PMID- 19124057
OWN - NLM
STAT- MEDLINE
DCOM- 20090615
LR  - 20090408
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 27
IP  - 19
DP  - 2009 Apr 28
TI  - Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular 
      pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B 
      vaccine at 2, 3, 4, and 12-14 months of age.
PG  - 2540-7
LID - 10.1016/j.vaccine.2008.11.115 [doi]
AB  - Combination vaccines improve parental and provider satisfaction and schedule 
      compliance by decreasing the number of injections. In a Phase 2, randomized, 
      double-blind, multicenter study, we compared four formulations of a liquid, 
      hexavalent diphtheria-tetanus-acellular pertussis-inactivated 
      poliovirus-Haemophilus influenzae b conjugate-hepatitis B virus 
      (DTaP-IPV-Hib-HBV) vaccine in 708 infants immunized at 2, 3, 4, and 12-14 months 
      of age. The formulations contained identical DTaP and IPV components, differing 
      in the contents of Hib polyribosylribitol phosphate (PRP) conjugate component 
      (tetanus-toxoid [PRP-T, 12microg] or Neisseria meningitidis 
      outer-membrane-protein-complex [PRP-OMPC, 3microg or 6microg]), and in hepatitis 
      B surface antigen (HBsAg, 10microg or 15microg). A minimum acceptable postdose 3 
      antibody response rate was defined by the lower limit of the 95% confidence 
      interval exceeding a prespecified target. Rates of adverse events (AEs) were 
      similar among groups, with a trend for increased solicited injection-site 
      reactions (pain, redness, swelling) with increasing PRP-OMPC and HBsAg 
      concentration. Serious AEs reported by eight subjects were not considered to be 
      vaccine related. All PRP-OMPC formulations met prespecified acceptability 
      criteria for postdose 3 immunogenicity for all antigens: PRP, HBsAg, pertussis, 
      diphtheria, tetanus and polio. Apart from the Hib response, the postdose 3 
      responses obtained with the PRP-T formulation met the acceptability criterion for 
      each antigen. Postdose 4 responses were acceptable for all antigens in all 
      formulations. All vaccine formulations were well tolerated. The three PRP-OMPC 
      formulations met prespecified immunogenicity criteria, and the one with the 
      lowest PRP-OMPC concentration was selected for further optimization of 
      immunogenicity.
FAU - Halperin, Scott A
AU  - Halperin SA
AD  - Clinical Trials Research Center, Canadian Center for Vaccinology, Dalhousie 
      University and the IWK Health Centre, Halifax, Nova Scotia, Canada. 
      scott.halperin@dal.ca
FAU - Tapiero, Bruce
AU  - Tapiero B
FAU - Diaz-Mitoma, Francisco
AU  - Diaz-Mitoma F
FAU - Law, Barbara J
AU  - Law BJ
FAU - Hoffenbach, Agnes
AU  - Hoffenbach A
FAU - Zappacosta, Pamela S
AU  - Zappacosta PS
FAU - Radley, David
AU  - Radley D
FAU - McCarson, Barbara J
AU  - McCarson BJ
FAU - Martin, Jason C
AU  - Martin JC
FAU - Brackett, Laura E
AU  - Brackett LE
FAU - Boslego, John W
AU  - Boslego JW
FAU - Hesley, Teresa M
AU  - Hesley TM
FAU - Bhuyan, Prakash K
AU  - Bhuyan PK
FAU - Silber, Jeffrey L
AU  - Silber JL
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090103
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Bacterial)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Conjugate)
RN  - 0 (diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus 
      influenzae b conjugate-hepatitis B vaccine)
SB  - IM
MH  - Antibodies, Bacterial/blood
MH  - Antibodies, Viral/blood
MH  - Chemistry, Pharmaceutical
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/*adverse 
      effects/*immunology
MH  - Female
MH  - Haemophilus Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Hepatitis B Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Humans
MH  - Immunization, Secondary
MH  - Infant
MH  - Male
MH  - Poliovirus Vaccine, Inactivated/administration & dosage/*adverse 
      effects/*immunology
MH  - Vaccines, Combined/administration & dosage/adverse effects/immunology
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
EDAT- 2009/01/07 09:00
MHDA- 2009/06/16 09:00
CRDT- 2009/01/07 09:00
PHST- 2008/09/11 00:00 [received]
PHST- 2008/11/10 00:00 [revised]
PHST- 2008/11/12 00:00 [accepted]
PHST- 2009/01/07 09:00 [entrez]
PHST- 2009/01/07 09:00 [pubmed]
PHST- 2009/06/16 09:00 [medline]
AID - S0264-410X(08)01575-2 [pii]
AID - 10.1016/j.vaccine.2008.11.115 [doi]
PST - ppublish
SO  - Vaccine. 2009 Apr 28;27(19):2540-7. doi: 10.1016/j.vaccine.2008.11.115. Epub 2009 
      Jan 3.