Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group1 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
|
| Experimental Group2 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
|
| Experimental Group3 | Experimental | The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale |
|
| Control Group | Active Comparator | The control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale. Intervention: Live attenuated varicella vaccine manufactured at trial-scale |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine manufactured at commercialized scale | Biological | Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The seroconversion rates (SCRs) of susceptible subjects in each group | Subjects whose pre-immune antibody titer < 1:4 are considered susceptible. | 30 days |
| The geometric mean increase (GMI) of susceptible subjects in each group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shengli Xia | Henan Provincial Center for Disease Control and Prevention | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vaccine manufactured at trial-scale | Biological | Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0 |
|
Increase of post-immune GMT compared with pre-immune GMT.Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.
| 30 days |
| The overall post-immune GMT of each group | The GMT of all the subjects in each group. | 30 days |
| The overall GMI of each group | The GMI of all the subjects in each group. | 30 days |
| The incidences of adverse events (AEs) of each group | AEs occurred within 30 days after injection will be collected. | 30 days |
| The incidences of serious adverse events (SAEs) of each group | SAEs occurred within 30 days after injection will be collected. | 30 days |
| D007239 | Infections |