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NCT00264576 · ClinicalTrials.gov registry record · Phase 2

Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults

A Phase 2 study, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 2
Development phase
613
Enrollment target

NCT00264576: Completed Phase 2 study, sponsored by Novartis Vaccines.

NCT00264576 is a Phase 2 study that has completed, run by Novartis Vaccines. The registered enrollment target is 613 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (361% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00264576, a Phase 2 study, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 2
Development phase
613 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 \< 50 years.

Primary Outcome

Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.

Interventions

  • BIOLOGICAL Influenza Virus Vaccine

Trial Details

FieldValue
Enrollment Target 613 participants
Start Date 2005-10
Est. Completion 2006-05
Phase Phase 2
Novartis Vaccines

32 total trials

What the finished NCT00264576 record still lists

NCT00264576 is an interventional study that assigns participants to a tested intervention. The registered 613 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (361% higher).

The record links to 0 conditions, and to 1 intervention - of which Influenza Virus Vaccine is the first listed.

NCT00264576 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00264576 about?

NCT00264576 is a clinical study titled "Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults". The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 \< 50 years.

What is the current status of trial NCT00264576?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 613 participants. The study started on 2005-10. Estimated completion is 2006-05.

What interventions are being tested in trial NCT00264576?

The interventions under investigation include: Influenza Virus Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00264576?

This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00264576's enrollment target sits among peer trials

613 53rd of 2000 higher than 1,948 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00264576, the US trial registry maintained by the National Library of Medicine. NCT00264576 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.