Antibodies against EBLV after immunization with Rabipur

• Conditions: healthy volunteers; MedDRA version: 14.1Level: LLTClassification code 10069589Term: Rabies immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-002096-34-NL
• Lead Sponsor: Crucell Holland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-16
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 65 year
Healthy

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 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A know or suspected allergy towards one of the components of the vaccine, i.e. chicken protein, polygeline, neomycin, chlorotetracyclin and amfotericine B.
History of serious allergic reactions
Use of medication to suppress immune response
A chronic disease that affects the immune system, systemic diseases such as SLE, ANCA associated vasculitis
Pregnancy or actual child wish (upon inquiry at the time of screening)

Study & Design

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