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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open Clinical Study to Assess the Immune Response and Safety of a Booster Dose (5th Dose) of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio Given to Healt

Brief 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.

Detailed Summary:
Sponsor: Norwegian Institute of Public Health

Current Primary Outcome: To measure vaccine specific antibody responses after a fifth dose of a combination vaccine against diphteria-tetanus-pertussis-polio. To register local and systemic reactions after vaccination.

Original Primary Outcome: Same as current

Current Secondary Outcome: To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.

Original Secondary Outcome: Same as current

Information By: Norwegian Institute of Public Health

Dates:
Date Received: August 8, 2007
Date Started: April 2007
Date Completion:
Last Updated: August 8, 2007
Last Verified: April 2007