date Received: July 9, 2013
Date Started: July 2013
Date Completion:
Last Updated: October 10, 2014
Last Verified: October 2014