Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants.
- Author:
Chang Hwi KIM
1
;
Sung Ho CHA
;
Son Moon SHIN
;
Chun Soo KIM
;
Young Youn CHOI
;
Young Jin HONG
;
Myoung Jae CHEY
;
Kwang Nam KIM
;
Jae Kyun HUR
;
Dae Sun JO
;
Sung Shin KIM
;
Sang Lak LEE
;
Eun Song SONG
;
Gunasekaran RAMAKRISHNAN
;
Jin Ju OK
;
Olivier VAN DER MEEREN
;
Hans L BOCK
;
Jung Soo KIM
Author Information
1. Department of Pediatrics, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
- Publication Type:Original Article ; Randomized Controlled Trial
- Keywords:
Acellular pertussis;
DTPa-IPV;
DTPa;
IPV;
Primary vaccination
- MeSH:
Aged;
Appointments and Schedules;
Humans;
Immunization;
Incidence;
Infant;
Pentetic Acid;
Poliovirus;
Vaccination;
Vaccines;
Whooping Cough
- From:Korean Journal of Pediatric Infectious Diseases
2010;17(2):156-168
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, Infanrix(TM) IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). METHODS: A total of 458 infants aged 8-12 weeks were randomized to receive three-dose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. RESULTS: One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were > or =99.5% and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. CONCLUSION: Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.
