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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00514059
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Norwegian Institute of Public Health
  Purpose

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
Diphtheria Tetanus Pertussis Polio Drug: Boostrix polio Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514059


Locations
Norway
Norwegian Institute of Public Health
Oslo, Norway
Sponsors and Collaborators
Norwegian Institute of Public Health
Investigators
Principal Investigator: Synne Sandbu, Physician Norwegian Institute of Public Health
  More Information

ClinicalTrials.gov Identifier: NCT00514059     History of Changes
Other Study ID Numbers: SM07-01
First Submitted: August 8, 2007
First Posted: August 9, 2007
Last Update Posted: August 9, 2007
Last Verified: April 2007

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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Tetany
Diphtheria
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases