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Trial - EUCTR2021-002789-42-AT


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

First author
Last imported at : May 5, 2022, 4 p.m.
Source : EU Clinical Trials Register

Medizinische Universität Innsbruck - Sponsor and PI

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"}]