A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 2
Public ClinicalTrials.gov record NCT01596725. 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 Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Indonesia/05/05 (H5N1) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Young Adults With and Without Adjuvant 2.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the immunogenicity and safety profile of the Avian flu vaccine with and without adjuvant 2 in healthy, young adults. The study is divided down into Parts A1, A2 and B. Groups within each Part will receive two doses of the assigned test article on Study Days 0 and 21. There will be a Safety Monitoring Committee assessment following Day 7 for each part, prior to allowing vaccination of subjects in subsequent Parts of the study.
Study identification
- NCT ID
- NCT01596725
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 333 participants
Conditions and interventions
Conditions
Interventions
- Monovalent Avian Influenza VLP (H5N1) Biological
- Monovalent Avian Influenza VLP (H5N1); Adjuvant Biological
- Saline Placebo Biological
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
- Apr 30, 2012
- Primary completion
- Jul 31, 2012
- Completion
- Jul 31, 2013
- Last update posted
- Feb 5, 2014
2012 – 2013
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Miami Research Associates | Miami | Florida | 33143 | — |
| Broward Research Group | Pembroke Pines | Florida | 33026 | — |
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
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 NCT01596725, 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 5, 2014 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01596725 live on ClinicalTrials.gov.