NCT01008137

Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults

Cell-mediated Immunity Study of H1N1 Influenza A Vaccine With Trivalent Inactivated Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H1N1 influenza A Vaccine (PANFLU.1)	H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)
BIOLOGICAL	Trivalent Inactivated Influenza Vaccine (ANFLU)	Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)

Timeline

• Start date: 2009-10-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-11-05
• Last updated: 2012-11-27

Locations

1 site across 1 country: China