NCT00958243

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population 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 a Healthy Pediatric Population

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 6 Months – 9 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CSL's 2009 H1N1 Influenza Vaccine (CSL425)	0.5 mL intramuscular injection on Day 0 and Day 21
BIOLOGICAL	CSL's 2009 H1N1 Influenza Vaccine (CSL425)	0.25 mL intramuscular injection on Day 0 and Day 21
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-11-01
• Completion: 2010-04-01
• First posted: 2009-08-13
• Last updated: 2018-05-23
• Results posted: 2011-08-09

Locations

13 sites across 1 country: United States