Analysis and characterization of the immune response after influenza, SARS-CoV-2 and pneumococcal vaccinations (IMMUNE Study)
- Conditions
- Analysis and characterization of the immune response after influenza, SARS-CoV-2 and pneumococcal vaccinations (IMMUNE Study)Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2021-002789-42-AT
- Lead Sponsor
- Medizinische Universität Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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 Outcome Measures
Name Time Method Secondary end point(s): -;Timepoint(s) of evaluation of this end point: -