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NCT00316602 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
A Phase 2 study, sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 2
- Development phase
- 632
- Enrollment target
NCT00316602: Completed Phase 2 study, sponsored by Bavarian Nordic.
NCT00316602 is a Phase 2 study that has completed, run by Bavarian Nordic. The registered enrollment target is 632 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (375% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316602, a Phase 2 study, has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 632 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
Primary Outcome
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Interventions
- BIOLOGICAL IMVAMUNE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 632 participants |
| Start Date | 2006-07 |
| Est. Completion | 2010-04 |
| Phase | Phase 2 |
What the finished NCT00316602 record still lists
NCT00316602 is an interventional study that assigns participants to a tested intervention. The registered 632 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (375% higher).
The record links to 0 conditions, and to 1 intervention - of which IMVAMUNE is the first listed.
NCT00316602 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316602 about?
NCT00316602 is a clinical study titled "A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis". The purpose of this study is to compare the immunogenicity and safety of an investigational smallpox vaccine in subjects with atopic dermatitis to healthy volunteers.
What is the current status of trial NCT00316602?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 632 participants. The study started on 2006-07. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00316602?
The interventions under investigation include: IMVAMUNE (BIOLOGICAL).
Who is sponsoring clinical trial NCT00316602?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316602's enrollment target sits among peer trials
632 51st of 2000 higher than 1,950 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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