E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The intended use of the vaccine in this study is to increase the immunological protection against pertussis in adults who completed primary vaccination with diphtheria, tetanus and pertussis vaccine typically during their childhood. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034738 |
E.1.2 | Term | Pertussis |
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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 demonstrate anti-pertussis toxin (anti-PTx) booster responses in at least 60 % of TdaP booster vaccinated adults, defined from pre- and post-vaccination anti-PTx antibody concentrations.
-To demonstrate the non-inferiority of TdaP compared to Td when given as a booster vaccination to adults, defined from the percentage of subjects with post-vaccination anti-diphtheria antibody concentrations and anti-tetanus antibody concentrations ≥ 0.1 IU/mL
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E.2.2 | Secondary objectives of the trial |
-To describe and compare the safety profiles in TdaP and Td vaccinated subjects.
-To describe pre- and post-vaccination geometric mean concentrations (GMCs) and reverse cumulative distribution curves, from pre- and post-vaccination anti-pertussis toxin (anti-PTx) antibody concentrations in TdaP vaccinated subjects.
-To describe and compare pre- and post-vaccination GMCs and reverse cumulative distribution curves, from pre- and post-vaccination anti-diphtheria and anti-tetanus antibody concentrations in TdaP and Td vaccinated subjects
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Healthy female or male adult of ≥ 18 years of age
2. Completed primary vaccination with diphtheria (D), Tetanus (T) and whole cell pertussis (wP) vaccines in Denmark
3. Signed informed consent
4. Prepared to grant authorised persons access to medical records
5. Likely to comply with instructions
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E.4 | Principal exclusion criteria |
1. Congenital or acquired immunodeficiency or progressive neurologic disease
2. Uncontrolled epilepsy or progressive encephalopathy
3. Previous experience of serious adverse reaction(s) after vaccinations with diphtheria-, tetanus- acellular or whole cell pertussis- vaccines
4. Vaccinated with any diphtheria, tetanus or pertussis toxoid containing vaccine (e.g. Td, TdaP, TdaP-IPV, DTaP, DTaP-IPV or DTaP-IPV/PRP-T) within 5 years before inclusion
5. Vaccinated with any tetanus toxoid, diphtheria toxoid or diphtheria CRM197 protein conjugated vaccine (e.g. Act-HIB®, NeisVac-C®, Prohibit®, Menectra®, Hib-TITER®, Meningitec®, Menjugate® or Prevenar®) within 5 years before inclusion
6. Known tetanus-, diphtheria- or pertussis disease/infection within 5 years before inclusion
7. Known hypersensitivity or history of allergic reactions to any of the active or inactive constituents of the TdaP or Td vaccines
8. Vaccinated with a live or inactivated vaccine within 1 month before inclusion
9. Administration of immune modulating drugs (such as immunoglobulin, systemic corticosteroids, blood products, azathioprine, cyclosporine, infliximab) within 3 months before inclusion
10. Administration of any investigational drug product or vaccine within 1 month before inclusion
11. Females if pregnant or breastfeeding or not willing to use contraception during the trial
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E.5 End points |
E.5.1 | Primary end point(s) |
-Serum anti-PTx antibody concentrations measured in pre-vaccination and one month post-vaccination serum samples by ELISA
-Serum anti-diphtheria antibody concentrations measured in one month post-vaccination serum samples by a Vero Cell Assay
-Serum anti-tetanus antibody concentrations measured in one month post-vaccination serum samples by ELISA
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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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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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Definition of end of trial: when the last subject has been to the last visit |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |