NCT00952419

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 474 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 9 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Conditions

• Influenza
• Swine-origin A/H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Subvirion A/H1N1 Influenza vaccine	0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
BIOLOGICAL	Monovalent Subvirion A/H1N1 Influenza vaccine	0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
BIOLOGICAL	Normal saline solution (placebo)	0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-08-06
• Last updated: 2016-04-14
• Results posted: 2011-07-11

Locations

20 sites across 1 country: United States