The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.
The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,197
Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0
The post-immune geometric mean titer (GMT) of susceptible subjects in each group.
Subjects whose pre-immune antibody titer \< 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).
Time frame: 30 days
The overall seroconversion rates (SCRs) of each group.
Subjects whose pre-immune antibody titer\< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.
Time frame: 30 days
The seroconversion rates (SCRs) of susceptible subjects in each group
Subjects whose pre-immune antibody titer \< 1:4 are considered susceptible.
Time frame: 30 days
The geometric mean increase (GMI) of susceptible subjects in each group
Increase of post-immune GMT compared with pre-immune GMT.Subjects whose pre-immune antibody titer \< 1:4 are considered susceptible.
Time frame: 30 days
The overall post-immune GMT of each group
The GMT of all the subjects in each group.
Time frame: 30 days
The overall GMI of each group
The GMI of all the subjects in each group.
Time frame: 30 days
The incidences of adverse events (AEs) of each group
AEs occurred within 30 days after injection will be collected.
Time frame: 30 days
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The incidences of serious adverse events (SAEs) of each group
SAEs occurred within 30 days after injection will be collected.
Time frame: 30 days