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

NCT02981836 | Completed Phase 3 DMC

• 1 other identifier: PRO-VZV-3001
• Study Type: interventional
• Target: 5,997
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Varicella

Keywords

live attenuated varicella vaccine; protective effect; safety; immunogenicity; child

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

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

  30 days

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

  6 months

• The seroconversion rate of the immunogenicity group

  30 days after injection

• The geometric mean titer (GMT) of the immunogenicity group

  30 days

• The geometric mean fold increase (GMI) of the immunogenicity group

  30 days after injection

Study Arms (2)

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

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 vaccine BIOLOGICAL

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

Experimental Group

diluent of lyophilized vaccine BIOLOGICAL

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

Control Group

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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:
• 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 other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;

Sponsors & Collaborators

• Sinovac (Dalian) Vaccine Technology Co., Ltd.: lead

Study Sites (2)

Xiangcheng County Center for Disease Control and Prevention

Xuchang, Henan, 461700, China

Location

Biyang County Center for Disease Control and Prevention

Zhumadian, Henan, 463700, China

Location

Related Publications (2)

• Zhang Y, Wang L, Wang Y, Zhang W, Jia N, Xie Z, Huang L, You W, Lu W, Li E, Gao F, Hu Y, Meng F, Xia S. Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years. Vaccines (Basel). 2022 Apr 22;10(5):660. doi: 10.3390/vaccines10050660.

  PMID: 35632416 DERIVED

• Hao B, Chen Z, Zeng G, Huang L, Luan C, Xie Z, Chen J, Bao M, Tian X, Xu B, Wang Y, Wu J, Xia S, Yuan L, Huang J. Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial. Clin Microbiol Infect. 2019 Aug;25(8):1026-1031. doi: 10.1016/j.cmi.2018.12.033. Epub 2019 Jan 4.

  PMID: 30616012 DERIVED

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Shengli Xia

  Henan Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 28, 2016
• First Posted: December 5, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)