Immunogenicity and safety of DTaP-IPV//PRP-T combined vaccine in infants in China
10.3760/cma.j.issn.0254-6450.2011.08.017
- VernacularTitle:中国婴幼儿接种吸附无细胞百白破灭活脊髓灰质炎和b型流感嗜血杆菌(结合)联合疫苗的安全性和免疫原性研究
- Author:
Yan-Ping LI
1
;
Feng-Xiang LI
;
Qi-Ming HOU
;
Chang-Gui LI
;
Ya-Nan LI
;
Fu-Sheng CHEN
;
Xue-Zhong HU
;
Wen-Bin SU
;
Shu-Min ZHANG
;
Han-hua NG FA
;
Qiang YE
;
Tian-De ZENG
;
Tao-Xuan LIU
;
Xiu-Bi LI
;
Yun-Neng HUANG
;
Man-Ling DENG
;
Rong-Cheng LI
;
Yan-Ping ZHANG
;
Ortiz ESTEBAN
Author Information
1. 广西壮族自治区疾病预防控制中心
- Keywords:
Combined vaccine;
Immunogenicity;
Safety;
Primary;
Booster
- From:Chinese Journal of Epidemiology
2011;32(8):808-815
- CountryChina
- Language:Chinese
-
Abstract:
Objective The aim of this study was to demonstrate the immunogenicity and safety of diphtheria, tetanus, pertussis (acellular, component) , poliomyelitis (inactivated) vaccine (adsorbed) and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV//PRP-T) combined vaccine compared with commercially available DTaP (diphtheria, tetanus and pertussis), Haemophilus influenzae type b (Hib), tetanus conjugate and IPV monovalent vaccine. Methods Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIMTM) vaccinated at 2,3,4 months of age or 3,4, 5 months of age respectively; Group C was commercially available DTaP. Hib tetanus conjugate (Act-HIBTM) and IPV (IMOVAX PolioTM) vaccines vaccinated at 3,4, 5 months of age. All groups received booster dose at 18 to 20 months of age, with antibody titers tested. Non-inferiority analysis was demonstrated in terms of seroprotection / seroconversion rates between Group A, Group B respectively and Group C. Safety information was collected after each vaccination to assess the safety of investigational vaccines. Results The non-inferiority of DTaP-IPV//PRP-T combined vaccine vaccinated at 2,3,4 or 3,4, 5 months of age versus DTaP, Hib tetanus conjugate and IPV vaccine was demonstrated for all vaccine antigens in both primary and booster phases in terms of seroprotection/seroconversion rates. DTaP-IPV//PRP-T combined vaccine was well tolerated. The rate of solicited/unsoliciated severe adverse reactions was very low and similar to the control vaccines. Conclusion DTaP-IPV//PRP-T combined vaccine was highly immunogenic with good safety profile in Chinese infants, which was comparable to the commercially available control vaccines.
