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

Tetanus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514059
• Other study ID #: SM07-01
• 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
• 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

• Diphtheria
• Pertussis
• Polio
• Poliomyelitis
• Tetanus
• Whooping Cough

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.