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

Norwegian Institute of Public Health

Status and phase

Completed

Phase 4

Conditions

Diphtheria

Polio

Pertussis

Tetanus

Treatments

Drug: Boostrix polio

Study type

Interventional

Funder types

Other

Identifiers

NCT00514059

SM07-01

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

15 to 16 years old

Volunteers

Accepts Healthy Volunteers

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)