NCT00958126

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,313 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CSL425	CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
BIOLOGICAL	CSL425	CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
BIOLOGICAL	Placebo	Vaccine diluent, thimerosal 0.01% (weight/volume).

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-08-13
• Last updated: 2017-11-21
• Results posted: 2012-10-03

Locations

11 sites across 1 country: United States