NCT00952276

A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 548 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after a single injection. * To describe the safety of the candidate vaccines after a single injection.

Detailed description

Participants will receive a single injection of their randomized vaccine on Day 0.

Conditions

• Influenza
• Swine-origin A/H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant	0.5 mL, Intramuscular on Day 0
BIOLOGICAL	Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant	0.5 mL, Intramuscular on Day 0
BIOLOGICAL	Monovalent Subvirion A/H1N1 influenza vaccine	0.5 mL, Intramuscular on Day 0
BIOLOGICAL	Monovalent Subvirion A/H1N1 influenza vaccine	0.5 mL, Intramuscular on Day 0
BIOLOGICAL	Normal saline solution	0.5 mL, Intramuscular on Day 0

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2009-08-06
• Last updated: 2011-10-03
• Results posted: 2011-10-03

Locations

15 sites across 1 country: United States