Observational Follow-up Extension Study of AFF002 & AFF004A NCT01357629

Updated 06/21/2024

Clinical Trial Details — Status: Terminated

Administrative data
NCT number	NCT01357629
Other study ID #	AFF004E
Secondary ID
Status	Terminated
Phase	N/A
First received	March 21, 2011
Last updated	December 10, 2013
Start date	July 2011
Est. completion date	November 2013

Study information
Verified date	December 2013
Source	Affiris AG
Contact	n/a
Is FDA regulated	No
Health authority	Austria: Federal Office for Safety in Health Care
Study type	Observational

Clinical Trial Summary

This study examines the long term Safety Follow-up of first patients vaccinated with AD02.

Description:

Patients who have received AD02 during AFF002 and AFF004A will be observed.

Recruitment information / eligibility
Status	Terminated
Enrollment	11
Est. completion date	November 2013
Est. primary completion date	April 2013
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	Inclusion Criteria: - participation in AFF002 and AFF004A Exclusion Criteria: - no vaccination with AD02

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country	Name	City	State
Austria	Studienzentrum der PROSENEX Ambulatoriumsbetriebs GmbH	Vienna
Austria	Univ. Klinik für Psychiatire und Psychotherapie	Wien

Sponsors *(1)*
Lead Sponsor	Collaborator
Affiris AG

Country where clinical trial is conducted

Austria,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Safety	collection and evaluation of AEs, SAEs	up to 2 years	Yes

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