Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants

被引：60

作者：

Narang, Anil ^{[2
]}

Bose, Anuradha ^{[3
]}

Pandit, Anand Nilkanth ^{[4
]}

Dutta, Phalguni ^{[5
]}

Kang, Gagandeep ^{[3
]}

Bhattacharya, Sujit Kumar ^{[5
]}

Datta, Sanjoy Kumar ^{[1
]}

Suryakiran, P. V. ^{[1
]}

Delem, Andree ^{[1
]}

Han, Htay Htay ^{[1
]}

Bock, Hans Ludwig ^{[1
]}

机构：

[1] GlaxoSmithKline Biol, B-1330 Rixensart, Belgium

[2] Postgrad Inst Med Educ & Res, Chandigarh 160012, India

[3] Christian Med Coll & Hosp, Vellore, Tamil Nadu, India

[4] King Edward Mem Hosp Women, Pune, Maharashtra, India

[5] Natl Inst Cholera & Enter Dis, Kolkata, India

来源：

HUMAN VACCINES | 2009年 / 5卷 / 06期

关键词：

rotavirus; gastrointestinal disease; vaccine; immunogenicity; reactogenicity; safety; 1ST; 2; YEARS; DOUBLE-BLIND; EFFICACY; GASTROENTERITIS; PROTECTION; DISEASE; DEATHS; LIFE;

D O I：

10.4161/hv.5.6.8176

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：

Aim: This study was undertaken to assess the immunogenicity, reactogenicity and safety of two doses of an oral live-attenuated human rotavirus vaccine, strain RIX4414 (Rotarix(TM)) in an Indian setting. Results: The seroconversion rate observed one month post-dose 2 in the RIX4414 group 58.3% [95% CI: 48.7; 67.4] was significantly higher when compared to the placebo group 6.3%; [95% CI: 2.5; 12.5]. The reactogenicity and safety profile was similar for both groups. Patients and methods: Healthy infants (N = 363), approximately eight weeks of age were enrolled to receive two doses of RIX4414 vaccine (n = 182) or placebo (n = 181) separated by one month. To assess the immune response, blood samples were taken before vaccination and one month post-dose 2 of RIX4414/placebo. Solicited symptoms were collected for eight-days post each dose and safety data was collected throughout the study. Conclusions: Two doses of RIX4414 (Rotarix(TM)) were immunogenic, had a good safety profile and were well-tolerated when administered to healthy Indian infants.

引用

页码：414 / 419

页数：6

共 24 条

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