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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00514059
Other study ID # SM07-01
Secondary ID
Status Completed
Phase Phase 4
First received August 8, 2007
Last updated August 8, 2007
Start date April 2007
Est. completion date June 2007

Study information

Verified date April 2007
Source Norwegian Institute of Public Health
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsNorway: Directorate of HealthNorway: Data Protection Authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years to 16 Years
Eligibility 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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Boostrix polio
1 dose (0.5 ml) i.m.

Locations

Country Name City State
Norway Norwegian Institute of Public Health Oslo

Sponsors (1)

Lead Sponsor Collaborator
Norwegian Institute of Public Health

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
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