NCT02965404

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
Last Updated

October 26, 2017

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

November 14, 2016

Last Update Submit

October 24, 2017

Conditions

Varicella

Keywords

live attenuated varicella vaccinesafetyadultadolescentchild

Outcome Measures

Primary Outcomes (1)

  • The incidences of adverse events (AEs) of each group

    AEs occurred within 30 days after injection will be collected.

    30 days

Secondary Outcomes (2)

  • The incidences of abnormal results of lab tests

    30 days

  • The incidences of serious adverse events (SAEs) of each group

    30 days

Study Arms (3)

Experimental Group

EXPERIMENTAL

* 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

Positive Control Group

ACTIVE COMPARATOR

* 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

Negative Control Group

SHAM COMPARATOR

* 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

Interventions

Investigational live attenuated varicella vaccineBIOLOGICAL

The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.

Experimental Group
control live attenuated varicella vaccineBIOLOGICAL

The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)

Positive Control Group
diluent of lyophilized vaccineBIOLOGICAL

The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology

Negative Control Group

Eligibility Criteria

Age1 Year - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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:
  • Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  • Any live attenuated vaccine within 1 month prior to study entry;
  • 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:
  • Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, 461700, China

Location

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Shengli Xia

    Henan Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 16, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

August 1, 2016

Last Updated

October 26, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)