Seasonal Influenza Clinical Trial
Official title:
A Phase 2 Study to Assess the Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).
The study will be conducted in two parts (A & B) at a single center in Mexico. The purpose
of Part A is to evaluate the safety of the H1N1 VLP vaccine and to evaluate immunogenicity
and select a dose for Part B. In Part A, 1,000 subjects will be enrolled and randomized to a
1:1:1:1 schedule (5µg, 15µg and 45µg doses of H1N1 VLP vaccine or placebo. Subjects will
receive two intramuscular (IM) injections (0.5mL/dose) of the H1N1 VLP vaccine or placebo 21
days apart. Blood for HAI assays will be collected at 3 time points (baseline, Day 14 and
Day 36). Subjects will be followed for all adverse events (AEs) from the first day of the
study through 21 days after the second dose (Day 36). Subjects will be followed for serious
AEs and significant new medical conditions (SNMCs) to the end of the study 6 months
post-dose 2 (Day 194).
Once the first 500 subjects are enrolled into Part A, enrollment will be halted until 3 days
of safety follow-up data are reviewed by the study Data and Safety Monitoring Board (DSMB).
A second data review will occur following Day 14 visit for Part A to select the dose to be
administered in Part B.
Part B of the study will be conducted to evaluate safety and accumulate enough safety data
to potentially move forward with broader use of the vaccine assuming favorable results. In
Part B, a total of 3,250 - 3,750 subjects will be randomized to receive the selected dose of
H1N1 VLP vaccine or placebo. A total of 3,000 H1N1 VLP vaccine recipients at the selected
dose or higher, and 1,250 placebo recipients will be enrolled in Parts A and B. Following
completion of Day 36 in Part A, data may be reviewed to assess 1 injection vs. 2 injections
in Part B.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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