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 |
1. To compare the immunogenicity of the tetanus and lower dose diphtheria toxoids of ADACEL™ with QUADRACEL™ when given as a fifth dose.
2. To compare the redness, swelling, pain, and fever rates after the ADACEL™ dose with the rates of these adverse events observed after the QUADRACEL™ dose when given as a fifth dose.
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E.2.2 | Secondary objectives of the trial |
1. To assess the immunogenicity of diphtheria and tetanus toxoids in terms of GMTs and four-fold rises in both treatment groups.
2. To assess the immunogenicity of all pertussis antigens in terms of GMTs and four-fold rises in both treatment groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A subject must meet all the following criteria in order to be included in the study:
1. Age > 4 years and < 7 years.
2. Signed and dated IRB approved informed consent form obtained prior to the first study intervention.
3. Judged to be in good health on the basis of reported medical history and examination.
4. Plans to remain in the study area for the length of the trial.
5. Parent or legal guardian can read and write English/French and can understand the informed consent documents and the study instructions and is mentally competent to give consent.
6. Parent or legal guardian has access to a telephone.
7. Has documentation of complete primary series and fourth dose, consisting of exactly four previous administrations of the pentavalent HCPDT-mIPV/PRP-T vaccine (PENTACEL™).
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E.4 | Principal exclusion criteria |
A subject who meets any of the following criteria will not be eligible for inclusion in the study:
1. Known or suspected primary or acquired disease of the immune system, including autoimmune diseases such as rheumatoid arthritis or inflammatory bowel disease.
2. Any unstable, significant underlying chronic disease, including, but not limited to, malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder.
3. Receipt of immunosuppressive therapy for chronic immune disorders or malignancy.
4. Daily use of oral or inhaled corticosteroids for any medical conditions: e.g. daily systemic prednisone > 1 mg/kg (However, topical corticosteroids or inhaled corticosteroids that are taken on an occasional basis, or for < 7 days, as long as there are not two courses within the previous two weeks prior to vaccination, are not an exclusion criterion.).
5. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).
6. Seizures disorder due to epilepsy or any other known neurologic impairment, whether active or medically controlled.
7. Any other condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
8. Receipt of any other vaccine or of allergy shots within the past 30 days, or planning to receive another vaccine or allergy shots before completion of the study.
9. Receipt of an investigational product as part of another clinical trial within the past 30 days, or planning to receive another investigational product before completion of the study.
10. Receipt of blood products or immunoglobulin within the past 3 months.
11. Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months.
12. Known or suspected allergy to any of the vaccines or vaccine components intended for use in the study.
13. Previous severe reactions to any of the vaccines used in this study, including anaphylaxis immediately following the vaccine, seizure within 3 days of receiving the vaccine, or encephalopathy within 7 days of receiving the vaccine.
Temporary Contraindications for All Immunizations (the dose will be deferred)
A subject who meets either of the following criteria at the time of planned vaccination will have enrollment deferred until complete resolution of symptoms:
1. Oral temperature > 38.0 degrees C
2. Known or suspected acute infectious respiratory illness, with one or more of the following active symptoms and signs: rhinorrhea, new cough, pharyngitis, and respiratory problems (e.g., wheezing, shortness of breath).
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E.5 End points |
E.5.1 | Primary end point(s) |
Expected Response Levels for Diphtheria and Tetanus clinical endpoints:
Antigen Primary Clinical Endpoints Expected Response Levels Power (95% CI with N=600) Diphtheria IU/mL % > = 0.1 98% 98% Tetanus IU/mL % > = 0.1 99% 98%
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety Post-Vaccination: Day 0 to day 14 post-vaccination or until resolution and until study completion (4–6 weeks after vaccination).
Immunogenicity Pre-Vaccination and Post-Vaccination 4 to 6 weeks: Antibody levels for diphtheria, tetanus, and pertussis
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E.5.2 | Secondary end point(s) |
Safety: The occurrence, intensity and relationship to vaccination of adverse events (AEs) reported within the first 24 hours and 72 hours. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Severe Redness (>= 3.5 cm) - Within first 24 hours
Any Redness - Within first 72 hours
Severe Swelling (>= 3.5 cm) - Within first 24 hours
Any Swelling - Within first 72 hours
Pain - Within first 72 hours
Fever (>= 38 degrees C) - Within first 24 hours
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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 | Yes |
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) | Yes |
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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |