Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults
Public ClinicalTrials.gov record NCT00333398. 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 III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults Greater Than or Equal to 18 to Less Than 65 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00333398
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,359 participants
Conditions and interventions
Conditions
Interventions
- CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free Biological
- CSL Trivalent Inactivated Influenza Vaccine with Thimerosal Biological
- Placebo with Thimerosal Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years to 64 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
- May 31, 2006
- Primary completion
- Jul 31, 2006
- Completion
- Jul 31, 2006
- Last update posted
- Aug 26, 2010
2006
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305-5208 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Maryland Baltimore | Baltimore | Maryland | 21201 | — |
| Saint Louis University | St Louis | Missouri | 63131 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Duke University Medical Center | Durham | North Carolina | 27704 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | — |
| Vanderbilt University | Nashville | Tennessee | 37232-2573 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Clinical Alliance for Research & Education - Infectious Diseases | Annandale | Virginia | 22003 | — |
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 NCT00333398, 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 26, 2010 · Synced Sep 15, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00333398 live on ClinicalTrials.gov.