Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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 Healthy Adolescents 15-16 Years of Age.|
- 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.
- To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
|Study Start Date:||April 2007|
|Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514059
|Norwegian Institute of Public Health|
|Principal Investigator:||Synne Sandbu, Physician||Norwegian Institute of Public Health|