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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: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1,359 participants
Start Date 2006-06
Est. Completion 2006-08
Phase Phase 3

What the finished NCT00333398 record still lists

NCT00333398 is an interventional study that assigns participants to a tested intervention. Its 1,359 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% higher).

The record links to 0 conditions, and to 3 interventions - of which CSL Trivalent Inactivated Influenza Vaccine - Thimerosal-free is the first listed.

NCT00333398 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00333398's enrollment target sits among peer trials

1,359 180th of 2000 higher than 1,821 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00333398, the US trial registry maintained by the National Library of Medicine. NCT00333398 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.