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

This study has been completed.
Sponsor:
Information provided by:
Norwegian Institute of Public Health
ClinicalTrials.gov Identifier:
NCT00514059
First received: August 8, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

August 8, 2007
August 8, 2007
April 2007
Not Provided
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.
Same as current
No Changes Posted
To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
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.

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Pertussis
  • Polio
Drug: Boostrix polio
1 dose (0.5 ml) i.m.
1
Intervention: Drug: Boostrix polio
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
June 2007
Not Provided

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)
Both
15 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00514059
SM07-01
No
Not Provided
Norwegian Institute of Public Health
Not Provided
Principal Investigator: Synne Sandbu, Physician Norwegian Institute of Public Health
Norwegian Institute of Public Health
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP