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

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ClinicalTrials.gov Identifier: NCT00514059

Recruitment Status : Completed

First Posted : August 9, 2007

Last Update Posted : August 9, 2007

Sponsor:

Information provided by:

Norwegian Institute of Public Health

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Diphtheria Tetanus Pertussis Polio	Drug: Boostrix polio	Phase 4

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	83 participants
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.
Study Start Date :	April 2007
Actual Study Completion Date :	June 2007

Resource links provided by the National Library of Medicine

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

Drug Information available for: Boostrix

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

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
1	Drug: Boostrix polio 1 dose (0.5 ml) i.m.

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted:	August 9, 2007 Key Record Dates
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

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