A/H5N1in Adult - Aventis
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to compare how the body reacts to different strengths
      of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a
      subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm.
      Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or
      a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine
      pregnancy test for women, and blood samples. Participants will be asked to complete a diary
      to record temperatures, medications taken, and side effects from the vaccine. Volunteers will
      be involved with study procedures for approximately 7 months. The study will enroll about
      450-470 healthy participants, ages 18-64.
    

Detailed description: 
      Approximately 450 healthy adults, 18 to 64 years old, inclusive, will be enrolled into this
      multicenter, randomized, double-blinded, placebo-controlled, dose-ranging clinical trial. The
      study will be conducted in 2 stages. During Stage I, 113 subjects who meet the entry criteria
      for the study will be randomized to receive saline placebo, or 7.5, 15, 45, or 90 mcg of the
      influenza A/H5N1 vaccine by intramuscular injection in an approximate 1:2:2:2:2 ratio
      (N=25/vaccine dose group and 13 in the placebo group). Subjects will receive 2 doses
      separated by approximately 28 days. Vaccine administration will be performed by an unblinded
      vaccine administrator, who will not be involved in subsequent assessments. Subjects will be
      observed in the clinic for 15 to 30 minutes after inoculation, and subjects will maintain a
      memory aid to record oral temperature and systemic and local AEs for 7 days after each
      immunization. Subjects will be contacted by telephone on Day 2 after each immunization to
      assess for the occurrence of AEs, and they will return on Day 7 for AE and concomitant
      medication assessment, a targeted physical examination (if indicated), and review of the
      memory aid. Serum for immunogenicity evaluations will be obtained prior to the first
      vaccination (ie, at screening for Stage I and Day 0 for Stage II), prior to the second
      vaccination, at Day 28, and on Days 56 and 208. All available 7-day safety data following the
      first dose of vaccine on the 113 subjects enrolled in Stage I will be reviewed by the Safety
      Monitoring Committee (SMC) prior to enrollment of the remaining subjects (Stage II), who will
      be followed according to the same protocol. All available 7-day safety data following the
      second dose of vaccine on the subjects enrolled in Stage I also will be reviewed by the SMC
      prior to administering the second dose of vaccine to the subjects in Stage II. This study is
      linked to DMID protocols 07-0022, 05-0006, 05-0090 and 08-0059.
    

Intervention name(s): Influenza A/H5N1 Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: A/H5N1, Influenza, Vaccine, parent protocol