Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
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
1 other identifier
interventional
215
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2006
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 16, 2006
CompletedFirst Posted
Study publicly available on registry
March 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedResults Posted
Study results publicly available
April 7, 2011
CompletedApril 14, 2016
April 1, 2016
7 months
March 16, 2006
February 10, 2011
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Days 0 to 14 Post-vaccination
Study Arms (2)
6th Dose Pertussis Vaccine Group
EXPERIMENTALParticipants received 6th dose of pertussis vaccine
5th Dose Pertussis Vaccine Group
EXPERIMENTALParticipants received 5th dose of pertussis vaccine
Interventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Pregnancy or nursing a child
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Munich, Lindwurmstrasse 4, D-80337, Germany
Unknown Facility
Bielefeld, D-33611, Germany
Unknown Facility
Detmold, D-32756, Germany
Unknown Facility
Donzdorf, D-73072, Germany
Unknown Facility
Grafing, D-85567, Germany
Unknown Facility
Heilbronn, D-74072, Germany
Unknown Facility
Lauffen am Neckar, D-74348, Germany
Unknown Facility
Marbach, D-71672, Germany
Unknown Facility
Marktoberdorf, D-87616, Germany
Unknown Facility
Munich, D-80939, Germany
Unknown Facility
Munich, D-81247, Germany
Unknown Facility
Schwandorf in Bayern, D-92421, Germany
Unknown Facility
Schwäbisch Hall, D-74523, Germany
Unknown Facility
Schwieberdingen, D-71701, Germany
Unknown Facility
Stuttgart, D-70469, Germany
Unknown Facility
Süßen, D-73079, Germany
Unknown Facility
Veitshöchheim, D-97209, Germany
Related Publications (1)
Liese JG, Rieber N, Malzer T, Ocak M, Johnson DR, Decker MD; Munich Vaccine Study Group. Reactogenicity of tetanus, diphtheria, 5-component acellular pertussis vaccine administered as a sixth consecutive acellular pertussis vaccine dose to adolescents. Pediatr Infect Dis J. 2010 Dec;29(12):1067-71. doi: 10.1097/INF.0b013e3181ea5866.
PMID: 20616762RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2006
First Posted
March 17, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2007
Last Updated
April 14, 2016
Results First Posted
April 7, 2011
Record last verified: 2016-04