A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac®) in India

被引：24

作者：

Kulkarni, Prasad S. ^{[1
]}

Raut, Sidram K. ^{[2
]}

Dhere, Rajeev M. ^{[1
]}

机构：

[1] Serum Inst India Ltd, Pune, Maharashtra, India

[2] Nobel Hosp, Pune, Maharashtra, India

来源：

HUMAN VACCINES & IMMUNOTHERAPEUTICS | 2013年 / 9卷 / 01期

关键词：

live attenuated; pandemic H1N1 vaccine; post-marketing surveillance;

D O I：

10.4161/hv.22317

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (>= 3 y) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 d. Among 7,565 individuals (3-85 y), a total of 81 solicited adverse reactions (1%) were reported in 49 subjects (0.65%). The reactions included mild to moderate respiratory symptoms. No H1N1 case was encountered during one year post vaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.

引用

页码：122 / 124

页数：3

共 9 条

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