NCT01684072

Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin

Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (actual)
• Sponsor: Beijing Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Detailed description

Observational Objectives: To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday. To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.

Conditions

• Chickenpox
• Zoster

Interventions

Type	Name	Description
BIOLOGICAL	vaccine without gelatin	use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
BIOLOGICAL	vaccine with gelatin	use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-09-01
• Completion: 2012-01-01
• First posted: 2012-09-12
• Last updated: 2012-09-12

Locations

3 sites across 1 country: China