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

NCT ID: NCT00514059

Last Updated: 2007-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diphtheria Tetanus Pertussis Polio

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Boostrix polio

Intervention Type DRUG

1 dose (0.5 ml) i.m.

Interventions

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Boostrix polio

1 dose (0.5 ml) i.m.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

15 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Synne Sandbu, Physician

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

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Norwegian Institute of Public Health

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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SM07-01

Identifier Type: -

Identifier Source: org_study_id