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
|
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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 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 |

Arm | Intervention/treatment |
---|---|
1 |
Drug: Boostrix polio
1 dose (0.5 ml) i.m.
|
- 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.
- To measure vaccine specific antibody responses approximately eight years after a fourth dose of a combination vaccine against diphteria-tetanus-pertussis-polio.

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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)

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
Norway | |
Norwegian Institute of Public Health | |
Oslo, Norway |
Principal Investigator: | Synne Sandbu, Physician | Norwegian Institute of Public Health |
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 |