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Category:Bio Products > Sera and Vaccines > Vaccine
Product Name:Hualan bio Influenza A (H1N1) Vaccine, (Split, Inactivated)by Hualan biological
Price(USD):0.00
Company:Hualan Biological Vaccine Inc.
Factory Location: Xinxiang, Henan, China
Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East,Africa
Contract Manufacturing: CRO,CMO
Packaging Information: penicillin bottle
Delivery Lead Time: 1 MONTH
Sample Provided: yes
Payment Terms: LC/TT
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)
Tel：+86-373-3559991
E-mail：hualan@hualanbio.com
Add：Jia No.1, Hualan Ave., Xinxiang, Henan Province, P.R.China
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