Dose Ranging Study to Evaluate Immunogenicity and Safety of Adjuvanted or Non-adjuvanted Cell Culture-derived H5N1 Influenza Vaccine in Young Adults (18-40 Years Old)
Public ClinicalTrials.gov record NCT00812019. 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, Observer-blind, Multicenter, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine in Healthy Subjects 18 - 40 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.
Study identification
- NCT ID
- NCT00812019
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 753 participants
Conditions and interventions
Conditions
Interventions
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_25%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_50%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_100%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_0%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_25%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_50%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 7.5_100%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_0%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_25%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_50%MF59 Biological
- Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 15_100%MF59 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 40 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
- Oct 31, 2008
- Primary completion
- Feb 28, 2009
- Completion
- Oct 31, 2010
- Last update posted
- Aug 23, 2020
2008 – 2010
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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00812019, 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 23, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00812019 live on ClinicalTrials.gov.