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NCT00812019 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Seqirus.
- Completed
- Registry status
- Phase 1
- Development phase
- 753
- Enrollment target
NCT00812019 is a Phase 1 study that has completed, run by Seqirus. The registered enrollment target is 753 participants.
The verdict
NCT00812019, a Phase 1 study, has completed, sponsored by Seqirus.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 753 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 753 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00812019
The ClinicalTrials.gov registry entry for NCT00812019 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 753 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cell Culture-Derived H5N1 Subunit Influenza Vaccine, 3.75_0%MF59 is the first listed.
NCT00812019 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00812019 about?
NCT00812019 is a clinical study titled "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)". 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...
What is the current status of trial NCT00812019?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 753 participants. The study started on 2008-11. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00812019?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT00812019?
This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.
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