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NCT00333398 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,359
- Enrollment target
NCT00333398 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,359 participants.
The verdict
NCT00333398, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,359 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.
Interventions
- BIOLOGICAL CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free
- BIOLOGICAL CSL Trivalent Inactivated Influenza Vaccine with Thimerosal
- BIOLOGICAL Placebo with Thimerosal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,359 participants |
| Start Date | 2006-06 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00333398
The ClinicalTrials.gov registry entry for NCT00333398 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,359 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free is the first listed.
NCT00333398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00333398 about?
NCT00333398 is a clinical study titled "Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults". The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to ...
What is the current status of trial NCT00333398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,359 participants. The study started on 2006-06. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00333398?
The interventions under investigation include: CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free (BIOLOGICAL), CSL Trivalent Inactivated Influenza Vaccine with Thimerosal (BIOLOGICAL), Placebo with Thimerosal (BIOLOGICAL).
Who is sponsoring clinical trial NCT00333398?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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