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.
Ann Acad Med Singap
; 37(7): 546-53, 2008 Jul.
Article
em En
| MEDLINE
| ID: mdl-18695765
ABSTRACT
INTRODUCTION:
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. MATERIALS ANDMETHODS:
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.RESULTS:
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.CONCLUSION:
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Poliomielite
/
Vacinas Conjugadas
/
Haemophilus influenzae tipo b
/
Vacinas contra Rotavirus
/
Infecções por Haemophilus
Tipo de estudo:
Clinical_trials
Limite:
Child
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
/
Newborn
País/Região como assunto:
Asia
Idioma:
En
Ano de publicação:
2008
Tipo de documento:
Article