post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine

Conditions: Pertussis; Diphtheria; Tetanus; Poliomyelitis

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.


Eligibility 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.

Keywords: pertussis, diphtheria, tetanus, poliomyelitis