Immunogenicity, reactogenicity and safety of a diphtheria-tetanus-acellular pertussis-inactivated polio and Haemophilus influenzae type b vaccine in a placebo-controlled rotavirus vaccine study
Annals of the Academy of Medicine, Singapore
;
: 546-553, 2008.
Artigo
em Inglês
| WPRIM
| ID: wpr-358778
ABSTRACT
<p><b>INTRODUCTION</b>In recent years, acellular pertussis combination vaccines have facilitated compliance with and coverage of the national immunisation programme in Singapore. This phase-II study (Rota-007) evaluated the immunogenicity, reactogenicity and safety of a DTPa-IPV/Hib combined vaccine when co-administered with a rotavirus vaccine.</p><p><b>MATERIALS AND METHODS</b>A total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 13 ratio of either placebo (n=653) or 1 of 3 different formulations of a rotavirus vaccine. Blood samples were collected for immunogenicity analysis 1 month after the third DTPa-IPV/Hib vaccine dose in a subset of subjects (n = 640). Local and general reactogenicity and unsolicited adverse events were recorded during the follow-up after each vaccination.</p><p><b>RESULTS</b>Serological analysis showed >95% response for all antigens in the co-administered DTPa-IPV/Hib vaccine, with no difference between the rotavirus vaccine and placebo groups. No differences in adverse events and reactogenicity were reported in the rotavirus vaccine and placebo groups. Only 0.2% of the subjects reported Grade 3 adverse events. Three subjects (from the vaccine groups) died during the study, which were assessed by the investigators as unrelated to vaccination. No deaths were reported in the placebo group.</p><p><b>CONCLUSION</b>The combined DTPa- IPV/Hib vaccine is safe, well tolerated and highly immunogenic when given alone or coadministered with the rotavirus vaccine for infants in Singapore.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Poliomielite
/
Singapura
/
Proteção da Criança
/
Método Duplo-Cego
/
Cooperação do Paciente
/
Vacinas Conjugadas
/
Vacinas Combinadas
/
Haemophilus influenzae tipo b
/
Vacinas contra Rotavirus
/
Alergia e Imunologia
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Criança
/
Criança, pré-escolar
/
Feminino
/
Humanos
/
Lactente
/
Masculino
/
Recém-Nascido
País/Região como assunto:
Ásia
Idioma:
Inglês
Revista:
Annals of the Academy of Medicine, Singapore
Ano de publicação:
2008
Tipo de documento:
Artigo
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