Pentacel is approved for use in infants and children aged 6 weeks to 4 years (prior to fifth birthday) and is administered as a 4-dose series at 2, 4, 6, and 15 to 18 months of age. The first dose may be given as early as 6 weeks of age.

"The FDA approval of Pentacel vaccine is great news for parents and paediatricians who want to reduce the stress of well-baby visits," said Tina Q. Tan, MD, Children's Memorial Hospital, Chicago, Illinois.

"Pertussis disease continues to remain a threat to young infants, who are at the highest risk for severe complications and death. With a 4-dose primary series of Pentacel vaccine, paediatricians can reduce the number of vaccination shots while providing protection against 5 diseases, including pertussis."

The FDA approval is based on the results of multicentre clinical studies conducted in the United States and Canada involving more than 5,000 children who received at least 1 dose of the vaccine.

The immunogenicity and safety of Pentacel were compared to separately administered, single-entity, vaccine formulations. Local and systemic reactions following administration of Pentacel were reported at rates consistent with those of the separately administered vaccines used in each trial.


SOURCE: Sanofi Pasteur

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