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Prevention of serious pneumococcal infections in people with Crohn's disease

Pneumococcal vaccination of Crohn patients - A randomized, non-blinded phase 4 clinical trial with the purpose of investigating the immune response against two different pneumococcal vaccines in patients with Crohn's disease - PneuVac

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002867-86-DK
Enrollment
Unknown
Registered
2013-02-12
Start date
2013-02-13
Completion date
Unknown
Last updated
2015-08-31

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

Conditions

Crohn's Disease MedDRA version: 15.1 Level: LLT Classification code 10069594 Term: Pneumococcal immunization System Organ Class: 100000004865

Interventions

Trade Name: Pnemovax Product Name: Pneumovax Pharmaceutical Form: Solution for injection/infusion Trade Name: Prevenar 13 Product Name: Prevenar 13 Pharmaceutical Form: Solution for injection

Sponsors

Statens Serum Institut
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Crohn's disease, receive immunosuppressive treatment or no treatment 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: <18 years of age, pregnant, anemia, previously pneumococcus vaccination

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease ;Secondary Objective: To evaluate the specific antibody production of two different pneumococcal vaccines (mentioned below) in patients with Crohn's disease A) pneumococcal polysaccharide vaccine (23GPS) B) pneumococcal conjugate vaccine (PCV13) ;Primary end point(s): Significant difference of antibody levels between pre-vaccnation sample and post-vaccination sample, independent of treatment for CD.;Timepoint(s) of evaluation of this end point: 4 weeks and one year past vaccination—

Secondary

MeasureTime frame
Secondary end point(s): Significant difference of antibody levels between pre-vaccnation sample and post-vaccination sample, as function off CD treatment..;Timepoint(s) of evaluation of this end point: 4 weeks and one year past vaccination—

Countries

Denmark

Contacts

Public ContactBjørn Kantsø

Statens Serum Institut

bjk@ssi.dk+4532683688

Outcome results

None listed

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