A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- The incidences of adverse events (AEs) of each group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Year to 49 Years (Child, Adult)
- Sex
- All
- Accepts 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:
- •Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
- •Any live attenuated vaccine within 1 month prior to study entry;
- •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:
- •Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
- •Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
- •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;
Arms & Interventions
Experimental Group
- Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
- Intervention: investigational live attenuated varicella vaccine.
Intervention: Investigational live attenuated varicella vaccine (Biological)
Positive Control Group
- Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
- Intervention: control live attenuated varicella vaccine.
Intervention: control live attenuated varicella vaccine (Biological)
Negative Control Group
- Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
- Intervention: diluent of lyophilized vaccine.
Intervention: diluent of lyophilized vaccine (Biological)
Outcomes
Primary Outcomes
The incidences of adverse events (AEs) of each group
Time Frame: 30 days
AEs occurred within 30 days after injection will be collected.
Secondary Outcomes
- The incidences of serious adverse events (SAEs) of each group(30 days)
- The incidences of abnormal results of lab tests(30 days)