Prospective, Randomized and Comparative Study to evaluate the efficacy of two vaccines against Hepatitis B virus in inflammatory bowel disease patients

Phase 1

• Conditions: Prophylaxis against Hepatitis B virus; MedDRA version: 14.0Level: LLTClassification code 10019743Term: Hepatitis B virus (HBV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2010-023947-14-ES
• Lead Sponsor: Hospital Universitario La Princesa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-15
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients diagnosed of IBD with negative HBV serology.

2) Men & women commited to abstinence of sexual relations or to use, al least, an effective birth control method (condom, diaphragm, IUD)
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 118
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 118

Exclusion Criteria

1- Age below 18 years old.
2- Advanced Chronic Disease or any other disease that prevent from attending controls and follow-up.
3- Allergy to any of the vaccine components.
4- Previous vaccination to the HBV.
5- Women willing to get pregnant.
6- Pregnancy or breastfeeding.
7- alcohol abuse.
8- Positive serology to HBV.
9- People with immune disorders caused by other causes than treatments administered to control IBD.
10- People with chronic antibiotic treatment.
11- Lack of consent for participating in the study.

Study & Design

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