Diphtheria-tetanus-acellular pertussis and inactivated poliovirus vaccines given separately or combined for booster dosing at 4-6 years of age.
BACKGROUND
In the United States, diphtheria-tetanus-acellular pertussis (DTaP) and inactivated poliovirus (IPV) booster vaccinations are recommended for children 4-6 years of age. A combined DTaP-IPV vaccine is being developed, which would reduce by one the number of injections in this age group.


METHODS
Children 4-6 years of age were randomized (1:1:1:1) to receive booster vaccination with 1 of 3 combined DTaP-IPV lots plus the measles, mumps, and rubella vaccine (N = 3156 for pooled lots) or separate doses of DTaP + IPV + measles, mumps, and rubella vaccine (N = 1053). Immunogenicity was assessed in a subset of children (N = 1331). Safety (solicited and unsolicited symptoms) including detailed assessment of local swelling reactions, was assessed in all children.


RESULTS
Increases in antibody geometric mean concentrations/titers 1 month after vaccination were observed for the diphtheria, tetanus, acellular pertussis, and polio antigens. At least 92.2% of combined DTaP-IPV subjects and 92.6% of separate DTaP + IPV subjects had a postvaccination booster response for one or more DTaP antigens. Booster responses to one or more poliovirus antigens were observed in at least 96.6% of combined DTaP-IPV subjects and 92.8% of separate DTaP + IPV subjects. The combined DTaP-IPV vaccine was noninferior to separately administered DTaP and IPV vaccines with respect to DTaP antigen booster response rates and poliovirus antibody geometric mean titers ratios. Reporting of solicited local and systemic events was comparable between both groups.


CONCLUSIONS
The combination DTaP-IPV vaccine provided immunogenicity and reactogenicity that is comparable to separately administered DTaP and IPV vaccines, with the advantage of requiring one less injection.
Black
Steven
S
Stanford University, Palo Alto, CA, USA.
Friedland
Leonard R
LR
Ensor
Kathleen
K
Weston
Wayde M
WM
Howe
Barbara
B
Klein
Nicola P
NP
D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D002675:Child, Preschool; D004165:Diphtheria / Q000517:prevention & control; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D008458:Measles Vaccine / Q000008:administration & dosage; D009108:Mumps Vaccine / Q000008:administration & dosage; D011051:Poliomyelitis / Q000517:prevention & control; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D012411:Rubella Vaccine / Q000008:administration & dosage; D013742:Tetanus / Q000517:prevention & control; D014481:United States; D014917:Whooping Cough / Q000517:prevention & control
D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D008458:Measles Vaccine; D009108:Mumps Vaccine; D011054:Poliovirus Vaccine, Inactivated; D012411:Rubella Vaccine