title: Safety, immunogenicity and persistence of immune response to the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-IPV/Hib) administered in Chinese infants.
abstract: We conducted 3 phase III, randomized, open-label, clinical trials assessing the safety, reactogenicity (all studies), immunogenicity (Primary vaccination study) and persistence of immune responses (Booster study) to the combined diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Chinese infants and toddlers. In the Pilot study (NCT00964028), 50 infants (randomized 1:1) received 3 doses of DTPa-IPV/Hib at 2-3-4 (Group A) or 3-4-5 months of age (Group B). In the Primary study (NCT01086423), 984 healthy infants (randomized 1:1:1) received 3 doses of DTPa-IPV/Hib at 2-3-4 (Group A) or 3-4-5 (Group B) months of age, or concomitant DTPa/Hib and poliomyelitis (IPV) vaccination at 2-3-4 months of age (Control group); 825 infants received a booster dose of DTPa/Hib and IPV at 18-24 months of age (Booster study; NCT01449812). In the Pilot study, unsolicited symptoms were more frequent in Group A (16 versus 1 infant; mostly upper respiratory tract infection and pyrexia); this observation was attributed to an epidemic outbreak of viral infections. Non-inferiority of 3-dose primary vaccination with DTPa-IPV/Hib over separately administered DTPa/Hib and IPV was demonstrated for Group A (primary objective). Similar antibody concentrations were observed in all groups, except for anti-polyribosyl-ribitol phosphate and anti-poliovirus types 1-3 which were higher in DTPa-IPV/Hib recipients. Protective antibody levels against all vaccine antigens remained high until booster vaccination. Three-dose vaccination with DTPa-IPV/Hib had a clinically acceptable safety profile.
authors: a Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention , Nanning City , Guangxi , China.
authors: Yanping
authors: Y
authors: Li
authors: a Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention , Nanning City , Guangxi , China.
authors: Rong Cheng
authors: RC
authors: Li
authors: b National Institutes for Food and Drug Control , Beijing , China.
authors: Qiang
authors: Q
authors: Ye
authors: b National Institutes for Food and Drug Control , Beijing , China.
authors: Changgui
authors: C
authors: Li
authors: c Wuzhou Center for Disease Control and Prevention , Wuzhou City , Guangxi , China.
authors: You Ping
authors: YP
authors: Liu
authors: b National Institutes for Food and Drug Control , Beijing , China.
authors: Xiao
authors: X
authors: Ma
authors: b National Institutes for Food and Drug Control , Beijing , China.
authors: Yanan
authors: Y
authors: Li
authors: c Wuzhou Center for Disease Control and Prevention , Wuzhou City , Guangxi , China.
authors: Hong
authors: H
authors: Zhao
authors: d Mengshan Center for Disease Control and Prevention , Disease Prevention, Development District , Wuzhou City , Guangxi , China.
authors: Xiaoling
authors: X
authors: Chen
authors: e GSK , Bangalore , India.
authors: Deepak
authors: D
authors: Assudani
authors: e GSK , Bangalore , India.
authors: Naveen
authors: N
authors: Karkada
authors: f GSK , King of Prussia , PA , USA.
authors: Htay Htay
authors: HH
authors: Han
authors: g GSK , Wavre , Belgium.
authors: Olivier
authors: O
authors: Van Der Meeren
authors: g GSK , Wavre , Belgium.
authors: Narcisa
authors: N
authors: Mesaros
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D000914:Antibodies, Viral / Q000097:blood*; D002681:China; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013997:Time Factors; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D018074:Vaccines, Conjugate; C541234:diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine
keywords: DTPa-IPV/Hib; Haemophilus influenzae type b; acellular pertussis; conjugate vaccine; diphtheria; immunogenicity; infants; poliovirus; safety; tetanus