Influenza A (H1N1) Vaccine, (Split, Inactivated)

Influenza A (H1N1) Vaccine, (Split, Inactivated) Influenza A (H1N1) Vaccine, (Split, Inactivated) H1N1 Influenza A Vaccine (Split Virion), Inactivated is indicated for active immunization of vulnerable individuals 3 years of age and older. 0.5mL/vial 0.5mL/ syringe Influenza A (H1N1) Vaccine, (Split, Inactivated) Clinical trial report of H1N1 Influenza A Vaccine (Split Virion) manufactured by Hualan, A novel influenza A(H1N1)vaccine in various age groups, was published on the New England Journal of Medicine (NEJM) (Volume 361) on Oct. 21, 2009. The trial adopted the design of randomization, placebo-control and double blinding to evaluate the safety and immunogenicity of the vaccine. Clinical trial Summarize results of clinical trials finished by 10 manufacturers in China. Analyze data of 9562 subjects (3~ 87 years old) in 15µg and 30µg experimental groups and placebo control groups. For the safety data after administering one single dose of the vaccine, refer to the table 1 below; and for the immunogenicity results, refer to the table 2 below. Table 1: Adverse reaction incidence after administration of H1N1 Influenza A Vaccine (Split Virion), Inactivated Dose Group 15μg Sum of Group 15μg & Group 30μg Placebo group Test Numbers (N) 4520 8069 1493 Total incidence n (%) 703(15.55) 1404(17.40) 164(10.98) Class 1 610(13.50) 1157(14.34) 146(9.78) Class 2 79(1.75) 210(2.60) 17(1.14) Class 3 14(0.31) 37(0.46) 1(0.07) Local incidence n (%) 170(3.76) 363(4.49) 23(1.54) Pain 147(3.25) 313(3.88) 18(1.21) Pruritus 16(0.35) 38(0.47) 4(0.27) Redness 15(0.33) 29(0.36) 2(0.13) Swelling 9(0.20) 26(0.32) 0(0.00) Induration 6(0.13) 22(0.27) 0(0.00) Maculopapule(injection site) 2(0.04) 6(0.07) 0(0.00) Systemic incidence n (%) 583(12.90) 1164(14.43) 144(9.65) Fever 464(10.27) 918(11.38) 110(7.37) Headache 57(1.26) 127(1.57) 20(1.34) Fatigue 53(1.17) 123(1.52) 15(1.00) Cough 26(0.58) 60(0.74) 6(0.40) Diarrhea 25(0.55) 46(0.57) 6(0.40) Nausea and vomiting 16(0.35) 33(0.41) 5(0.33) Myalgia 11(0.24) 40(0.50) 5(0.33) Urticaria 3(0.07) 15(0.19) 2(0.13) Other incidence n (%) 21(0.46) 38(0.47) 5(0.33) Note: placebo group mostly were 18~59 years old, for representative sample size and crowd are not comparable, comparison of vaccine and placebo should be taken careful. Table 2: Antibody response of 15µg H1N1 Influenza A Vaccine (Split Virion), Inactivated before and post vaccination (Day 21) Time Indicator 3~11 Years 12~17 Years 18~59 Years Years ≥ 60 Total Before immunization Subjects (N) 1143 1108 1178 999 4428 GMT 5.28 6.94 6.27 6.20 6.14 Protection Rate % 0.96 6.14 2.97 3.30 3.32 Day 21 post immunization GMT 82.06 473.40 329.17 150.21 211.02 GMT Increasing Rate 15.54 68.26 52.49 24.23 34.39 Seroconversion %(95%CI) 79.44 (76.98~81.75) 93.86 (92.28~95.20) 92.95 (91.34~94.35) 80.98 (78.41~83.37) 86.99 (85.97~87.97) Protection Rate %(95%CI) 79.62 (77.16~81.92) 95.22 (93.79~96.40) 93.72 (92.18~95.04) 82.38 (79.88~84.70) 87.90 (86.90~88.84) Note: The fold increase of GMT was the rate of the comparison.(after/before vaccination) Influenza A (H1N1) Vaccine, (Split, Inactivated) Hualan Biological Engineering Inc Tel:+86-373-3559991 Add:Jia No.1, Hualan Ave., Xinxiang, Henan Province, P.R.China