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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000260-17-AT

Enrollment

150

Registered

2014-01-29

Start date

2014-03-18

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 16.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 16.1 Level: LLT C

Interventions

Trade Name: Prevenar-13 Product Name: Prevenar-13 Pharmaceutical Form: Solution for injection INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (13-VALENT, ADSORBED) CONJUGATED TO CRM

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Does vaccination against diphtheria improve antibody responses to conjugated pneumococcal vaccine?;Secondary Objective: Does the level humoral and/or T cell responses to diphtheria-toxoid influence the antibody responses to conjugated pneumococcal vaccine? Is the effect on antibody responses to conjugated pneumococcal vaccine dependent on the timing of diphtheria vaccination (prior to or concomitant with pneumococcal vaccination)?;Primary end point(s): quantification of vaccine-induced immune response, 6 weeks after the last vaccination;Timepoint(s) of evaluation of this end point: 6 weeks after the last vaccination	—

Measure

Time frame

Main Objective: Does vaccination against diphtheria improve antibody responses to conjugated pneumococcal vaccine?;Secondary Objective: Does the level humoral and/or T cell responses to diphtheria-toxoid influence the antibody responses to conjugated pneumococcal vaccine? Is the effect on antibody responses to conjugated pneumococcal vaccine dependent on the timing of diphtheria vaccination (prior to or concomitant with pneumococcal vaccination)?;Primary end point(s): quantification of vaccine-induced immune response, 6 weeks after the last vaccination;Timepoint(s) of evaluation of this end point: 6 weeks after the last vaccination

—

Secondary

Measure	Time frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Austria

Contacts

Public ContactBeatrix Grubeck-Loebenstein

Innsbruck University, Institute for Biomedical Aging Research

beatrix.grubeck@uibk.ac.at+4351250750810

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 4, 2026