E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunogenicity of the consecutive vaccination with both an mRNA COVID-19 vaccin and Influenza vaccin, in different sequences |
Immunogenicitteit van de opeenvolgende vaccinatie met een mRNA COVID-vaccin en influenza vaccin, in verschillende volgorden |
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E.1.1.1 | Medical condition in easily understood language |
Immunological effects of different sequences of vaccinating against COVID-19 and the flu |
Immunologisch effect van verschillende volgorden van vaccineren tegen COVID-19 en de griep |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 |
Aim 1. To study the impact of different sequences of combined influenzaand SARS-CoV-2 vaccinations on immunological responses and side effects. Aim 2. To understand the immunological mechanisms that mediate the potential interference between influenza and COVID-19 vaccines, and the long-term effects of this interaction. |
Doel 1. Het bestuderen van de impact van verschillende volgorden van influenza- en SARS-CoV-2 vaccinaties op de immunologische response en bijwerkingen. Doel 2. Het begrijpen van de immunologische mechanismen die de potentiële interferentie tussen influenza- en COVIDvaccins mediëren, en de lange termijn effecten van deze interactie. |
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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 |
Age equal to or above 18 years No previous COVID-vaccine Healthy (=no chronic disease or medication use) |
Leeftijd gelijk aan of groter dan 18 jaar Geen eerdere COVID-vaccinatie Gezond (=geen chronische ziekte of medicatie) |
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E.4 | Principal exclusion criteria |
History of COVID-19 infection, confirmed by a microbiological test Vaccinated against influenza in the past 6 months
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Doorgemaakte COVID-19 infectie, bewezen met een microbiologische test Gevacineerd tegen influenza <6 maanden |
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E.5 End points |
E.5.1 | Primary end point(s) |
Geometric mean concentrations (GMCs) of RBD- and S-specific IgG, IgA and IgM in serum at 28 days after last vaccination. |
Gemiddelde concentratie van RBD- en S-specifiek IgG, IgA en IgM in serum, 28 dagen na laatste vaccinatie |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28days after last vaccination |
28dagen na laatste vaccinatie |
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E.5.2 | Secondary end point(s) |
Seroconversion of IgG to the SARS-CoV-2 spike protein at day 28 after the first dose of COVID-19 vaccines. - Virus neutralization assays for the standard SARS-CoV-2 variant, as well as for the B1.1.7 and B1.351 variants - IgG, IgA and IgM concentrations against SARS-CoV-2 and influenza antigens in nasal mucosal lining fluid at the various sampling time points. - Specific anti-SARS-CoV-2 T-cell responses against standard SARSCoV- 2 variant, as well as for the B1.1.7 and B1.351 variants - Local reactions at injection site or systemic reactions after vaccination - Serious adverse events and other adverse events |
- Seroconversie van IgG naar SARS-CoV-2 spike eiwit, 28 dagen na de eerste dosis COVID-19 vaccinatie. - Virus neutralisatie tests voor de standaard SARS-CoV-2 variant, de B1.1.7 en B1.351 variant - IgG, IgA en IgM concentraties tegen SARS-CoV-2 en influenza antigenen in neusslijmvlies op verschillende tijdspunten - Specifieke anti-SARS-CoV-2 T-cell reacties tegen de standaard SARSCoV- 2 variant, B1.1.7 en B1.351 variant - Lokale of systemische reacties na vaccinatie - SAE's en AE's |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 28, day 56, day 84, day 236 |
Dag 28, 56, 84, 326 |
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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 | No |
E.6.6 | Pharmacokinetic | Yes |
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 | 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 |
We vergelijken "COVID-vaccin eerst, daarna influenza-vaccin" met "Influenza vaccin eerst, dan COVID" |
We compare "COVID-vaccine first, influenza vaccine 2nd" to "Influenza vaccine 1st, COVID-vaccin 2nd" |
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E.8.2.4 | Number of treatment arms in the trial | 8 |
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 | 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
|
The study ends after the last blood/MLF collection. This timepoint is 6 months after last vaccination. |
De studie eindigt na de laatste bloed-/MLF afname. Dat bezoek vindt 6 maanden na de laatste vaccinatie plaats. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |