Safety and immunological effect of domestic split influenza virus vaccine.
- Author:
Pei-Ru ZHANG
1
;
Xiao-Ping ZHU
;
Liang-Jun ZHOU
;
You-Quan LIU
;
Ya FAN
;
Guo CHEN
;
Zhi CHEN
;
Yan LIU
;
Hong-Ying SUN
;
Jian-Lin WU
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Child; Humans; Influenza A Virus, H1N1 Subtype; immunology; Influenza A Virus, H3N2 Subtype; immunology; Influenza Vaccines; adverse effects; immunology; Influenza, Human; prevention & control; Middle Aged; Young Adult
- From: Chinese Journal of Preventive Medicine 2009;43(7):615-618
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the safety and immunological effect of domestic split influenza virus vaccine.
METHODSAll 606 subjects were divided into three groups by under 6, 16-60 and above 60 years old. Each age group was divided as study group (n = 213), control group 1 (n = 195) and control group 2 (n= 198) by Table of Random Number, one domestic vaccine and two imported vaccines were respectively inoculated in three group people. The differences of clinical side effect rate, antibody positive rate, protective rate and geometric mean titer (GMT) of these three vaccines were compared by using the statistical software with statistical significance of P < 0.05.
RESULTSThe side effect rate of study group, control group 1 and control group 2 was 3.76% (8/213), 4.10% (8/195), and 3.54% (7/198), respectively without statistical significance(chi2 = 0.87, P =0.93). The positive seroconversion rates of H1N1, H3N2 and B in these three groups were respectively 89.2% (190/213), 63.4% (135/213), 86.4% (184/213), 88.7% (173/195), 61.5% (120/195), 87.2% (170/195), 87.9% (174/198), 61.6% (122/198) and 84.8% (168/198). There were no statistical significance in the total positive seroconversion rate of each antibody type (chi2(H1N1) = 0.94, P(H1N1) = 0.63; chi2(H3N2) = 0.94, P(H3N2) = 0.63; chi2(B) = 0.75, P(B) = 0.69). The average growth multiple of H1N1, H3N2 and B in these three groups were 10.7, 7.3, 8.4, 10.5, 6.3, 8.3, 10.2, 7.1, 8.8 times. There were no statistical significances in the GMT growth multiple of each antibody type (F(H1N1) = 0.35, P(H1N1) = 0.70; F(H3N2) = 2.22, P(H3N2) = 0.11; F(B) = 1.51, P(B) = 0.35). The antibody protective rates of H1N1, H3N2 and B were 100% (213/213), 70.0% (149/213), 95.3% (203/213), 100% (195/195), 66.7% (130/195), 97.9% (191/195), 99.5% (197/198), 66.2% (131/198), 96.5% (191/198) respectively. There was no statistical difference among the three vaccines (chi2(H1N1) = 2.04, P(H1N1) = 0.36; chi2(H3N2) = 0.74, P(H3N2) = 0.69; chi2(B) = 0.42, P(B) = 0.82).
CONCLUSIONThe domestic influenza split vaccine might be suitable for colony vaccination for its having clinical safety and immunological effect.
