NCT00630331

Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11,404 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell culture-derived influenza vaccine	One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
BIOLOGICAL	Egg-derived influenza virus vaccine	One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
BIOLOGICAL	Placebo	One dose (0.5 mL) of phosphate buffered solution.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-03-07
• Last updated: 2024-05-24
• Results posted: 2013-01-16

Locations

56 sites across 3 countries: United States, Finland, Poland