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Post-Marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00304265
  Purpose

Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.

To describe and characterize adverse events occurring after vaccination with COVAXiS or REPEVAX vaccine among two groups:Group 1 - adolescents 10-14 years of age who participated in study 371-03/01 (and thus received a 5th dose of Tripedia vaccine) and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life.


Condition Intervention Phase
Pertussis
Diphtheria
Tetanus
Poliomyelitis
Biological: Immunization with REPEVAX® or COVAXiS™ and IPV Merieux™"
Phase IV

MedlinePlus related topics: Diphtheria Polio and Post-Polio Syndrome Tetanus Whooping Cough
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the safety after administration of COVAXiS™ or REPEVAX®. [ Time Frame: 28 Days post-vaccination ] [ Designated as safety issue: Yes ]

Enrollment: 213
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   10 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible to receive REPEVAX or COVAXiS vaccine, in accord with German recommendations for a booster dose of acellular pertussis vaccine at 9-17 years of age.
  • Signed and dated informed consent or assent form (as applicable) that is obtained prior to the first study intervention.
  • Judged to be in good health on the basis of reported medical history and history-directed physical examination.
  • Plans to remain in the study area for the length of the trial.
  • The participant and a parent or legal guardian can read, write, and understand the documents and all are mentally competent to give assent and consent.
  • If female, not known or suspected to be pregnant at the time of enrollment into the study and is not planning pregnancy during participation in this trial.
  • Either prior participation in study 371-03/01 (Group 1) or a documented history of 3 doses of tetanus, diphtheria and whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life (Group 2).
  • Has access to a telephone.
  • Oral temperature < 38.0 C.

Exclusion Criteria:

  • Pregnancy or nursing a child
  • Known or suspected primary or acquired disease of the immune system (conditions suspected of having an immunologic component such as autoimmune diseases [eg, rheumatoid arthritis or inflammatory bowel disease] will not be excluded unless they meet exclusion criterion 3 or 5).3.
  • Malignancy, allergy immunotherapy, or receiving immunosuppressive therapy (participants who are taking topical and inhaled steroids could be included in the study as would participants on a "short course" of oral steroids, -<7 days, as long as there are not two courses within the previous two weeks prior to vaccination).
  • Receipt of any pertussis, diphtheria or tetanus-containing vaccines within the past 3 years.
  • Any unstable significant underlying chronic disease, including (but not limited to) malignancy, cardiopulmonary disease, renal, endocrinologic, hematologic or hepatic dysfunction.
  • Known impairment of neurologic function or currently active seizure disorder or currently requiring medication for seizures.
  • Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the last 2 years.
  • Receipt of blood products or immunoglobulin within the previous 3 months.
  • Known or suspected allergy to any of the vaccines or vaccine components intended for use in the study.
  • Daily use of non-steroidal anti-inflammatory drugs.
  • Receipt of any vaccine or investigational product within the 30 days prior to enrollment, or planning to receive another vaccine within 28 days after receiving study vaccine.
  • Chemical dependency (eg, alcoholism or intravenous drug use but not including nicotine or caffeine), based on investigator judgment.
  • Known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis, respiratory problems (eg. wheezing, shortness of breath).
  • Any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
  • History of immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving diphtheria, tetanus, or pertussis vaccine.
  • Planned participation in another interventional clinical trial during the present trial period (participation in a related study to evaluate immune responses to this study's vaccination is permitted).
  • Thrombocytopenia or bleeding disorder that would pose a contraindication to an IM vaccination.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304265

Locations
Germany, Lindwurmstrasse 4
Munich, Lindwurmstrasse 4, Germany, D-80337
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc ( Medical Director )
Study ID Numbers: TRI05
Study First Received: March 16, 2006
Last Updated: September 19, 2008
ClinicalTrials.gov Identifier: NCT00304265  
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi-Aventis:
Pertussis,
Diphtheria,
Tetanus,
Poliomyelitis

Study placed in the following topic categories:
Bacterial Infections
Spinal Cord Diseases
Central Nervous System Diseases
Picornaviridae Infections
Whooping Cough
Cough
Degenerative motor system disease
Diphtheria
Tetanus
Motor neuron disease
Whooping cough
Gram-Negative Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Central Nervous System Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Myelitis
Enterovirus Infections
Clostridium Infections
Motor Neuron Disease

Additional relevant MeSH terms:
Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Nervous System Diseases
Central Nervous System Viral Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009