drugset / Trial / NCT00514059

Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine

NCT00514059

Phase 4 Completed 83 enrolled Norwegian Institute of Public Health
NaSingle-groupOpen-labelPrevention

Summary

An open clinical trial to study the immune response and safety after giving a booster dose (5th Dose) of a combination vaccine against Diphteria-Tetanus-Pertussis-Polio to healthy adolescents 15-16 Years of age. The first three doses were given during the first year of life, according to the Norwegian child immunization program. The fourth dose was given in a previous clinical trial performed in 1998 when the children were 6-7 years old. In 2006 there was a change in the child immunization program in Norway: a fourth dose of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio is given to children 6-7 years old. This study will give us information if there is need for an additional dose (5th dose) of a combination vaccine, containing the pertussis components, before the adolescents are leaving secondary school.

Timeline

Start
2007-04
Primary completion
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Boostrix Polio Vaccine 0.5 ml Intramuscular