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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Norwegian Institute of Public Health
• Treatments: Vaccines

Criteria

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)