Staggered vaccination compared to simultaneous vaccination with pneumococcal conjugate vaccine (PCV13) and Pneumokokkenpolysaccharidvakzine (PPV23) in unvaccinated older adults: Immunological memory and antibody levels

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Immune system processes [G12]; previously unvaccinated older healthy adults; MedDRA version: 21.1Level: PTClassification code 10069578Term: Pneumococcal immunisationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2014-004013-85-DE
• Lead Sponsor: Friedrich Schiller University Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-19
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• male and female adults aged 60 years
• written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132

Exclusion Criteria

•Hypersensitivity to any component of the vaccine
•prior pneumococcal vaccination
•Pneumonia in the last 2 months
•active infection
•autoimmune disorder (e.g. lupus erythematodes,Wegener's granulomatosis)
•ongoing or planned immunosuppressive therapy (with corticosteroid therapy from a prednisolone equivalent dose = 5 mg /d)
•active tumor disease
•drug or alcohol abuse, or estimate other diseases that do not allow the person concerned, the nature and scope and possible consequences of the trial, incl. non-cooperation
•expectancy of life < 2 years
•receive blood products in the last six month
•all states which represent a contraindication to intramuscular administration of vaccines
•blood coagulation disorders (e.g. haemophilia, use of oral anticoagulation ,current thrombolytic therapy )
•incineration, injury or infection at the planned injection position
•Plegie or paresis of the extremities at the planned injection position
•states of shock
•parallel participation in another clinical trial with intervention

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified