Sanofi Pasteur, TIV + H1N1, Pediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immune response (body's defense against
      disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study
      will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot
      to make it most effective. The 650 participants will be divided into the following age
      groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents
      10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each
      age level. Study procedures include: medical history, targeted physical exam based on
      history, maintaining a memory aid, and blood sample collection. Participants will be involved
      in the study for about 8 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 (WHO) 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. In addition, 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. If the novel influenza H1N1
      2009 virus continues to circulate, it is possible that it will co-circulate with the
      non-pandemic seasonal influenza strains. In this situation, it might be beneficial to
      co-administer an H1N1 vaccine concurrent with the seasonal inactivated influenza vaccine.
      This protocol will explore if vaccination with the 2009-2010 licensed seasonal trivalent
      influenza vaccine (TIV) has an effect on antibody response to the novel influenza H1N1 2009
      virus. This protocol will also examine if receiving the H1N1 vaccine either concurrent with,
      prior to, or following the seasonal influenza vaccine affects the antibody response to the
      seasonal influenza vaccine. A randomized Phase II study in infants, toddlers, children and
      adolescents. This study is designed to investigate the safety, reactogenicity, and
      immunogenicity of an inactivated influenza H1N1 virus vaccine when given concurrent with
      seasonal TIV, or sequentially with (before or after) seasonal influenza vaccine. Primary
      objectives are: safety, to assess the safety of the unadjuvanted, inactivated H1N1 vaccine
      when administered either concurrent with, prior to, or following licensed seasonal influenza
      vaccination; and immunogenicity, to assess the effect of TIV administration on antibody
      response to unadjuvanted, inactivated H1N1 vaccine as assessed by HAI, stratified by age of
      recipient. The secondary objective is: immunogenicity, to assess the effect of H1N1 vaccine
      administration on antibody response to TIV as assessed by HAI, stratified by age of
      recipient. Subjects will be randomized into 4 groups, stratified by age (150 subjects per
      group with 50 subjects per age stratum: greater than or equal to 6-<36 months, greater than
      or equal to 36 months-9 years, and 10-17 years), to receive two 15 mcg doses of inactivated
      influenza H1N1 vaccine at Days 0 and 21 followed by TIV on Day 42 (Group 1), two 15 mcg doses
      of H1N1 vaccine of which the first dose is administered concurrently with TIV (Group 2), two
      15 mcg doses of H1N1 vaccine of which the second dose is administered concurrently with TIV
      (Group 3), or TIV administered on Day 0 followed by two 15 mcg doses of H1N1 vaccine on Days
      21 and 42 (Group 4). Following immunization, safety will be measured by assessment of adverse
      events for 21 days following the last vaccination (Day 42 for those who do not receive the
      second dose), serious adverse events and new-onset chronic medical conditions for 8 months
      post first vaccination (Day 201 for Groups 2 and 3 or Day 222 for Groups 1 and 4), and
      reactogenicity to the vaccines for 8 days following each vaccination (Day 0-7).
      Immunogenicity testing will include HAI and neutralizing antibody testing prior to
      vaccination, on the day of each vaccination (Days 0, 21 and 42) and 21 days following the
      third vaccine.
    

Intervention name(s): Inactivated H1N1 Vaccine; Trivalent Inactivated Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated influenza H1N1 vaccine, 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm or in the anterolateral thigh muscle (1 injection in each arm or each thigh if receiving 2 doses).; Licensed seasonal trivalent influenza vaccine (TIV) (2009-2010 season). For subjects greater than or equal to 6 - <36 months, licensed TIV will be administered as a single 0.25 mL intramuscular (IM) injection in the deltoid muscle of the arm or in the anterolateral thigh muscle. For subjects greater than or equal to 36 months - 17 years, licensed TIV will be administered as a single 0.5 mL IM injection in the deltoid muscle of the arm or in the anterolateral thigh muscle.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H1N1, influenza A viruses, TIV, vaccine, infants, children