Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Pertussis,, Diphtheria,, Tetanus,, Poliomyelitis
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.
Interventions
BIOLOGICALCOVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Participant flow
Recruitment details
Participants were enrolled from February 2006 to July 2006 at 17 clinical sites in Germany.
Pre-assignment details
A total of 214 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. One over aged participant was also vaccinated and included in the safety analysis.
Participants by arm
| Arm | Count |
|---|---|
| 6th Dose Pertussis Vaccine Group Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents. | 117 |
| 5th Dose Pertussis Vaccine Group Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents. | 98 |
| Total | 215 |
Baseline characteristics
| Characteristic | 5th Dose Pertussis Vaccine Group | 6th Dose Pertussis Vaccine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 98 Participants | 117 Participants | 215 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 12.6 Years FULL_RANGE 0 | 12.3 Years FULL_RANGE 0 | 12.4 Years FULL_RANGE 0 |
| Region of Enrollment Germany | 98 Participants | 117 Participants | 215 Participants |
| Sex: Female, Male Female | 37 Participants | 55 Participants | 92 Participants |
| Sex: Female, Male Male | 61 Participants | 62 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 117 | 87 / 97 |
| serious Total, serious adverse events | 0 / 117 | 0 / 98 |
Outcome results
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.
Time frame: Days 0 to 14 Post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Pain | 85 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Systemic Reactions After Vaccination | 85 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Swelling | 24 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Fever | 5 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Erythema | 19 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Headache | 40 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Swelling (> 5.0 cm) | 6 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Headache (Prevents Daily Activities) | 4 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Pain (Incapacitating) | 7 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Malaise | 40 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Increase in Arm Circumference | 8 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 2 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Erythema (> 5.0 cm) | 10 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Myalgia | 69 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Increase in Arm Circumference (> 5.0 cm) | 0 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Myalgia (Prevents Daily Activity) | 5 Participants |
| 6th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Local Reactions After Vaccination | 89 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Myalgia (Prevents Daily Activity) | 10 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Local Reactions After Vaccination | 87 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Pain | 87 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Pain (Incapacitating) | 8 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Erythema | 27 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Erythema (> 5.0 cm) | 10 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Swelling | 17 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Swelling (> 5.0 cm) | 8 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Increase in Arm Circumference | 11 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Increase in Arm Circumference (> 5.0 cm) | 0 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Systemic Reactions After Vaccination | 84 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Fever | 15 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Headache | 50 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Headache (Prevents Daily Activities) | 5 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Malaise | 44 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Grade 3 Malaise (Prevents Daily Activities) | 2 Participants |
| 5th Dose Pertussis Vaccine Group | Number of Participants Reporting a Solicited Local or Systemic Reaction Post-Vaccination With Either REPEVAX® or COVAXIS® Vaccine | Any Myalgia | 73 Participants |