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Column | Value |
---|---|
Trial registration number | EUCTR2021-002789-42-AT |
Full text link
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002789-42/AT |
First author
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
|
Contact
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
mui-sponsor@i-med.ac.at |
Registration date
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
2021-07-07 |
Recruitment status
Last imported at : Feb. 1, 2025, 8 a.m. Source : EU Clinical Trials Register |
Terminated |
Study design
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
nonRCT |
Allocation
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Non-randomized |
Design
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Parallel |
Masking
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Open label |
Center
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
single-center |
Study aim
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Prevention |
Inclusion criteria
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Inclusion criteria: 1. Age (≥ 18 years) 2. Decision-making male and female Subjects 3. Has there been influenza, or SARS-CoV-2, or Pneumococcal vaccination (collective 1 + 2) or already fixed vaccination date with an influenza, or SARS-CoV-2, or pneumococcal vaccination (Collective 1) 4. Written, signed and dated Declaration of consent to participate in the clinical examination after prior written and oral explanation 5. Only applicable to subjects in collective 1: negative urine / serum pregnancy test Women of childbearing age |
Exclusion criteria
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Exclusion criteria 1. The subject is a presence or Training service provider 2. Parallel vaccination with a second vaccine within ± 14 days 3. Participation in an interventional study in the active phase 4. Only applicable to subjects in collective 1: Breastfeeding period |
Number of arms
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
3 |
Funding
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Medizinische Universität Innsbruck |
Inclusion age min
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
18 |
Inclusion age max
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
100 |
Countries
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Austria |
Type of patients
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Healthy volunteers |
Severity scale
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
N/A |
Total sample size
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
1000 |
primary outcome
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Association between immunological and laboratory parameters and the Immune response. |
Notes
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Declared number of arm (1.0) differs from found arms (3.0) |
Phase
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
Phase 4 |
Arms
Last imported at : May 5, 2022, 4 p.m. Source : EU Clinical Trials Register |
[{"arm_notes": null, "treatment_id": 1162, "treatment_name": "Sars-cov-2 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": null, "treatment_id": 1006, "treatment_name": "Pneumococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": null, "treatment_id": 2414, "treatment_name": "Influenza vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |