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.
BACKGROUND
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.


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.


CONCLUSIONS
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.
Phua
Kong Boo
KB
Department of Paediatrics, KK Women's and Children's Hospital, National University Hospital, Singapore. phua.kong.boo@kkh.com.sg
Quak
Seng Hock
SH
Lim
Fong Seng
FS
Goh
Paul
P
Teoh
Yee Leong
YL
Datta
Sanjoy Kumar
SK
Han
Htay Htay
HH
Bock
Hans Ludwig
HL
D002648:Child; D002669:Child Welfare; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control*; D019741:Haemophilus influenzae type b / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D010349:Patient Compliance; D011051:Poliomyelitis / Q000517:prevention & control*; D022243:Rotavirus Vaccines; D012846:Singapore; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate / Q000009:adverse effects* / Q000276:immunology*
D022243:Rotavirus Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate