H5N1 Vaccination With and Without AS03: Systems Biology Analysis
Public ClinicalTrials.gov record NCT01573312. 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 With and Without AS03 Adjuvant: Standard & Systems Biology Analyses
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a single center, randomized, double-blinded, controlled, Phase I, small targeted prospective study in healthy male and non-pregnant female subjects, 18 to 49 years old, inclusive, designed to determine the safety, reactogenicity, and immunogenicity of an intramuscular subvirion inactivated monovalent influenza A/H5N1 (HA of A/Indonesia/05/2005) virus vaccine manufactured by Sanofi Pasteur administered at 3.75 mcg per dose given with or without AS03 adjuvant manufactured by GSK. In the study, each subject will receive two doses administered 28 days apart. This study will use a systems biology approach to assess the human early gene and protein signatures expressed at Days 1, 3, 7, and 28 after the first vaccination. The systems data will be integrated with immunogenicity and reactogenicity data to develop a systems model of the human immune response to A/H5N1 vaccine with or without AS03 adjuvant.
Study identification
- NCT ID
- NCT01573312
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Conditions
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 23, 2012
- Primary completion
- Jan 1, 2014
- Completion
- Jan 1, 2014
- Last update posted
- Oct 20, 2019
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | 37232-2573 | — |
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 NCT01573312, 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 Oct 20, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01573312 live on ClinicalTrials.gov.