NCT00845429

Immunogenicity of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine in Healthy Adult Subjects

Immunogenicity of Two Dosages of a Split, Cell-Based, Inactivated, Trivalent Influenza Vaccine Administered in Healthy Adult Subjects Aged 18 to 49 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 729 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Primary Objective: To describe the immune response to a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects. Secondary Objective: To describe the safety following a single administration of 2 formulations of the investigational cell-based influenza vaccines in healthy adult subjects.

Detailed description

This is a multi-center study in healthy adult subjects. All subjects will receive a single dose of one of the influenza vaccine formulations and will provide blood samples for immunogenicity assessment.

Conditions

• Influenza
• Orthomyxoviruses
• Myxovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine - cell based (2007-2008 Formulation)	0.5 mL, Intramuscular
BIOLOGICAL	Influenza virus vaccine - cell-based (2007-2008 Formulation)	1.0 mL, Intramuscular
BIOLOGICAL	Influenza virus vaccine (2007-2008 Formulation)	0.5 mL, Intramuscular

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-08-01
• Completion: 2008-11-01
• First posted: 2009-02-18
• Last updated: 2012-12-19
• Results posted: 2012-12-17

Locations

15 sites across 1 country: United States