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

Phase 1

• Conditions: Healthy volunteers above 25 years of age; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-000836-24-NL
• Lead Sponsor: ational Institute of Health and the Environment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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

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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 165

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).

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 clinical trial of medicinal product
• Study Design: Not specified