Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Condition: Pertussis; Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Tetany
Intervention: COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 215.0
Sex: All
Minimum age: 10 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 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.