E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Booster vaccination against diphtheria, tetanus and pertussis diseases in adults |
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MedDRA Classification |
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 demonstrate that a booster dose of dTpa vaccine, administered to young adults 10 years after a previous dose of the dTpa vaccine, elicits seroprotective antibody concentrations in at least 80% of the subjects against diphtheria and in at least 90% of the subjects against tetanus one month after the booster dose. The criteria for meeting the above objective are defined as: One month after the booster dose, in subjects who had received Boostrix™ in the study 263855/004 (dTpa-004), • For the diphtheria antigen, the lower limit of the 95% confidence interval (CI) for the percentage of seroprotected (anti-diphtheria antibody concentrations >=0.1 IU/ml by ELISA) subjects is above 80%. • For the tetanus antigen, the lower limit of the 95% CI for the percentage of seroprotected (anti-tetanus antibody concentrations >= 0.1 IU/ml) subjects is above 90%.
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E.2.2 | Secondary objectives of the trial |
• To assess the persistence of anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibodies in young adults 10 years after the previous booster dose in study 263855/004 (dTpa-004). • To assess the immunogenicity of the dTpa vaccine in terms of antibody response to all vaccine antigens one month after the booster vaccination. • To evaluate the safety and reactogenicity of the dTpa vaccine in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. • Subjects who have received dTpa vaccine or Td and pa vaccines in study 263855/004 (dTpa-004) study. • A male or female subject, recruited 10 years (+/- 9 months) after booster vaccination in study 263855/004 (dTpa-004). • If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must use adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series. Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or other barrier method (condom or occlusive cap). • Written informed consent obtained from the subject.
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E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed. • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination. or planned administration during the active study period (up to Visit 2). • Previous booster vaccination against tetanus, diphtheria or pertussis since the last dose received in study 263855/004 (dTpa-004). • History of documented diphtheria, tetanus, or pertussis diseases. • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination (no laboratory testing required). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Seroprotection status one month after the booster dose in the dTpa Group: • Anti-diphtheria antibody concentrations >= 0.1 IU/ml by ELISA. • Anti-tetanus antibody concentrations >=0.1 IU/ml. |
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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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
persistence of antibodies |
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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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |