title: 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.
abstract: 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.
authors.affiliation: Department of Paediatrics, KK Women's and Children's Hospital, National University Hospital, Singapore. phua.kong.boo@kkh.com.sg
authors.forename: Kong Boo
authors.initials: KB
authors.lastname: Phua
authors.forename: Seng Hock
authors.initials: SH
authors.lastname: Quak
authors.forename: Fong Seng
authors.initials: FS
authors.lastname: Lim
authors.forename: Paul
authors.initials: P
authors.lastname: Goh
authors.forename: Yee Leong
authors.initials: YL
authors.lastname: Teoh
authors.forename: Sanjoy Kumar
authors.initials: SK
authors.lastname: Datta
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
authors.forename: Hans Ludwig
authors.initials: HL
authors.lastname: Bock
mesh_terms: 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*
chemical_list: D022243:Rotavirus Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate