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

October 24, 2017 updated by: Sinovac (Dalian) Vaccine Technology Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Xuchang, Henan, China, 461700
        • Xiangcheng County Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
  • Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
  • Intervention: investigational live attenuated varicella vaccine.
Biological: Investigational live attenuated varicella vaccine
The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
Active Comparator: Positive Control Group
  • Single intramuscular injection of the control vaccine (0.5 ml) on Day 0;
  • Intervention: control live attenuated varicella vaccine.
Biological: control live attenuated varicella vaccine
The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
Sham Comparator: Negative Control Group
  • Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
  • Intervention: diluent of lyophilized vaccine.
Biological: diluent of lyophilized vaccine
The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidences of adverse events (AEs) of each group
Time Frame: 30 days
AEs occurred within 30 days after injection will be collected.
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 14, 2016

First Posted (Estimate)

November 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-VZV-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Varicella

Clinical Trials on Investigational live attenuated varicella vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe