NCT01654809

Safety and Immunogenicity Study of Split Influenza Virus Vaccine in Different Age Groups

Evaluation of Safety and Immunogenicity Among Different Age-groups Receiving Different Split Influenza Vaccines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to observe the adverse reaction ratio and hemagglutination inhibition (HI) antibody positive rate, Geometric mean titer (GMT) of three brands split influenza virus vaccine in different population.

Detailed description

Observational Objectives: To describe the safety of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months,6th to 12th birthday and ≥ 60th birthday. To describe the immunogenicity of evaluated vaccine, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to ≤ 36 months, 6th to 12th birthday and ≥ 60rd birthday.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	evaluated vaccine	0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
BIOLOGICAL	imported compared vaccine	0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
BIOLOGICAL	domestic compared vaccine	0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-02-01
• Completion: 2011-06-01
• First posted: 2012-08-01
• Last updated: 2012-10-02

Locations

2 sites across 1 country: China