Brief Title
Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
Official Title
Open Clinical Study to Assess the Immune Response and Safety of a Booster Dose (5th Dose) of a Combination Vaccine Against Diphteria-Tetanus-Pertussis-Polio Given to Healthy Adolescents 15-16 Years of Age.
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
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 Outcome
To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
Condition
Diphtheria
Intervention
Boostrix polio
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
83
Start Date
April 2007
Completion Date
June 2007
Eligibility 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)
Gender
All
Ages
15 Years - 16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Synne Sandbu, Physician, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT00514059
Organization ID
SM07-01
Study Sponsor
Norwegian Institute of Public Health
Study Sponsor
Synne Sandbu, Physician, Principal Investigator, Norwegian Institute of Public Health
Verification Date
April 2007