Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Public ClinicalTrials.gov record NCT00914732. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Comparison of the Safety and Immunogenicity of Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid Formulation IMVAMUNE® (1x10^8 TCID50) Administered by the Subcutaneous Route and a Lower Dose Liquid Formulation IMVAMUNE® (2x10^7 TCID50) Administered by the Intradermal Route in Healthy Vaccinia-Naïve Individuals
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.
Study identification
- NCT ID
- NCT00914732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 523 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 38 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2010
- Primary completion
- Mar 31, 2011
- Completion
- Mar 31, 2011
- Last update posted
- Feb 2, 2021
2010 – 2011
United States locations
- U.S. sites
- 8
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emory Vaccine Center - The Hope Clinic | Decatur | Georgia | 30030-1705 | — |
| University of Iowa - Vaccine Research & Education Unit | Iowa City | Iowa | 52242-2600 | — |
| University of Maryland School of Medicine - Center for Vaccine Development - Baltimore | Baltimore | Maryland | 21201-1509 | — |
| Saint Louis University - Center for Vaccine Development | St Louis | Missouri | 63104-1015 | — |
| Vanderbilt University Hospital - Pediatric Clinical Research | Nashville | Tennessee | 37232-0004 | — |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | — |
| Group Health Research Institute - Seattle | Seattle | Washington | 98101-1466 | — |
| The University of Washington - Virology Research Clinic | Seattle | Washington | 98104-2433 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00914732, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00914732 live on ClinicalTrials.gov.