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Combination Vaccine for Children
In December 2002 the FDA announced approval of Pediarix,
a combination vaccine that protects infants against diphtheria,
tetanus, whooping cough (pertussis), polio, and disease
due to the hepatitis B virus. Pediarix is the only vaccine
marketed in the United States that contains DTaP (diphtheria
and tetanus toxoids and acellular pertussis), hepatitis
B vaccine (recombinant), and inactivated poliovirus vaccine
(IPV) for administration as one injection.
Pediarix is recommended for administration as a 3-dose
primary series to infants at approximately 2, 4, and 6 months
of age. Pediarix should not be given to infants before the
age of 6 weeks, and is not indicated for infants born to
mothers who are infected with hepatitis B or whose hepatitis
B status is not known. Such infants should receive hepatitis
B vaccine shortly after birth and complete their immunizations
according to a recommended schedule. The Childhood
Immunization Schedule is available from the Centers
for Disease Control and Prevention.
In a trial with the administration of the vaccine at 2,
4, and 6 months of age, immune responses induced by Pediarix
were generally similar to those induced by vaccines administered
separately. The most frequently reported adverse reactions
to Pediarix were pain, swelling, and redness at the site
of the injection, fever, and fussiness. In clinical studies,
fever occurred more frequently after administration of Pediarix
than when the vaccines were administered separately.
DTaP vaccine, hepatitis B vaccine and IPV are all currently
available in the United States as separate vaccines.
Pediarix is marketed by SmithKline Beecham Pharmaceuticals
of Philadelphia.
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