A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

Sinovac

Status and phase: Completed; Phase 1

Conditions: Varicella

Treatments: Biological: control live attenuated varicella vaccine; Biological: Investigational live attenuated varicella vaccine; Biological: diluent of lyophilized vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02965404

PRO-VZV-1001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 1 to 49 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 3 patient groups

Experimental Group

Experimental group

Description:

* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated varicella vaccine.

Treatment:

Biological: Investigational live attenuated varicella vaccine

Positive Control Group

Active Comparator group

Description:

* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated varicella vaccine.

Treatment:

Biological: control live attenuated varicella vaccine

Negative Control Group

Sham Comparator group

Description:

* Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine.

Treatment:

Biological: diluent of lyophilized vaccine