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Analysis and characterization of the immune response after influenza, SARS-CoV-2 and pneumococcal vaccinations (IMMUNE Study)

Analysis and characterization of the immune response after influenza, SARS-CoV-2 and pneumococcal vaccinations (IMMUNE Study)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-002789-42-AT
Enrollment
1000
Registered
2021-07-07
Start date
2021-07-08
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analysis and characterization of the immune response after influenza, SARS-CoV-2 and pneumococcal vaccinations (IMMUNE Study)

Interventions

Product Name: Covid-19 vaccine Pharmaceutical Form: Dispersion for injection Product Name: Influenza vaccine Pharmaceutical Form: Suspension for injection Product Name: Pneumococcal vaccine Pharmace

Sponsors

Medizinische Universität Innsbruck
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Main Objective: The aim of the study is the immune response (Antibody titre, B- and T-cell immunity) of different Patient groups and healthy volunteers after Influenza, SARS-CoV-2 and pneumococcal vaccinations too examine. ;Secondary Objective: Primary endpoint: immune response (antibody titre, B and T cell immunity) Secondary endpoint: association between immunological and laboratory parameters and the Immune response ;Primary end point(s): Association between immunological and laboratory parameters and the Immune response. ;Timepoint(s) of evaluation of this end point: -

Secondary

MeasureTime frame
Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -

Countries

Austria

Contacts

Public ContactSponsor and PI

Medizinische Universität Innsbruck

mui-sponsor@i-med.ac.at004351250423251

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026