Immune responses to influenza and pneumococcal conjugate vaccines in older adults compared to middle-aged adults and adults.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 385

Inclusion Criteria

•Be 25 years or older at the time of inclusion.
•Have received a seasonal influenza vaccination in previous season (2018-2019).
•Be capacitated.
•Have signed Informed Consent

Exclusion Criteria

•Having had a previous pneumococcal vaccination (PCV or the 23-valent
pneumococcal polysaccharide vaccine (PPV23)).
•Known or suspected allergy to any of the vaccine components or having
experienced a previous severe adverse reaction to any vaccine.
•Receipt of any high-dose (>= 20 mg of prednisone daily or equivalent) daily
corticosteroids (local incl. inhaled steroids are acceptable) within 2 weeks of
study entry
•Repeated use of any high dose of corticosteroids (a dose of > 30 mg of
prednisone or equivalent per day for multiple days) in the recent past.
•Receipt of an organ- or bone marrow transplant
•Have a (functional) asplenie.
•Receipt of chemotherapy in the last 3 years.
•Receipt of blood products or immunoglobulin, within three months of study
entry.
•Known or suspected coagulation disorder that in the opinion of the
investigator would contraindicate against receiving an intramuscular injection
or undergo frequent blood sampling.
•Known anemia, measured as Hb < ( 8,5 mmol/l for men and 7,5 mmol/l for woman;
NHG standard Anemia)
•Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis
C virus (HCV) and/or hepatitis B virus (HBV).
•Known or suspected immunodeficiency or use of immunosuppressive therapy that
according to the investigator, in consultation with a medical expert,
contraindicates a Prevnar-13 vaccination.

Exclusion criteria COVID-19 vaccination study

•Treatment with COVID-19 monoclonal antibodies less that 3 months before
COVID-19 vaccination.
•Known pregnancy at the moment of COVID-19 vaccination.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are to compare vaccine-induced specific serum antibody<br /><br>levels for both the influenza quadrivalent influenza vaccine (QIV) and the<br /><br>pneumococcal PCV13 vaccine (geometric mean titters (GMTs) for influenza and<br /><br>geometric mean concentrations (GMCs) for pneumococcal vaccine* in older adults<br /><br>with those in middle-aged adults and adults one month post vaccination.</p><br>

Secondary Outcome Measures

Name	Time	Method

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