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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Study of Swelling and Other Reactions to Evaluate Safety of Diptheria-Tetanus-Acellular Pertussis Vaccine

Principal Investigator: Emily Jane Woo
Office / Division: OBE / DE

Public Health Issue: Pertussis (whooping cough) is increasing in adolescents and can cause death or other serious illness in infants. Health officials recommend that children receive a fifth dose of the diphtheria-tetanus-acellular pertussis (DTaP) vaccines when they begin school. However, a few children experience severe swelling reactions to this dose of the vaccine. The FDA is studying some of these children to see how many of them experience severe swelling after the fifth dose and whether their risk of swelling relates to the children's immune responses, size, and other symptoms (such as fever).

Regulatory Contribution: Even though many doctors already give children a fifth dose, the FDA has not yet approved this use. It is important to know whether giving a fifth dose will cause severe swelling and other symptoms, and to know which children are at the greatest risk for having these reactions. If the FDA approves the fifth dose, it might recommend that the manufacturer include in the package insert a statement to tell doctors which children have the greatest risk of swelling after the fifth dose.

Research Approach: In this research program, children who had severe swelling after the fourth dose of DTaP vaccine will receive a fifth dose. Researchers will study swelling, pain, redness, and warmth at the injection site, as well as fever and immune responses. This effort includes examining children before and after immunization, administering the vaccine, communicating with parents about symptoms, and conducting serological tests.

Mission Relevance and Outcomes: This study will provide knowledge about the safety of DTaP vaccine.

Vaccine 2006 Mar 24;24(14):2685-91
Adverse events after hepatitis A B combination vaccine.
Woo EJ, Miller NB, Ball R; VAERS Working Group

Pharmacoepidemiol Drug Saf 2005 Sep;14(9):601-9
Comparing data mining methods on the VAERS database.
Banks D, Woo EJ, Burwen DR, Perucci P, Braun MM, Ball R

Pediatrics 2005 Feb;115(2):453-60
Adverse events after inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990-2003.
McMahon AW, Iskander J, Haber P, Chang S, Woo EJ, Braun MM, Ball R

Vaccine 2005 Jan 19;23(9):1097-8
Photophobia following smallpox vaccination.
McMahon AW, Bryant-Genevier MC, Woo EJ, Braun MM, Ball R


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