Profylactic vaccination against diphteria-, tetanus-, pertussis and polio in healthy volunteers 15-16 years old. These volunteers have previously been given a 4th dose of the same vaccine in a clinical trial in 1998, in addition to 3 doses given as part of the Norwegian child immunization program in their first year of life. In the study applied for now, the participants will receive their 5th dose of the vaccine.
Conditions
Interventions
Trade Name: Boostrix Polio
Pharmaceutical Form: Injection*
Sponsors
Norwegian Institute of Public Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy 15-16 years old girls and boys who have received one dose of a vaccine against diphteria, tetanus, pertussis (acellular) and polio in a previous study (VAVA 98-01) in 1998. 2. Written informed consent from the subject and from one parent/guardian, prior to study. 3. The family must be able to understand the information, cooperate and communicate in Norwegian. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any serious chronic disease 2. Vaccination against diphtheria or tetanus during the last 12 months 3. Known or suspected impairment of the immune function (including HIV infection) 4. Immunosuppressive therapy, including cyklosporin, alkylating drugs, anti metabolites, anti lymphocyte globulines, monoclonal antibodies, oral corticosteroids 5. Pregnancy 6. Serious reactiones after previous vaccination with a vaccine against diphtheria, tetanus, pertussis or polio, or any known hypersensitivity to any of the ingredients in the vaccine. 7. Acute fever (axillary temperature = 38°C) at the time the vaccine is given. Vaccination might be postponed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives: To evaluate vaccine specific antibody responses 4 to 8 weeks after a 5th dose of Boostrix Polio is given (vaccination against diphteria-, tetanus-, pertussis and polio). (Analysis of antibodies against diphteria, tetanus, pertussis toxin and polio virus type 1, 2 and 3 will be performed). Safety Objectives: To evaluate the safety of a 5th dose of Boostrix Polio (vaccination against diphteria-, tetanus-, pertussis and polio). ;Secondary Objective: Immunogenicity Objectives: To evaluate the persistence of immune response/antibody responses 8-9 years after a 4th dose of vaccine against diphteria-, tetanus-, pertussis and polio was given. To evaluate antibody responses against other pertussis antigens (other than pertussis toxin) in the vaccine. Possibly, to evaluate antibody responses against other antigens which might be of relevance to the child immunization program.;Primary end point(s): To evaluate the immune response and safety after a 5th vaccine dose (booster dose) of Boostrix Polio, measured by different immunogenicity tests. | — |
Countries
Norway
Outcome results
None listed