Varicella
Conditions
Keywords
live attenuated varicella vaccine, safety, adult, adolescent, child
Brief summary
The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.
Detailed description
This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative 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, positive control group, or negative control group in the ratio 1:1:1.
Interventions
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
BIOLOGICALcontrol live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
BIOLOGICALdiluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
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 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteer between 1 - 49 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 infant 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; * Breast feeding, pregnant, or expected to conceive during the period of this trial; * 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 of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity: 1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count; 2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine; 3. Urine routine tests: urine protein, urine glucose, urine erythrocyte * 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 adverse events (AEs) of each group | 30 days | AEs occurred within 30 days after injection will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidences of abnormal results of lab tests | 30 days | Cases of abnormal results of laboratory tests will be collected. |
| The incidences of serious adverse events (SAEs) of each group | 30 days | SAEs occurred within 30 days after injection will be collected. |
Countries
China
Outcome results
None listed