NCT01040078

Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Centers for Disease Control and Prevention, China · Other Government
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Conditions

• Influenza
• Swine-origin A/H1N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	7.5ug H1N1 Influenza vaccine	0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
BIOLOGICAL	15ug H1N1 vaccine	0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
BIOLOGICAL	seasonal influenza vaccine	0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2009-12-25
• Last updated: 2009-12-30

Locations

3 sites across 1 country: China