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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Enrollment
270
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.
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, United States
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, United States
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, United States
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, United States
Duke Health Center at Roxboro
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, United States
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, United States
Occurrence of H3N2v MIV-related serious adverse events from the time of the first H3N2v vaccination through approximately 7 months after the first H3N2v vaccination.
Time frame: First vaccination (Day 0) through 7 months.
Occurrence of solicited injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7 days after each H3N2v vaccination.
Time frame: Through 7 days after each H3N2v vaccination.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 year old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and minimum 4 fold rise in post-vacc. HAI antibody titer) following first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
Geometric Mean Titers of serum HAI and Neut antibody following receipt of each dose of H3N2v.
Time frame: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of the first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, baseline and approximately 21 days. 9-17 years old cohort, baseline and approximately 42 days.
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of each dose of H3N2v MIV.
Time frame: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and a minimum 4 fold rise in post-vacc. HAI antibody titer)following first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, approximately 21 days. 9-17 years old cohort, approximately 42 days.
Percentage of subjects achieving seroconversion (either pre-vacc. Neut titer < 1:10 and post-vacc. Neut titer >/=1:40 or pre-vacc. Neut titer >/=1:10 and minimum 4 fold rise in post-vacc. Neut antibody titer) following receipt of each dose of H3N2v MIV.
Time frame: Approximately 21 days following receipt of each dose.
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