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

Phase 1

Completed

• Conditions: Varicella
• Interventions: Biological: control live attenuated varicella vaccine; Biological: diluent of lyophilized vaccine; Biological: Investigational live attenuated varicella vaccine

• Registration Number: NCT02965404
• Lead Sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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 Timeline

• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-08
• Status Verified: 2016-11
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive Control Group	control live attenuated varicella vaccine	* Single intramuscular injection of the control vaccine (0.5 ml) on Day 0; * Intervention: control live attenuated varicella vaccine.
Negative Control Group	diluent of lyophilized vaccine	* Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0; * Intervention: diluent of lyophilized vaccine.
Experimental Group	Investigational live attenuated varicella vaccine	* Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0; * Intervention: investigational live attenuated varicella vaccine.

Primary Outcome Measures

Name	Time	Method
The incidences of adverse events (AEs) of each group	30 days	AEs occurred within 30 days after injection will be collected.

Secondary Outcome Measures

Name	Time	Method
The incidences of serious adverse events (SAEs) of each group	30 days	SAEs occurred within 30 days after injection will be collected.
The incidences of abnormal results of lab tests	30 days	Cases of abnormal results of laboratory tests will be collected.

Trial Locations

Locations (1)

Xiangcheng County Center for Disease Control and Prevention; 🇨🇳 Xuchang, Henan, China