NCT01494740

Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	split-virion, non-adjuvanted vaccine of 7.5 μg	120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 15 μg	120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
BIOLOGICAL	split-virion, non-adjuvanted vaccine of seasonal influenza	120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2011-12-19
• Last updated: 2011-12-19

Locations

1 site across 1 country: China