A/H5N1in Adult - Aventis
Public ClinicalTrials.gov record NCT00115986. 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, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to compare how the body reacts to different strengths of the new H5N1 flu vaccine. The study will also look at how antibodies are made after a subject receives the H5N1 flu vaccine. The vaccine will be given as a shot in the arm. Participants will be randomly assigned to receive 1 of 4 different dosages of the vaccine or a placebo (dummy) dose of the vaccine. Study procedures will include a physical exam, a urine pregnancy test for women, and blood samples. Participants will be asked to complete a diary to record temperatures, medications taken, and side effects from the vaccine. Volunteers will be involved with study procedures for approximately 7 months. The study will enroll about 450-470 healthy participants, ages 18-64.
Study identification
- NCT ID
- NCT00115986
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 452 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- Feb 28, 2005
- Primary completion
- Not listed
- Completion
- Jan 31, 2006
- Last update posted
- Aug 22, 2013
2005 – 2006
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Center For Vaccine Research | Torrance | California | 90502 | — |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | — |
| University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases | Rochester | New York | 14642-0001 | — |
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 NCT00115986, 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 Aug 22, 2013 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00115986 live on ClinicalTrials.gov.