CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 11,404 enrolled
Drug / intervention
Cell culture-derived influenza vaccine +2 morebiological
Likely dose
Cell culture-derived influenza vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00630331
NCT00630331Phase 3Completed

A Phase III, Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Assess Clinical Efficacy of a Cell-Derived Subunit Influenza Vaccine and an Egg-Derived Subunit Influenza Vaccine in the 2007-2008 Influenza Season in Healthy Adult Subjects

Novartis Vaccines·interventional·Posted Mar 7, 2008·Updated May 24, 2024

In Brief

A Phase 3 clinical trial evaluating Cell culture-derived influenza vaccine, Egg-derived influenza virus vaccine, and 1 other intervention for Influenza. Completed, enrolled 11,404 participants across 56 sites in 3 countries.

Detailed Summary

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesFinland, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2008
Enrollment StartOct 1, 2007
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.3 years ago

Interventions

Cell culture-derived influenza vaccinebiological

One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.

Egg-derived influenza virus vaccinebiological

One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.

Placebobiological

One dose (0.5 mL) of phosphate buffered solution.