Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00304265
• Other study ID #: TRI05
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2006
• Last updated: April 12, 2016
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: October 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Germany, 

References & 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. Pe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

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