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

This study has been completed.
Sponsor:
Information provided by:
Norwegian Institute of Public Health
ClinicalTrials.gov Identifier:
NCT00514059
First received: August 8, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  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: Endpoint Classification: Safety Study
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.

  Eligibility

Ages Eligible for Study:   15 Years to 16 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00514059     History of Changes
Other Study ID Numbers: SM07-01
Study First Received: August 8, 2007
Last Updated: August 8, 2007
Health Authority: Norway: Norwegian Medicines Agency
Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health
Norway: Data Protection Authority

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

ClinicalTrials.gov processed this record on July 22, 2014