Diphtheria, Tetanus, and Acellular Pertussis (DTaP) Vaccine

DTaP vaccine protects from diphtheria, tetanus (lockjaw), and pertussis (whooping cough). It is designed to be given in a series of 5 doses. DTaP was first licensed in 1991, and research shows that it is much safer than the previous formulation, DTP. Currently, there are 3 licensed formulations of the DTaP vaccine. Many different clinical trials were conducted on each vaccine to make sure of its safety. Results from clinical trials showed that these vaccines are very safe for infants and children.

Currently, there are 3 licensed DTaP vaccines in the United States:

• DAPTACEL: Before licensure, 8 clinical studies were conducted and a total of 17,577 doses of DAPTACEL vaccine were administered to infants and children. Following clinical studies, the U.S. Food and Drug Administration (FDA) licensed this vaccine in 2002. Since licensed, the most common adverse events reported have been tenderness and redness where the shot was given, headache, diarrhea, and fussiness. To learn more about DAPTACEL, visit FDA.
• Tripedia: In one clinical trial, over 3,000 U.S. infants and 12,000 German infants received one or more doses of Tripedia vaccine as part of the primary immunization series. The clinical trial results showed a reduction in side effects from the previous DTP formulation. FDA licensed this vaccine in 2001. Since licensed, the most common adverse events reported have been soreness where the shot was given, headache, fever, drowsiness, and fussiness. To learn more about Tripedia, visit FDA.
• INFANRIX: Approximately 95,000 doses of INFANRIX were administered in clinical studies. Clinical studies resulted in FDA licensing this vaccine in 1997. Since licensed, the most common adverse events reported have been soreness where the shot was given, headache, dizziness, and severe allergic reaction. To learn more about INFANRIX, visit FDA.

Related Scientific Articles

Benson PJ, Jackson LA, Rees TG, Dunn JB. Changes in DT vaccine frequency and indications for use following introduction of DTaP vaccine. Human Vaccine 2008;493):234-237.

Centers for Disease Control and Prevention (CDC). Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as a five-dose series: supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2000;49(RR13):1-8.

Rosenthal S, Chen R, Hadler S. The safety of acellular pertussis vaccine vs. whole-cell pertussis vaccine: a postmarketing assessment. Arch Pediatr Adolesc Med 1996;150(5):457-460.