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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Diphtheria

Tetanus

Pertussis

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00304265

TRI05

Details and patient eligibility

About

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.

Enrollment

215 patients

Sex

All

Ages

10 to 14 years old

Volunteers

Accepts Healthy Volunteers

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.