Brief Summary

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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."

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 Type: Interventional
• Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Interventions Used in this Clinical Trial

• Drug: Boostrix polio
  • 1 dose (0.5 ml) i.m.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Outcome Measures for this Clinical Trial

Primary Measures

• 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.

Secondary Measures

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

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Healthy adolescents who have previously received a dose of a vaccine against diphteria, tetanus, pertussis and polio in a clinical trial in 1998
• Written informed consent from the adolescent and one of his/her parents
• The family must understand norwegian

Exclusion Criteria

• Serious chronic diseases
• Vaccination against tetanus last 12 months
• Immunization with a Diphteria vaccine component after the study in 1998
• Suspected or confirmed immune deficiency
• Immunological/immunosuppressive treatment
• Pregnancy
• Serious reactions to previous immunization with any of the vaccine components
• Acute fever (axillary temperature ≥ 38°C) at the the of vaccination. (Postpone vaccination)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 15 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

• Lead Sponsor
  • Norwegian Institute of Public Health
• Overall Official(s)
  • Synne Sandbu, Physician, Principal Investigator, Norwegian Institute of Public Health