A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw-HBV-Hib, a liquid pentavalent vaccine in Indian infants

被引：16
|
作者：
Sharma, Hitt [1 ]
Yadav, Sangita [2 ,3 ]
Lalwani, Sanjay [4 ]
Gupta, Vijay [5 ]
Kapre, Subhash [1 ]
Jadhav, Suresh [1 ]
Chakravarty, Anita [6 ]
Parekh, Sameer [1 ]
Palkar, Sonali [4 ]
机构：
[1] Serum Inst India Ltd, Pune 411028, Maharashtra, India
[2] Maulana Azad Med Coll, Dept Pediat, New Delhi, India
[3] Associated LNJP Hosp, New Delhi, India
[4] Bharati Vidyapeeth Univ, Dept Pediat, Med Coll & Hosp, Pune, Maharashtra, India
[5] Dr Ram Manohar Lohia Hosp, Dept Pediat & Neonatol, New Delhi, India
[6] Maulana Azad Med Coll, Dept Microbiol, New Delhi, India
来源：
VACCINE | 2011年 / 29卷 / 13期
关键词：
Liquid pentavalent vaccine; Combination vaccine; Immunogenicity; Safety; India; EVENT FOLLOWING IMMUNIZATION; CASE-DEFINITION; DATA-COLLECTION; INJECTION SITE; GUIDELINES; SAFETY; POLYSACCHARIDE; BURDEN;
D O I：
10.1016/j.vaccine.2011.01.054
中图分类号：
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号：
100102 ;
摘要：
Immunogenicity and tolerability of two liquid pentavalent vaccines, Pentavac (R) (new vaccine), and Easyfive (R) (available in the market) was assessed in a multicentre study in India. In all, 484 infants aged 6-8 weeks were enrolled, and their blood samples were assessed prior to the first dose and one month after the third dose. A 100% seroprotection rate was achieved with both vaccines' antigens, except pertussis for which the response was 95% and 96%, respectively, for the two vaccines. A diary-based recording of adverse events showed that the two most common events were pain at the injection site and restricted limb movements and were less frequent (p < 0.001) among the recipients of the new vaccine. The new vaccine meets all criteria of childhood vaccination. Its low reactogenicity and low cost are valid reasons to recommend this vaccine for general use. (C) 2011 Elsevier Ltd. All rights reserved.
引用
收藏
页码：2359 / 2364
页数：6
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