NCT00514059

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Norwegian Institute of Public Health · Other Government
• Sex: All
• Age: 15 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus
• Pertussis
• Polio

Interventions

Type	Name	Description
DRUG	Boostrix polio	1 dose (0.5 ml) i.m.

Timeline

• Start date: 2007-04-01
• Completion: 2007-06-01
• First posted: 2007-08-09
• Last updated: 2007-08-09

Locations

1 site across 1 country: Norway