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Clinical evaluation of a DTaP-HepB-IPV combined vaccine.

OBJECTIVE
To provide an overview of prelicensure clinical data for a new pediatric vaccine that combines diphtheria, tetanus, acellular pertussis, hepatitis B, and inactivated poliovirus vaccines into a single injection (DTaP-HepB-IPV combined vaccine; Pediarix, GlaxoSmithKline Biologicals, Rixensart, Belgium).


METHODS
The safety and immunogenicity of DTaP-HepB-IPV combined vaccine have been evaluated extensively in clinical trials in infants. To date, DTaP-HepB-IPV combined vaccine has been administered to more than 7,000 infants as a 3-dose primary series during the first year of life.


RESULTS
Studies show that DTaP-HepB-IPV combined vaccine is generally safe, well tolerated, and has not caused any significant serious adverse events. The rates of solicited and unsolicited reports of adverse reactions following vaccination were similar between groups receiving DTaP-HepB-IPV combined vaccine and comparator groups receiving the vaccine components separately. DTaP-HepB-IPV combined vaccine induces immunogenicity (as measured by seroprotection or vaccine response rates to each of the vaccine components [diphtheria, tetanus, 3 pertussis antigens, hepatitis B, and poliovirus types 1, 2, and 31) similar to licensed vaccine components administered separately.


CONCLUSION
In prelicensure clinical studies, DTaP-HepB-IPV combined vaccine was safe and immunogenic when given to infants as a primary 3-dose series. As a single injection of multiple vaccine components, DTaP-HepB-IPV combined vaccine may provide a safe and effective alternative to the current multiple-injection immunization regimen.