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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>
Assuntos
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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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