Higher Dose Intradermal H5 Vaccine
Public ClinicalTrials.gov record NCT00439335. 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 I/II Randomized, Double-Blinded Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of Immunization With Inactivated Subvirion Influenza A/H5N1 Vaccine Administered by the Intradermal or the Intramuscular Route Among Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will compare the influenza A/H5N1 virus vaccine given by injection in the muscle versus injection in the skin in healthy adults. The study will look at the safety of the injections, how the body reacts, and what the body's immune response does when the vaccine is given in the muscle versus in the skin. The study will look at 226 healthy volunteers, ages 18-49 years old. Study procedures will include getting 2 doses of vaccine 28 days apart, physical exams, follow-up clinic visits to check the places on the body where each vaccine was given, and blood sample collections. Volunteers will complete a memory aid by writing down temperatures and health changes for 7 days after each vaccination. Volunteers will be involved in the study for up to 241 days.
Study identification
- NCT ID
- NCT00439335
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 227 participants
Conditions and interventions
Conditions
Interventions
- Inactivated Influenza A Vaccine A/H5N1 Biological
- Placebo (IM) Drug
- Placebo (ID) Drug
Biological · Drug
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
- Feb 28, 2007
- Primary completion
- Jan 31, 2008
- Completion
- Jan 31, 2008
- Last update posted
- Apr 8, 2013
2007 – 2008
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | — |
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 NCT00439335, 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 Apr 8, 2013 · Synced Sep 10, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00439335 live on ClinicalTrials.gov.