NCT01336166

The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 15 μg	120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 30 μg	120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 45 μg	120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
BIOLOGICAL	Placebo control	120 adults were assigned to receive 1 dose of placebo.

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-04-15
• Last updated: 2018-09-11

Locations

1 site across 1 country: China