Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China

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

doi:10.1016/j.vaccine.2010.12.103

Immunogenicity and safety of a pentavalent acellular pertussis combined vaccine including diphtheria, tetanus, inactivated poliovirus and conjugated Haemophilus Influenzae type b polysaccharide for primary vaccination at 2, 3, 4 or 3, 4, 5 months of age in infants in China

Vaccine. 2011 Feb 24;29(10):1913-20. doi: 10.1016/j.vaccine.2010.12.103. Epub 2011 Jan 8.

Affiliation

¹ Guanxi Autonomous Region Center for Disease Prevention and Control, China.

PMID: 21219984
DOI: 10.1016/j.vaccine.2010.12.103

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.

Trial registration: ClinicalTrials.gov NCT00453570.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Age Factors
Antibodies, Bacterial / blood
Antibodies, Viral / blood
China
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Female
Haemophilus Vaccines / administration & dosage
Haemophilus Vaccines / adverse effects*
Haemophilus Vaccines / immunology*
Hepatitis B Vaccines / administration & dosage
Hepatitis B Vaccines / adverse effects*
Hepatitis B Vaccines / immunology*
Humans
Immunization, Secondary / methods*
Infant
Male
Poliovirus Vaccine, Inactivated / administration & dosage
Poliovirus Vaccine, Inactivated / adverse effects*
Poliovirus Vaccine, Inactivated / immunology*
Vaccination / methods*
Vaccines, Combined
Vaccines, Conjugate / administration & dosage
Vaccines, Conjugate / adverse effects
Vaccines, Conjugate / immunology

Substances

Antibodies, Bacterial
Antibodies, Viral
Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Hepatitis B Vaccines
Poliovirus Vaccine, Inactivated
Vaccines, Combined
Vaccines, Conjugate
diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Associated data

ClinicalTrials.gov/NCT00453570