Clinical trial NCT00304265: Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pertussis
Diphtheria
Tetanus
Poliomyelitis
Keywords: Pertussis,
Diphtheria,
Tetanus,
Poliomyelitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 215
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine
timeFrame: Days 0 to 14 Post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
state: Lindwurmstrasse 4
city: Bielefeld
country: Germany
city: Detmold
country: Germany
city: Donzdorf
country: Germany
city: Grafing
country: Germany
city: Heilbronn
country: Germany
city: Lauffen
country: Germany
city: Marbach
country: Germany
city: Marktoberdorf
country: Germany
city: Munich
country: Germany
city: Munich
country: Germany
city: Schwandorf
country: Germany
city: Schwieberdingen
country: Germany
city: Schwäbisch Hall
country: Germany
city: Stuttgart
country: Germany
city: Süßen
country: Germany
city: Veitshöchheim
country: Germany
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.