Varicella
Conditions
Keywords
live attenuated varicella vaccine, protective effect, safety, immunogenicity, child
Brief summary
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.
Detailed description
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group or control group in the ratio 1:1.
Interventions
BIOLOGICALdiluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsors
Sinovac (Dalian) Vaccine Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer between 1 - 12 years old; * Proven legal identity; * Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the volunteer being included into this study;
Exclusion criteria
* Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection; * Axillaty temperature \> 37.0 °C; * History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc; * History of epilepsy, seizures or convulsions, or a family history of mental illness, autoimmune disease or immunodeficiency; * Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases; * Acute disease or acute stage of chronic disease within 7 days prior to study entry; * Receipt of any of the following products: 1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry; 2. Any live attenuated vaccine within 1 month prior to study entry; 3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry; * Any significant abnormity of heart, lung, skin, or pharynx; * Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of varicella of each group | ≥30 cases reported 30 days after injection | The first 30 cases of varicella occurred 30 days after injection will be collected. |
| The protection rate of the vaccine | ≥30 cases reported after 30 days of the injection | The protection rate will be calculated based on the reported cases occurred 30 days after injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate of the immunogenicity group | 30 days after injection | Seroconversion rate of the immonogenicity group 30 days after injection will be collected. |
| The incidences of adverse events (AEs) of each group | 30 days | AEs occurred within 30 days after injection will be collected. |
| The geometric mean fold increase (GMI) of the immunogenicity group | 30 days after injection | Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer. |
| The geometric mean titer (GMT) of the immunogenicity group | 30 days | Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection. |
| The incidences of serious adverse events (SAEs) of each group | 6 months | SAEs occurred within 6 months after injection will be collected. |
Countries
China
Outcome results
None listed