Safety, reactogenicity and immunogenicity of a combined hexavalent tetanus, diphtheria, acellular pertussis, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b conjugate vaccine, for primary immunization of infants.
Safety, reactogenicity and immunogenicity of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix)hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age (N = 2163), compared to the separate administration of DTPa-IPV/Hib and HBV vaccines (N = 720). A similar safety and reactogenicity profile was demonstrated for both vaccine regimens, as well as a good immune response for all antigen components. By offering protection against six diseases in a series of single injections, the hexavalent DTPa-HBV-IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines.
Zepp
F
F
Children's Hospital, Johannes-Gutenberg-University, Langenbeckstrasse 1, 55101 Mainz, Germany. zepp@kinder.klinik.uni-mainz.de
Knuf
M
M
Heininger
U
U
Jahn
K
K
Collard
A
A
Habermehl
P
P
Schuerman
L
L
Sänger
R
R
D016667:Bacterial Capsules; D004165:Diphtheria / Q000517:prevention & control; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006509:Hepatitis B / Q000517:prevention & control; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D010567:Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011051:Poliomyelitis / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D011135:Polysaccharides, Bacterial / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D013742:Tetanus / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014917:Whooping Cough / Q000517:prevention & control
C051021:DTPP vaccine; D004168:Diphtheria Toxoid; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D017325:Hepatitis B Vaccines; C426944:Hexavac; D010567:Pertussis Vaccine; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D013745:Tetanus Toxoid; D017778:Vaccines, Combined