• Vol. 37 No. 7, 546–553
  • 15 July 2008

Immunogenicity, Reactogenicity and Safety of a Diphtheria-Tetanus-Acellular Pertussis-Inactivated Polio and Haemophilus Influenzae Type b Combination Vaccine in a Placebo-controlled Rotavirus Vaccine Study

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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 and Methods: A total of 2464 children aged 3 months were vaccinated with DTPa-IPV/Hib together with a randomised 1:3 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 co administered with the rotavirus vaccine for infants in Singapore.


Singapore’s national immunisation programme for the 6 traditional Expanded Programme on Immunisation (EPI) vaccines (i.e. BCG, diphtheria, tetanus, pertussis, polio and measles) and hepatitis B has been in place for many years and its success has been dramatic. Despite being previously endemic to Singapore in the 1950s, diphtheria has not been reported for several years.

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