Comparing the effectivity of two different pneumococcal vaccines against severe pneumococcal diseases in adult kidney and liver transplant patients

Immunogenicity of repeated dose 13-valent pneumococcal conjugate vaccine compared to the existing recommended protocol of pneumococcal polysaccharide vaccine in adult kidney and liver transplant patients - SOT13

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002657-30-FI

Enrollment

150

Registered

2012-08-17

Start date

2012-09-12

Completion date

Unknown

Last updated

2025-01-07

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

Conditions

Immunogenicity of pneumococcal vaccines in liver and kidney transplant patients

Interventions

Trade Name: Prevenar 13 Pharmaceutical Form: Solution for injection INN or Proposed INN: PNEUMOCOCCAL CONJUGATE VACCINE Other descriptive name: PNEUMOCOCCAL CONJUGATE VACCINE Trade Name: Pneumovax Pr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive adult (>18 years) liver and kidney transplant patients are enrolled as they enter the transplant waiting list 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 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Age< 18 years Previous Pneumococcal vaccination < 3 years ago Febrile illness at the time of vaccination Any sign of graft failure or rejection at the time of vaccination Splenectomy Pregnancy Critically ill patient due to any cause, including terminal uncompensated liver disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To show the non-inferiority of Prevenar 13 compared to pneumovax;Secondary Objective: To show the safety of Prevenar 13 in these patient groups. To show possible superiority of the Prevenar 13 compared to Pneumovax and to see if an additive dose of Prevenar13 brings better immunogenicity;Primary end point(s): To detect any difference in immunogenicity (valued as the concenration of sertoype spcific IgG antibodies and their opsonophagocytic activity) between the PCV13 and PPV23 groups before and after the initialvaccination and 7 months after the transplantation ( 1 month after the second PCV vaccination);Timepoint(s) of evaluation of this end point: Before and after the first vaccination (prevener or Pneumovax) and before and after the second Prevenar13 vaccination which is administerated at 6 months posttransplant	—

Measure

Time frame

Main Objective: To show the non-inferiority of Prevenar 13 compared to pneumovax;Secondary Objective: To show the safety of Prevenar 13 in these patient groups. To show possible superiority of the Prevenar 13 compared to Pneumovax and to see if an additive dose of Prevenar13 brings better immunogenicity;Primary end point(s): To detect any difference in immunogenicity (valued as the concenration of sertoype spcific IgG antibodies and their opsonophagocytic activity) between the PCV13 and PPV23 groups before and after the initialvaccination and 7 months after the transplantation ( 1 month after the second PCV vaccination);Timepoint(s) of evaluation of this end point: Before and after the first vaccination (prevener or Pneumovax) and before and after the second Prevenar13 vaccination which is administerated at 6 months posttransplant

—

Secondary

Measure	Time frame
Secondary end point(s): To detect the safety aspects of repeated PCV13 doses in these patient groups;Timepoint(s) of evaluation of this end point: Patients are followed and monitored for AEs and SAEs throughout the study but especially 8 weeks time after each vaccination	—

Countries

Finland

Outcome results

None listed

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