FDA approves five-in-one vaccine

June 24, 2008

The Food and Drug Administration has approved a new single vaccine for immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b, according to officials at sanofi pasteur.

The Food and Drug Administration has approved a new single vaccine for immunization against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b, according to officials at sanofi pasteur.

The five-in-one vaccine, called Pentacel, is administered in four doses, scheduled between 2 and 18 months. The initial dose may be given as early as six weeks, and the full course should be finished before the patient?s fifth birthday.

The Pentacel vaccine consists of two parts, containing the diphtheria and tetanus toxoids, acellular pertussis adsorbed, and inactivated poliovirus (DTaP-IPV), and Haemophilus b Conjugate Vaccine (ActHIB). Children who receive the full vaccine should also get a fifth dose of DTaP before their sixth birthday.

In clinical trials, 5,980 participants were administered one dose of the vaccine, including about 4,200 who were studied regarding the safety of four consecutive doses. Adverse events varied from 3.4% to 0.3% across the trials. The most reported events were bronchiolitis, dehydration, and gastroenteritis.

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