E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active immunization against tetanus, diphtheria and pertussis |
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E.1.1.1 | Medical condition in easily understood language |
Protection against tetanus, diphtheria and pertussis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054129 |
E.1.2 | Term | Diphtheria immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069577 |
E.1.2 | Term | Pertussis immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054131 |
E.1.2 | Term | Tetanus immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide safety data on revaccination with ADACEL vaccine |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Previously received ADACEL vaccine as part of Aventis Pasteur studies Td501, Td502, or Td505.
2) At least 15 but no greater than 69 years of age at the time of vaccination in this trial.
3) Signed Institutional Review Board (IRB)-approved informed assent / consent form.
4) Able to attend all scheduled visits and to comply with all trial procedures.
5) For a woman, inability to become pregnant or negative serum/urine pregnancy test. |
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E.4 | Principal exclusion criteria |
1) 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.
2) Serious chronic disease (eg, cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or that might:
• interfere with the ability to participate fully in the study; or
• interfere with evaluation of the vaccine.
3) Known or suspected impairment of immunologic function.
4) Febrile illness within the last 72 hours or an oral temperature ≥100.4°F (≥38°C) at the time of inclusion.
5) History of documented tetanus, diphtheria or pertussis disease within the preceding 5 years.
6) Known or suspected receipt of a tetanus-, diphtheria- or pertussis-containing vaccine since participation in Study Td501, Td502, or Td505. (Receipt of Menactra vaccine at any time prior to the present study is permitted, subject to the next exclusion criterion).
7) Received any vaccine, other than influenza vaccine, in the 28-day period prior to enrollment or scheduled to receive any vaccine, other than influenza vaccine, in the 28-day period after enrollment. For influenza vaccine only, defer if received in the 14-day period prior to enrollment or scheduled to receive in the 14-day period after enrollment.
8) Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting less than 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to
enrollment.
9) Suspected or known hypersensitivity to any of the vaccine components or to latex.
10) Unable to attend the scheduled visits or to comply with the study procedures.
11) In females of childbearing potential, a positive or equivocal urine pregnancy test
at enrollment.
12) Nursing mother.
13) Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
14) Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial visits or procedures.
15) Thrombocytopenia or bleeding disorder contraindicating IM vaccination.
16) Subject deprived of freedom by an administrative or court order, or under the stress of an emergency setting, or hospitalized without his/her consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Occurrence, time to onset, number of days of occurrence, severity, and seriousness of solicited (prelisted in the subject diary and case report form [CRF]) injection site reactions and systemic reactions occurring through 14 days after vaccination.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination, and seriousness of unsolicited adverse events occurring through Visit 2.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination, and seriousness of new-onset, medically-attendeda unsolicited adverse events occurring from Visit 2 through 6 months after vaccination.
• Occurrence, nature (MedDRA preferred term), time to onset, duration, outcome, and relationship to vaccination of serious adverse events (SAEs) through 6 months after vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Vaccination
20 minutes after Adacel vaccination: monitored for immediate reactions
Post-vaccination
Visit 1(Day 14): record unsolicited reactions from vaccination until Day 14
Visit 2 (28 days): record unsolicited reactions from Day 14 to to Day 28
Safety Follow-up
Visit 2 until 6 months: record new-onset, medically-attended unsolicited adverse events from Visit 2 through 6 months after vaccination; and record SAEs for 6 months |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 11 |