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

• Register: EUCTR
• Last refreshed on: 31 August 2015
• Main ID: EUCTR2012-002867-86-DK
• Date of registration: 12/02/2013
• Prospective Registration: Yes
• Primary sponsor: Statens Serum Institut
• Public title: Prevention of serious pneumococcal infections in people with Crohn's disease
• Scientific title: 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
• Date of first enrolment: 13/02/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002867-86
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Denmark

Contacts

• Name: Bjørn Kantsø
• Affiliation: Statens Serum Institut

• Name: Bjørn Kantsø
• Affiliation: Statens Serum Institut

Key inclusion & exclusion 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:
<18 years of age, pregnant, anemia, previously pneumococcus vaccination


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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

Intervention(s)

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

Primary Outcome(s)

Main Objective: To evaluate the impact of immunosuppressive drugs on the vaccination response in patients with Crohn's disease

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 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)

Secondary Outcome(s)

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

Secondary ID(s)

BJK001

Source(s) of Monetary Support

Colitis-Crohn Foreningen

Civilingeniør Johannes E. Ormstrup og hustru Grete Ormstrups fond

Pfizer