Inactivated Influenza A/H5N1 Vaccine in the Elderly
Public ClinicalTrials.gov record NCT00230750. 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 Elderly 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 a new H5N1 flu vaccine. Researchers will also look at how antibodies are made after subjects receive the H5N1 flu vaccine. Participants will include at least 240 healthy males and females, aged 65 and older. The vaccine is given as an injection or shot in the arm. Subjects will receive 3 doses of vaccine at Day 0, Month 1 and Month 6. There are 2 different doses of the new H5N1 vaccine that will be given in this study. There is also a chance that a subject may receive a placebo (dummy) injection of saltwater instead of the flu vaccine. Study procedures will include physical exams and blood sample collections. Additionally, participants will complete a memory aid card to document daily temperatures and any symptoms experienced for a week after receiving vaccine. The length of participation in this study will be approximately 14 months.
Study identification
- NCT ID
- NCT00230750
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 261 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 65 Years and older
- 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
- Sep 30, 2005
- Primary completion
- Dec 31, 2006
- Completion
- Dec 31, 2006
- Last update posted
- Aug 22, 2013
2005 – 2007
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Center For Vaccine Research | Torrance | California | 90502 | — |
| University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases | Rochester | New York | 14642-0001 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University | 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 NCT00230750, 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 14, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00230750 live on ClinicalTrials.gov.