Status:
COMPLETED
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Pertussis
Diphtheria
Eligibility:
All Genders
10-14 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00304265
Start Date
March 1 2006
End Date
October 1 2007
Last Update
April 14 2016
Active Locations (17)
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1
Munich, Lindwurmstrasse 4, Germany, D-80337
2
Bielefeld, Germany, D-33611
3
Detmold, Germany, D-32756
4
Donzdorf, Germany, D-73072