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U.S. FDA Licenses DAPTACEL(R) Vaccine for the Fifth Consecutive Dose in the Pediatric DTaP Immunization Series
Date:3/13/2008

n-compliance, and 1 withdrew voluntarily. None of the children involved in the study withdrew as a result of an adverse event or contraindication. Additionally, the majority of solicited local and systemic reactions occurred within 3 days of immunization and were considered to be of mild or moderate severity.

Following administration of DAPTACEL vaccine as the fifth dose, more than 93 percent of subjects experienced a booster response to each of the pertussis components. Additionally, all participants (100 percent) achieved antibody responses greater than or equal to 0.1 IU/mL for both the tetanus and diphtheria antigens, indicating that protective levels had been achieved. In assessing long-term protection, the study found that 99.6 percent (250/251) and 98.8 percent (248/251) of subjects achieved levels greater than or equal to 1.0 IU/mL for diphtheria and tetanus, respectively.

About DAPTACEL Vaccine

DAPTACEL vaccine is given to infants and children 6 weeks through 6 years (prior to 7th birthday) to prevent 3 serious diseases: diphtheria, tetanus (lockjaw), and pertussis (whooping cough). As with any vaccine, vaccination with DAPTACEL vaccine may not protect 100 percent of individuals. There are risks associated with all vaccines. The most common side effects with DAPTACEL vaccine are redness, swelling, and soreness or tenderness where the injection was given; fever, fussiness, and crying more than usual. Other side effects may occur. DAPTACEL vaccine should not be given to children who, after a previous dose of the vaccine, have had a serious allergic reaction (anaphylactic reaction) or encephalopathy not attributable to another cause.

For more information about DAPTACEL vaccine, refer to the Patient Information on DAPTACEL.com and talk to your child's health-care provider.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve th
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