H5N1 Mix and Match With AS03
Public ClinicalTrials.gov record NCT01317758. 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
A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without AS03 Adjuvant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.
Study identification
- NCT ID
- NCT01317758
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Interventions
- AS03 Adjuvant Drug
- Phosphate Buffered Saline (PBS) diluent Other
- Sanofi H5N1 Antigen Biological
Drug · Other · Biological
Eligibility (public fields only)
- Age range
- 18 Years to 49 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
- May 2011 (Type not available)
- Primary completion
- Sep 2012 (Actual)
- Completion
- Sep 2012 (Actual)
- Last update posted
- Jan 18, 2013
2011 – 2012
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland School of Medicine - Center for Vaccine Development - Baltimore | Baltimore | Maryland | 21201-1509 | — |
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
| Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | 77030-3411 | — |
| Group Health Research Institute - Seattle | Seattle | Washington | 98101-1466 | — |
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 NCT01317758, 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 Jan 18, 2013 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01317758 live on ClinicalTrials.gov.