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

This study has been completed.
Information provided by:
Norwegian Institute of Public Health Identifier:
First received: August 8, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

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.

Condition Intervention Phase
Drug: Boostrix polio
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Norwegian Institute of Public Health:

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.

Enrollment: 83
Study Start Date: April 2007
Study Completion Date: June 2007
Arms Assigned Interventions
1 Drug: Boostrix polio
1 dose (0.5 ml) i.m.


Ages Eligible for Study:   15 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)
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Please refer to this study by its identifier: NCT00514059

Norwegian Institute of Public Health
Oslo, Norway
Sponsors and Collaborators
Norwegian Institute of Public Health
Principal Investigator: Synne Sandbu, Physician Norwegian Institute of Public Health
  More Information Identifier: NCT00514059     History of Changes
Other Study ID Numbers: SM07-01
Study First Received: August 8, 2007
Last Updated: August 8, 2007

Keywords provided by Norwegian Institute of Public Health:
Diphteria-tetanus-pertussis-polio vaccine
Booster immunization
Vaccine effect (Diphtheria-tetanus-acellular pertussis-polio)

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases processed this record on May 23, 2017