Diphtheria, Pertussis, Polio, Tetanus
Conditions
Keywords
Diphteria-tetanus-pertussis-polio vaccine, Booster immunization, Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio), Immunity, Safety
Brief 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.
Interventions
DRUGBoostrix polio
1 dose (0.5 ml) i.m.
Sponsors
Norwegian Institute of Public Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 16 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio. | — |
Countries
Norway
Outcome results
None listed