This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
784
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
San José, Costa Rica
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).
Time frame: Day 1 to day 387
Age Distribution at Baseline
Time frame: Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the the per-protocol set (PPS).
Time frame: Day 1 to day 387
HI GMR, in Adults 18 to 64 Years
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Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers). The analyses were performed on the Per-Protocol Set (PPS).
Time frame: Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer \>1:40 or a prevaccination HI titer \>1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the per-protocol set (PPS).
Time frame: 7 days and 21 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to \<9 years of age). Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
Time frame: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age). Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
Time frame: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age). Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination. The analyses were performed on the safety set.
Time frame: 7 days after each vaccination