Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00304265
First received: March 16, 2006
Last updated: January 10, 2014
Last verified: January 2014
  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 REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) 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: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reactogenicity of Acellular Pertussis Vaccine Booster in Adolescents Who Have Received 5 Prior Doses of BIKEN Acellular Pertussis Vaccine in Combination With Diphtheria and Tetanus Toxoids (TRIPEDIA®) or Who Have Received Primary Vaccination With 3 Doses of Whole-Cell Pertussis Vaccine, Plus at Least 1 Pertussis Booster Vaccination

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine [ Time Frame: Days 0 to 14 Post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.

    Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.



Enrollment: 215
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6th Dose Pertussis Vaccine Group
Participants received 6th dose of pertussis vaccine
Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
0.5 mL, Intramuscular
Other Names:
  • REPEVAX®
  • COVAXIS™
  • IPV Merieux™
Experimental: 5th Dose Pertussis Vaccine Group
Participants received 5th dose of pertussis vaccine
Biological: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
0.5 mL, Intramuscular
Other Names:
  • REPEVAX®
  • COVAXIS™
  • IPV Merieux™

  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 - 6th Dose Pertussis Vaccine Group) 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 - 5th Dose Pertussis Vaccine Group).
  • Has access to a telephone.
  • Oral temperature < 38.0ºC.

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 [e.g. rheumatoid arthritis or inflammatory bowel disease] will not be excluded unless they meet exclusion criterion 3 or 5).
  • 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 (e.g. 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 (e.g. 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 intramuscular (IM) 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: NCT00304265

Locations
Germany
Munich, Lindwurmstrasse 4, Germany, D-80337
Bielefeld, Germany, D-33611
Detmold, Germany, D-32756
Donzdorf, Germany, D-73072
Grafing, Germany, D-85567
Heilbronn, Germany, D-74072
Lauffen, Germany, D-74348
Marbach, Germany, D-71672
Marktoberdorf, Germany, D-87616
Munich, Germany, D-81247
Munich, Germany, D-80939
Schwandorf, Germany, D-92421
Schwieberdingen, Germany, D-71701
Schwäbisch Hall, Germany, D-74523
Stuttgart, Germany, D-70469
Süßen, Germany, D-73079
Veitshöchheim, Germany, D-97209
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00304265     History of Changes
Other Study ID Numbers: TRI05
Study First Received: March 16, 2006
Results First Received: February 10, 2011
Last Updated: January 10, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Whooping Cough
Tetanus
Diphtheria
Poliomyelitis
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on September 30, 2014