A new combination vaccine may reduce the number of injections required to keep infants and toddlers up to date with the United States infant immunization schedule recommended by the Centers for Disease Control and Prevention. In a phase III trial reported in the August 2015 issue of Pediatrics, the vaccine was determined to be effective, safe and well-tolerated. Gary S. Marshall, M.D., professor of pediatrics at the University of Louisville, was the principal investigator of the multi-center trial and first author of the report.
The hexavalent vaccine combination, known as DTaP5-IPV-Hib-HepB, is aligned with the recommended immunization schedule and is expected to protect children against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b (Hib) and hepatitis B. The trial, coordinated at UofL, included nearly 1500 children in multiple centers across the United States.
The long list of immunizations in the recommended immunization schedule can lead to deferred injections and limit the addition of new vaccines. Depending on which vaccine combinations are used by an individual medical practice, this new vaccine combination may mean an infant receives 1 to 4 fewer injections.
"It has gotten complicated because there are so many vaccines, which is good news because there are fewer sick children. Having combination vaccines is more good news -- it makes things simpler without compromising protection," Marshall said. "Hopefully, this vaccine combination will improve coverage rates. Studies show that when you use combination vaccines, more kids get vaccinated on time and by two years of age more are fully protected. When you make it easier, you get better coverage."
A similar hexavalent vaccine has been available in Europe for more than a decade and has resulted in more timely immunizations.
The report in Pediatrics, entitled "Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants," indicates that children who were given the new vaccine developed immunity to the listed diseases equivalent to that received from an existing immunization regimen. The children experienced a slightly higher rate of redness at the injection site and slightly higher rate of self-limited fever following the injections, as compared with the established regimen. Children receiving both the new vaccine and the established regimen were followed for serious adverse health events for six months following the final dose, with no safety signals raised in either of the two groups.
The new vaccine is currently under review by the Food and Drug Administration. After approval, the vaccine will be available for incorporation into the routine childhood schedule.
"Once it is licensed, we can take pride in having brought this new vaccine to the pediatric community and having done our part to simplify the routine immunization schedule," Marshall said.
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