Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
627
Comparison of different dosages of vaccines
51, Northern California Clinical Research Center
Redding, California, United States
47, Benchmark Research
Sacramento, California, United States
46, Johnson County Clinical Trials
Lenexa, Kansas, United States
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to \<9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to \<18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to \< 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.
Time frame: Day 1 through Day 7 after each vaccination
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.
The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.
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49, Heartland Research Associates, LLC
Wichita, Kansas, United States
43, Central Kentucky Research Associates
Lexington, Kentucky, United States
41, Benchmark Research
Metairie, Louisiana, United States
44, Rochester Clinical Research Inc.
Rochester, New York, United States
50, PMG Research of Raleigh
Raleight, North Carolina, United States
45, Omega Medical Research
Warwick, Rhode Island, United States
42, Research Acros
Dallas, Texas, United States
...and 1 more locations
Time frame: Day 1 through Day 366
Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Time frame: Day 22, Day 43 post vaccination
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.
Time frame: Day 1, Day 22, Day 43 post vaccination
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).
The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.
Time frame: Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination
Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.
Time frame: Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1
Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.
Time frame: Day 183 and Day 366 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years. Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer \<1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.
Time frame: Day 22, Day 43 post vaccination
Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.
The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.
Time frame: Day 1, Day 22, Day 43 post vaccination
GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.
GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.
Time frame: Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1