title: Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization.
abstract: To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage I, 480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3, 4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1, 4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (> or = 0.1IU/ml), anti-TT (> or = 0.1IU/ml) and anti-PRP (> or = 0.15 microg/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children.
authors.affiliation: Beijing Minhai Biotechnology Co. Ltd., Beijing, China.
authors.forename: Guifan
authors.initials: G
authors.lastname: Li
authors.forename: Huajie
authors.initials: H
authors.lastname: Zhang
authors.forename: Weizhong
authors.initials: W
authors.lastname: Zhou
authors.forename: Qiang
authors.initials: Q
authors.lastname: Ye
authors.forename: Fengxiang
authors.initials: F
authors.lastname: Li
authors.forename: Hua
authors.initials: H
authors.lastname: Wang
authors.forename: Qiming
authors.initials: Q
authors.lastname: Hou
authors.forename: Yinghua
authors.initials: Y
authors.lastname: Xu
authors.forename: Xiao
authors.initials: X
authors.lastname: Ma
authors.forename: Yajun
authors.initials: Y
authors.lastname: Tan
authors.forename: Lichan
authors.initials: L
authors.lastname: Wang
authors.forename: Yanan
authors.initials: Y
authors.lastname: Li
authors.forename: Hong
authors.initials: H
authors.lastname: Li
authors.forename: Fanyue
authors.initials: F
authors.lastname: Meng
authors.forename: Qi
authors.initials: Q
authors.lastname: Liang
authors.forename: Aimin
authors.initials: A
authors.lastname: Liu
authors.forename: Chengkui
authors.initials: C
authors.lastname: Qin
authors.forename: Wenjin
authors.initials: W
authors.lastname: Wei
authors.forename: Jiankai
authors.initials: J
authors.lastname: Liu
authors.forename: Chengmai
authors.initials: C
authors.lastname: Ruan
authors.forename: Wenjian
authors.initials: W
authors.lastname: Tao
authors.forename: Shumin
authors.initials: S
authors.lastname: Zhang
authors.forename: Haifa
authors.initials: H
authors.lastname: Zheng
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D002681:China / Q000453:epidemiology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D006192:Haemophilus Infections / Q000453:epidemiology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D018074:Vaccines, Conjugate / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D018074:Vaccines, Conjugate; C080881:diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine