Back to resultsImmunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
Primary Purpose
Diphtheria, Tetanus, Pertussis
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Boostrix polio
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Diphteria-tetanus-pertussis-polio vaccine, Booster immunization, Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio), Immunity, Safety
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)
Sites / Locations
- Norwegian Institute of Public Health
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
Full Information
NCT ID
NCT00514059
First Posted
August 8, 2007
Last Updated
August 8, 2007
Sponsor
Norwegian Institute of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT00514059
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Norwegian Institute of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis, Polio
Keywords
Diphteria-tetanus-pertussis-polio vaccine, Booster immunization, Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio), Immunity, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Boostrix polio
Intervention Description
1 dose (0.5 ml) i.m.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Synne Sandbu, Physician
Organizational Affiliation
Norwegian Institute of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian Institute of Public Health
City
Oslo
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of a Booster Dose (5th) of Diphteria-Tetanus-Pertussis-Polio Vaccine
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