A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981836
• Other study ID #: PRO-VZV-3001
• Status: Completed
• Phase: Phase 3
• First received: November 28, 2016
• Last updated: October 24, 2017
• Start date: August 2016
• Est. completion date: September 2017

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 protective effect, safety and immunogenicity of a live attenuated varicella vaccine in healthy children.

Description:

This study is a randomized, blind, controlled phase III clinical trial. The purpose of this study is to evaluate the protective effect, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The 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 or control group in the ratio 1:1.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5997
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer between 1 - 12 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 volunteer 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;

• 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 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.
• diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.

Locations

Country	Name	City	State
China	Xiangcheng County Center for Disease Control and Prevention	Xuchang	Henan
China	Biyang County Center for Disease Control and Prevention	Zhumadian	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 varicella of each group	The first 30 cases of varicella occurred 30 days after injection will be collected.	=30 cases reported 30 days after injection
Primary	The protection rate of the vaccine	The protection rate will be calculated based on the reported cases occurred 30 days after injection.	=30 cases reported after 30 days of the injection
Secondary	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 serious adverse events (SAEs) of each group	SAEs occurred within 6 months after injection will be collected.	6 months
Secondary	The seroconversion rate of the immunogenicity group	Seroconversion rate of the immonogenicity group 30 days after injection will be collected.	30 days after injection
Secondary	The geometric mean titer (GMT) of the immunogenicity group	Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.	30 days
Secondary	The geometric mean fold increase (GMI) of the immunogenicity group	Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.	30 days after injection