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NCT00879762 · ClinicalTrials.gov registry record · Phase 2
High Dose IMVAMUNE® in Vaccinia-Naive Individuals
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 91
- Enrollment target
NCT00879762: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00879762 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 91 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00879762, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 91 participants
- Enrollment target
Study Summary
The purpose of this research is to compare the ability of a new investigational smallpox vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if given as one single, higher dose compared with two lower doses given one month apart. Another purpose of the study is to see how quickly someone might be protected against smallpox. Volunteers will be vaccinia-naïve adults age 18 and older (born after 1971) divided into 2 groups. Volunteers in Group A will receive a high dose of vaccine given in 2 shots on day 0 followed by a placebo (inactive substance) shot on day 28. Group B will receive the standard dose of vaccine and placebo given in 2 shots on day 0 followed by a standard dose shot on Day 28. Study participation will include 10 planned study visits over approximately 7 months.
Primary Outcome
Seroconversion is defined as a titer \>= 50 or as a 2-fold or greater increase in titer from baseline if pre-vaccination titer was \>= 50. Participants who did not seroconvert during the study were analyzed as right censored at the last sample collection date. Samples collected after the second vaccination were also analyzed as right censored.
Interventions
- OTHER Placebo
- BIOLOGICAL MVA Smallpox Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 91 participants |
| Start Date | 2009-05-29 |
| Est. Completion | 2011-03-09 |
| Phase | Phase 2 |
What the finished NCT00879762 record still lists
NCT00879762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 91 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00879762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00879762 about?
NCT00879762 is a clinical study titled "High Dose IMVAMUNE® in Vaccinia-Naive Individuals". The purpose of this research is to compare the ability of a new investigational smallpox vaccine called IMVAMUNE® to produce a strong immune response against smallpox disease if given as one single, higher dose compared with two lower doses given one month apart. Another purpose of the study is to s...
What is the current status of trial NCT00879762?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 91 participants. The study started on 2009-05-29. Estimated completion is 2011-03-09.
What interventions are being tested in trial NCT00879762?
The interventions under investigation include: Placebo (OTHER), MVA Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00879762?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00879762's enrollment target sits among peer trials
91 771st of 2000 higher than 1,229 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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