Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Population Aged 3 Years and Older
Condition: Virus Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza; Orthomyxoviridae Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Orthomyxoviridae Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary safety objective of this study is to assess the safety of split- virion
      inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg
      dose. The primary immunogenicity objective is to assess the antibody response following each
      dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants
      will include up to 2200 healthy persons age 3 and older who have no history of novel
      influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized,
      double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and
      older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60
      years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be
      randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or
      non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4
      dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine
      of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1
      vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose
      or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza
      H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following
      immunization, safety will be measured by assessment of adverse events through 21 days
      following the last vaccination (Day 42 for those receiving both doses), serious adverse
      events and new-onset chronic medical conditions through 6 months post the final vaccination
      (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7)
      following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI)
      on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after
      first vaccination, and 21 days following the second vaccination (Day 42).
    

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. The primary safety
      objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine
      with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary
      immunogenicity objective is to assess the antibody response following each dose of split-
      virion inactivated A(H1N1) vaccine with and without adjuvant,. Participants will include up
      to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009
      infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded,
      Phase II study in healthy males and non-pregnant females, aged 3 years and older. This study
      is designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated
      influenza H1N1 virus vaccine at different dose levels of split- virion inactivated H1N1
      vaccine with or without adjuvant or placebo in 4 aged groups. Subjects will be stratified by
      elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and
      children (3-11 years), elders and adolescents will be randomized into 5 dose
      groups(adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of
      15 or 30 mcg per dose ) , children will be randomized into 4 dose groups(adjuvanted H1N1
      vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose ),
      adults will be randomized into 6 dose groups(adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per
      dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo ), 110 subjects per
      dose and age stratum will be to receive intramuscular influenza H1N1 vaccine . The H1N1
      vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be
      measured by assessment of adverse events through 21 days following the last vaccination (Day
      42 for those receiving both doses), serious adverse events and new-onset chronic medical
      conditions through 6 months post the final vaccination (Day 180 after second vaccination),
      and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination.
      Immunogenicity testing will be HAI on serum obtained on the day 21 of each vaccination (prior
      to vaccination), on Day 21 after first vaccination, and 21 days following the second
      vaccination (Day 42).
    

Intervention name(s): split-virion, non-adjuvanted H1N1 vaccine of 30 μg; Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg; Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg; Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg; Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Placebo Comparator: Placebo control
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.; 440 participants (110 elders,110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.; 440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.; 330 participants (110 elders, 110 adults, and 110 adolescents) to receive split-virion, adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.; 440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.; 110 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flu; adjuvanted H1N1 vaccine; non-adjuvanted H1N1 vaccine; Immunogenictiy; Safety