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Rong Cheng Li,
Feng Xiang Li,
Yan Ping Li,
Qi Ming Hou,
Chang Gui Li,
Ya Nan Li,
Fu Sheng Chen,
Xue Zhong Hu,
Wen Bin Su,
Shu Min Zhang,
Han Hua Fang,
Qiang Ye, Tian De Zeng,
Tao Xuan Liu,
Xiu Bi Li,
Yun Neng Huang,
Man Ling Deng,
Yan Ping Zhang,
Esteban Ortiz
[show abstract]
[hide abstract]
ABSTRACT: This study assessed the antibody persistence, and the immunogenicity and safety of a booster dose of a DTaP-IPV//PRP∼T (Pentaxim®, Sanofi Pasteur's AcXim family) combined vaccine and of standalone vaccines one year after primary vaccination in the People's Republic of China. Participants (N=719) previously primed with DTaP-IPV//PRP∼T at 2, 3, 4 months (Group A, N=255), 3, 4, 5 months (Group B, N=233), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib®) and IPV (Imovax® Polio) at 3, 4, 5 months (Group C, N=231) received boosters of the same vaccines at 18-20 months of age. Seroprotection (SP) and seroconversion (SC) were determined before and 1 month after the booster. Safety was monitored from parental reports. In all groups 87.6-100% of participants had pre-booster protective anti-PRP, -diphtheria, -tetanus and -poliovirus antibody titers; post-booster, all SP rates were 100% and SC was ≥ 80.4% for anti-pertussis titers ≥ 4-fold increase. Reactogenicity was low for each group. These data support the use of the DTaP-IPV//PRP∼T vaccine in the People's Republic of China compared to separate DTaP, IPV, and PRP∼T administration in terms of both safety and immunogenicity.
Vaccine 11/2011; 29(50):9337-44. · 3.77 Impact Factor
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Yan-ping Li,
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 Fang,
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
[show abstract]
[hide abstract]
ABSTRACT: 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.
Subjects were randomly divided into three groups, Group A and Group B were DTaP-IPV//PRP-T combined vaccine (PENTAXIM(TM)) 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-HIB(TM)) and IPV (IMOVAX PolioTM(TM)) 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.
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.
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.
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 08/2011; 32(8):808-15.
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Rong Cheng Li,
Feng Xiang Li,
Yan Ping Li,
Qi Ming Hou,
Chang Gui Li,
Ya Nan Li,
Fu Sheng Chen,
Xue Zhong Hu,
Wen Bin Su,
Shu Min Zhang,
Han Hua Fang,
Qiang Ye, Tian De Zeng,
Tao Xuan Liu,
Xiu Bi Li,
Yun Neng Huang,
Man Ling Deng,
Yan Ping Zhang,
Esteban Ortiz
[show abstract]
[hide abstract]
ABSTRACT: The aim was to demonstrate the immunogenicity and safety of a DTaP-IPV//PRP-T combined vaccine (Pentaxim(®)) compared to individual vaccines in infants in the People's Republic of China. Infants (N=792) were randomly assigned to receive DTaP-IPV//PRP-T at 2, 3 and 4 months of age (Group A) or 3, 4 and 5 months of age (Group B), or DTaP (Wuhan Institute of Biological Products), PRP-T (Act-Hib(®)) and IPV (Imovax(®) Polio) at 3, 4 and 5 months of age (Group C). Antibody titers were measured pre- and 1 month after the third vaccination; non-inferiority analyses were performed for seroprotection/seroconversion (SP/SC) rates. Safety was assessed 1 month after the primary series. SP/SC rates for the DTaP-IPV//PRP-T vaccine were high and non-inferior to the controls. Reactogenicity was low for each group and no hypotonic hyporesponsive episode or seizure was reported. In conclusion, the DTaP-IPV//PRP-T vaccine was highly immunogenic, non-inferior to the commercially available control vaccines and had a good safety profile for both primary administration schedules.
Vaccine 02/2011; 29(10):1913-20. · 3.77 Impact Factor