Pneumococcal conjugate vaccines in the elderly: The role of carrier-specific T cells

• Conditions: This study investigates humoral immune responses to pneumococcal conjugate vaccine as well as humoral and T cell responses to the diphtheria-component of the Tdap vaccine. Healthy adults over 50 years of age will receive both vaccines sequentially or simulaneously. Both vaccines are licensed for this age group; MedDRA version: 16.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1Level: LLTClassification code 10069594Term: Pneumococcal immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2014-000260-17-AT
• Lead Sponsor: niversität Innsbruck, Institut für Biomedizinische Alternsforschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-29
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

healthy adults over 50 years of age
no prior pneumococcal vaccination
last tetanus/diphtheria vaccination more than 10 years ago
signed informed consent form
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

acute illness
chronic inflammatory disease (inflammatory bowel disease, Multiple Sclerosis)
chronic infection with HBV, HCV or HIV
transplant recipients
persons who had chemotherapy in the past
persons under immunosuppressive therapy
participation in another trial 4 weeks prior to entrollment

Study & Design

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