NCT01758185

Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

Phase 4 Safety and Immunogenicity Study of Aleph Inactivated Split Influenza Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,308 (actual)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.

Detailed description

A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	recombinant hepatitis b vaccine	0.5ml intramuscular
BIOLOGICAL	Aleph influenza vaccine	0.5ml intramuscular

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-11-01
• Completion: 2012-12-01
• First posted: 2013-01-01
• Last updated: 2013-03-28

Locations

2 sites across 1 country: China