The clincal safety of the split influenza vaccine Anflu in infants and children
10.3321/j.issn:0253-9624.2008.z1.031
- VernacularTitle:流行性感冒裂解疫苗安尔来福在婴幼儿及儿童中应用的安全性观察
- Author:
Cheng-Hao SU
1
;
Shan-Shan MA
;
Shui-Chun LIN
;
Mo-Xiu WU
;
Yan LIU
;
Yan-Wei ZHAO
Author Information
1. 厦门市疾病预防控制中心
- Keywords:
Influenza vaccines;
Safety;
Evaluation studies
- From:
Chinese Journal of Preventive Medicine
2008;42(z1):138-140
- CountryChina
- Language:Chinese
-
Abstract:
Objective To further evaluate the safety and observe for unknown adverse reactions in the prelicensure trials of Anflu(split influenza virus vaccine)in children aged 6 months to 3 years old and 3 to 11 years old respectively.Methods This open clinical trial enrolled 100 healthy children in each of the two groups:6 months to 3 years old group and 3 to 11 years old group.The 6 months to 3 years group were vaccinated with two pediatric doses(0.25 ml/dose),28 days apart.The 3 to 11 years group were vaccinated with one adult dose(0.5 ml/dose).All the subjects were observed for 30 min after vaccination and had 3 follow-up visits at 24,48,72 h after vaccination. All subjects with adverse reactions were followed up till the symptoms resolved.Results The total adverse reaction rate was 6.0%(12/200).The occurrence rates of local reaction and systemic reaction were 1.0%(2/200)and 5.5%(10/200)respectively.For the younger group and older group,the adverse reaction rates were 8.0%and 4.0%respectively.Conclusion This vaccineis safe in children aged 6 months to 11 years old.
