Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants / 소아감염
Korean Journal of Pediatric Infectious Diseases
;
: 156-168, 2010.
Artigo
em Inglês
| WPRIM
| ID: wpr-219041
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Agendamento de Consultas
/
Vacinas
/
Coqueluche
/
Incidência
/
Imunização
/
Vacinação
/
Poliovirus
/
Ácido Pentético
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo de incidência
/
Estudo prognóstico
Limite:
Idoso
/
Humanos
/
Lactente
Idioma:
Inglês
Revista:
Korean Journal of Pediatric Infectious Diseases
Ano de publicação:
2010
Tipo de documento:
Artigo
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