NCT01089660

A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults

Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine in healthy adults given a lower vaccine dose and in a similar group given a full dose of the vaccine. The primary objective is to describe describe the immune response of the inactivated, split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.

Detailed description

All participants will receive a single dose of study vaccine and will also be monitored for serious adverse events and adverse events of special interest occurring from Days 0 to 21 and at 6 months post-vaccination.

Conditions

• Influenza
• Swine-origin A/H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Swine A/H1N1 influenza vaccine (split virion, inactivated)	0.3 mL, Intramuscular (IM)
BIOLOGICAL	Swine A/H1N1 influenza vaccine (split virion, inactivated)	0.5 mL, Intramuscular (IM)

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-09-01
• Completion: 2010-12-01
• First posted: 2010-03-18
• Last updated: 2014-01-14

Locations

2 sites across 1 country: France