Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and the body's immune response (body's
      defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy
      volunteers from three age groups (greater than or equal to 6 months to less than 36 months,
      greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of
      influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate.
      Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups.
      Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants
      will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures
      include: medical history, physical exam, maintaining a memory aid, and blood sample
      collection. Participants will be involved in study related procedures for approximately 7
      months.
    

Detailed description: 
      Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause
      of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many
      countries around the world, prompting the World Health Organization to declare a pandemic on
      June 11, 2009. Data from several cohorts in different age groups that received licensed
      trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide
      protection against the new virus. Adults are more likely to have measurable levels of serum
      hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. These
      data indicate the need to develop vaccines against the new H1N1 strain and suggest that
      different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate
      for persons in different age groups. Based on clinical data from other novel influenza A
      viruses, a higher dose, or multiple doses of an unadjuvanted, inactivated influenza H1N1
      vaccine may be necessary to confer protection to a maximal number of vaccine recipients. This
      protocol explores the antibody response following vaccination at 2 different dosage levels
      (15 mcg and 30 mcg) in up to 650 children aged 6 months to 17 years, inclusive. This study
      assesses the immune response following a single dose of vaccine, to assess whether
      individuals have any pre-existing 'prime' immunity, such that the initial H1N1 vaccination
      serves as a boost, thus conferring a more rapid time to protection and the need for fewer
      doses. Antibody responses will be assessed after a second dose. This is a randomized,
      double-blinded, Phase II study in healthy infants, toddlers, children, and adolescents and is
      designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated
      influenza H1N1 virus vaccine. The primary objectives are safety, to assess the safety of the
      unadjuvanted, inactivated influenza H1N1 vaccine when administered at the 15 mcg or 30 mcg
      dose; and immunogenicity, to assess the antibody response following a single dose of
      unadjuvanted, inactivated influenza H1N1 vaccine, stratified by age of recipient, when
      administered at the 15 mcg or 30 mcg dose. The secondary immunogenicity objective is to
      assess the antibody response following two doses of unadjuvanted, inactivated influenza H1N1
      vaccine, stratified by age of recipient, when administered at the 15 mcg or 30 mcg dose.
      There will be 3 age strata, each containing 200 subjects: greater than or equal to 6 months
      to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years .
      Subjects will be randomized into 2 groups, with 300 subjects per group (100 per strata), to
      receive intramuscular inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group
      2). The vaccine will be administered on Days 0 and 21. Following immunization, safety will be
      measured by assessment of adverse events (AEs) for 21 days following the last vaccination
      (Day 42 for those receiving both doses and Day 21 for those who do not receive the second
      dose); serious adverse events (SAEs) and new-onset chronic medical conditions through 7
      months post first vaccination (Day 201); and reactogenicity to the vaccines for 8 days
      following each vaccination (Day 0-7). Immunogenicity testing will include HAI and
      neutralizing antibody testing on serum obtained on the day of each vaccination (prior to
      vaccination) and 21 days following the second vaccination (Day 42). For subjects aged 10-17
      years, serum for antibody assays will also be obtained at Day 8-10 following each
      vaccination. However, for the greater than or equal to 6 months - less than 36 months and the
      greater than o
    

Intervention name(s): Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Intervention type(s): Biological
Intervention description(s): Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral thigh muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: H1N1, influenza A viruses, vaccine, infants, children