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

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:

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough

Genetic and Rare Diseases Information Center resources: Whooping Cough Tetanus Diphtheria Poliomyelitis Myelitis

U.S. FDA Resources

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 (Child)
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


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:


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

ClinicalTrials.gov processed this record on September 23, 2016