NCT00956111

A Clinical Trial With Influenza A/H1N1 Vaccines

A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,614 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose	100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
BIOLOGICAL	split-virion, adjuvanted H1N1 vaccine of 15 μg per dose	100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose	100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
BIOLOGICAL	split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose	100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
BIOLOGICAL	whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose	100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart.
BIOLOGICAL	whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose	100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine
BIOLOGICAL	placebo control	100 adults were assigned to receive 2 doses of placebo 21 days apart.

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-09-01
• Completion: 2009-10-01
• First posted: 2009-08-11
• Last updated: 2021-07-29

Locations

1 site across 1 country: China