Long-term Safety and Tolerability of AFFITOPE AD02
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD02 Applied During AFFiRiS 002
2 other identifiers
observational
23
1 country
1
Brief Summary
The purpose of this study is to evaluate the long-term tolerability and -safety of AFFITOPE AD02 applied during AFFiRiS 002
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2008
CompletedFirst Posted
Study publicly available on registry
July 8, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 27, 2010
May 1, 2010
1.4 years
July 4, 2008
May 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long-term tolerability
1 year
Secondary Outcomes (1)
Clinical and immunological efficacy (evaluated in an explorative manner only)
1 year
Study Arms (2)
2
AFFITOPE AD02 with adjuvant
1
AFFITOPE AD02 without adjuvant
Eligibility Criteria
Subjects having participated in AFFiRiS 002
You may qualify if:
- Written informed consent signed and dated by patient and caregiver
- Patients having participated in AFF002 and having received at least 1 vaccination with AFFITOPE AD02
- Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits
You may not qualify if:
- Patients having received no vaccination with AFFITOPE AD02
- History of questionable compliance to visit schedule, patients not expected to finish the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Affiris AGlead
Study Sites (1)
Ordination Schmitz
Vienna, 1010, Austria
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margot Schmitz, MD Univ. D.
Ordination Schmitz
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 4, 2008
First Posted
July 8, 2008
Study Start
November 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 27, 2010
Record last verified: 2010-05