| Trial registration number
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EUCTR2021-003686-36-FI |
Full text link
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003686-36/FI
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First author
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Finnish Defence Forces - Certer for Military Medicine
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Contact
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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heli.siljander@mil.fi
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Registration date
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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2021-07-15
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Recruitment status
Last imported at : Jan. 16, 2025, 4 a.m.
Source : EU Clinical Trials Register
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Completed
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Study design
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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nonRCT
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Allocation
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Non-randomized
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Design
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Single group assignment
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Masking
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Open label
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Center
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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multi-center
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Study aim
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Prevention
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Inclusion criteria
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Eligible individuals
1. Belong to the Finnish Defence Forces' personnel or are undergoing their military service AND
2. Have not yet received vaccinations against COVID-19, but are planning to receive them in the near future AND
3. Have sufficient skills in Finnish AND
4. Are free from conditions that increase blood draw related risks.
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Exclusion criteria
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Exclusion criteria:
Individuals who
1. Do not fulfill inclusion criteria OR
2. Cannot participate in the study as described in the Study Protocol
- Do not understand the study concept
- Cannot give their written informed consent
- Are not willing to give the required information or blood samples
- Have any health related or social situation associated conditions that may worsen if the individual participates in this study.
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Number of arms
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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1
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Funding
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Finnish Defence Forces
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Inclusion age min
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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18
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Inclusion age max
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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65
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Countries
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Finland
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Type of patients
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Healthy volunteers
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Severity scale
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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N/A
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Total sample size
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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200
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primary outcome
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Immune response induced by the SARS-CoV-2 vaccination:
1. Immunoglobulin class M, G and A antibodies (quantitative and qualitative analyses)
2. Neutralizing antibodies (semi-quantitative analyses)
3. Rapid antibody tests vs. conventional serological assessments.
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Notes
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Not reported
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Phase
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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Phase 4
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Arms
Last imported at : March 16, 2023, 4 p.m.
Source : EU Clinical Trials Register
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[{"arm_notes": "Any COVID-19 vaccine", "treatment_id": 1911, "treatment_name": "Covid-19 vaccine", "treatment_type": "Other covid vaccine", "pharmacological_treatment": "Vaccine"}]
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