Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II open-label study in approximately 240, and up to 400, healthy males and
      non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety,
      reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21
      days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine
      manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100
      subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately
      60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly
      as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100
      subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as
      7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject
      will be approximately 7 months.
    

Detailed description: 
      This is a Phase II open-label study in approximately 240 (up to 400) healthy males and
      non-pregnant females, 6 months to 17 years old, inclusive. This study is designed to assess
      the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly
      approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza
      H3N2 variant (H3N2v) vaccine (MIV) manufactured by sanofi pasteur. Subjects will be
      stratified by age (approximately 120 (up to 200) subjects 6-35 months old, approximately 60
      (up to 100) subjects 3-8 years old, and approximately 60 (up to 100) subjects 9-17 years
      old). Subjects in the 6-35 months old cohort will be randomized to receive either two doses
      of H3N2v MIV, administered intramuscularly as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25
      milliliter (mL) dose (approximately 60 (up to 100) subjects), approximately 21 days apart, or
      two doses of H3N2v MIV, administered intramuscularly as 15mcg HA/0.5mL dose (approximately 60
      (up to 100) subjects), approximately 21 days apart. All subjects in the 3-8 years old cohort
      and 9-17 years old cohort will receive two doses of H3N2v MIV, delivered intramuscularly as
      15mcg HA/0.5mL dose, approximately 21 days apart. Subjects may receive licensed seasonal
      influenza vaccine prior to (>2 weeks if given the inactivated vaccine or >4 weeks if given
      the live, attenuated vaccine) the first H3N2v vaccination. Alternatively, subjects may
      receive licensed seasonal influenza vaccine at any time after completion of Visit 05 or
      following an early termination visit. Safety will be measured by the occurrence of solicited
      injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7
      days after each H3N2v vaccination. Unsolicited non-serious adverse events (AEs) will be
      collected from the time of the H3N2V vaccination (Day 0 (Visit 01)) through approximately 21
      days after the last H3N2v vaccination (approximately Day 42 (Visit 05) for subjects who
      receive two H3N2v vaccinations; approximately Day 21 (Visit 03) for subjects who receive only
      one H3N2v vaccination). After approximately 21 days after the last H3N2v vaccination,
      non-serious AEs will be limited to new-onset chronic medical conditions, which will be
      documented through approximately 7 months after the first H3N2v vaccination (Visit 08).
      Serious adverse events (SAEs) will be collected from the time of the first H3N2v vaccination
      (Day 0 (Visit 01)) through approximately 7 months after the first H3N2v vaccination (Visit
      08). Immunogenicity testing will include performing hemagglutination inhibition (HAI) and
      neutralizing (Neut) antibody assays on serum obtained prior to each H3N2v vaccination (Day 0
      (Visit 01) and approximately Day 21 (Visit03)) and approximately 21 days after the second
      H3N2v vaccination (Visit 05).
    

Intervention name(s): Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203
Intervention type(s): Biological
Intervention description(s): A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: children; H3N2; H3N2v; influenza; pediatric; unadjuvanted; vaccine