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

NCT00630331 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	11404
Start date	2007-10
Completion	2008-07

Conditions

• Influenza

Interventions

• Cell culture-derived influenza vaccine
• Egg-derived influenza virus vaccine
• Placebo

Primary outcomes

• Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains — 6 Months
  The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

Countries

United States, Finland, Poland