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

Phase 4

Completed

• Conditions: Poliomyelitis; Diphtheria; Tetanus; Pertussis

• Registration Number: NCT00304265
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-16
• Study First Submitted QC: 2006-03-16
• Study First Posted: 2006-03-17
• Primary Completion: 2006-10
• Study Completion: 2007-10
• Results First Submitted: 2011-02-10
• Results First Submitted QC: 2011-03-08
• Results First Posted: 2011-04-07
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine	Days 0 to 14 Post-vaccination	Solicited injection site reactions: Pain, Erythema, Swelling, and Arm circumference.; Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.