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

Varicella Clinical Trial

Official title:

A Blind, Randomized and Controlled Clinical Trial to Evaluate the Safety of Live Attenuated Varicella Vaccines for Healthy Adults, Adolescents and Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965404
• Other study ID #: PRO-VZV-1001
• Status: Completed
• Phase: Phase 1
• First received: November 14, 2016
• Last updated: October 24, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: August 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 49 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
• control live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
• diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology

Locations

Country	Name	City	State
China	Xiangcheng County Center for Disease Control and Prevention	Xuchang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidences of adverse events (AEs) of each group	AEs occurred within 30 days after injection will be collected.	30 days
Secondary	The incidences of abnormal results of lab tests	Cases of abnormal results of laboratory tests will be collected.	30 days
Secondary	The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 30 days after injection will be collected.	30 days