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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:
Norwegian Institute of Public Health
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
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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: 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:
Drug Information available for:
Boostrix
Genetic and Rare Diseases Information Center resources:
Diphtheria
Poliomyelitis
Whooping Cough
Tetanus
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) |
| 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
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
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 |
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 July 21, 2017