This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,719
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Miami Research Associates
Miami, Florida, United States
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Geometric mean hemagglutinin inhibition (HI) titer = GMT
Time frame: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
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Johnson County Clin-Trials
Lenexa, Kansas, United States
Meridien Clinical Research
Omaha, Nebraska, United States
Regional Clinical Research
Endwell, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Triangle Medical Research Associates
Cary, North Carolina, United States
Triangle Medical Research Associates
Raleigh, North Carolina, United States
Carolina Medical Trials
Winston-Salem, North Carolina, United States
Prestige Clinical Research
Franklin, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
...and 11 more locations
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer \<1:10 and a post vaccination HI titer \> 40 or a pre-vaccination HI titer \> 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
Time frame: 21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
Time frame: 21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
Time frame: 7 days after vaccination