E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers |
Gezonde vrijwilligers |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers |
Gezonde vrijwilligers |
|
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 | 23.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084465 |
E.1.2 | Term | COVID-19 vaccination |
E.1.2 | System Organ Class | 100000004865 |
|
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 |
Safety and tolerability of intradermal vaccination of COVID-19 Vaccine Moderna |
Veiligheid van intradermale vaccinatie van COVID-19 Vaccin Moderna |
|
E.2.2 | Secondary objectives of the trial |
Immunogenicity of intradermal vaccination of COVID-19 Vaccine Moderna |
immunogeniciteit van intradermale vaccinatie van COVID-19 Vaccin Moderna |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age: 18 years or older |
leeftijd van 18 jaar of ouder |
|
E.4 | Principal exclusion criteria |
immunocompromised in any way pregnancy |
immuungecompromitteerd zwangerschap
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability of intradermal injection of low dose COVID-19 Vaccine Moderna |
Veiligheid van intradermale injectie met COVID-19 Vaccin Moderna |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
f1rst week after every vaccination |
eerste week na elke vaccinatie |
|
E.5.2 | Secondary end point(s) |
Immunogenicity after low dose intradermale vaccination of COVID-19 Vaccine Moderna |
immunogeniciteit na lage dosis intradermale vaccinatie met COVID-19 Vaccin Moderna |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
On D0 (before vaccination), D29 (time point after the first dose, on the day of the second vaccination), and on D36, D43, Month 7 and Month 13 (time points after the second dose) |
Op D0 (voor vaccinatie), D29 (na de eerste vaccinatie, op de dag van de tweede vaccinatie), en op D36, D43, maand 7 en maand 13 (tijdspunten na de tweede vaccinatie) |
|
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 | 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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | Yes |
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) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
reguliere dosis intramusculaire injectie |
regular dose intramuscular injection |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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
|
LVLS |
Laatste bezoek van laatste deelnemer |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |