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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diphtheria, Tetanus, Pertussis, Polio

Intervention / Treatment
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* Drug: Boostrix polio


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Boostrix polio<br>* 1 dose (0.5 ml) i.m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphteria-tetanus-pertussis-polio vaccine, Booster immunization, Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio), Immunity, Safety