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

Norwegian Institute of Public Health83 enrolled

Overview

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Diphtheria Tetanus Pertussis Polio

Eligibility

Sex: ALLMin age: 15 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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 Outcomes

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