A Phase 3 Lot-consistency Clinical Trial of Live Attenuated Varicella Vaccine

A Double-blind, Randomized, Bridging Clinical Trial to Evaluate the Consistency, Immunogenicity and Safety of Live Attenuated Varicella Vaccines for Children

The purpose of this study is to evaluate consistency, immunogenicity and safety of live attenuated varicella vaccines manufactured at commercialized scale in aged 1-3 years children.

Study Overview

• Status: Completed
• Conditions: Varicella
• Intervention / Treatment: Biological: Vaccine manufactured at commercialized scale; Biological: Vaccine manufactured at trial-scale

Detailed Description

The study is a single-center, double-blind, randomized, bridging clinical trial. The purpose of this study is to evaluate the consistency between each two lots of live attenuated varicella vaccines, to evaluate the non-inferiority of the immunogenicity of live attenuated varicella vaccines manufactured at commercialized scale compared to trial-scale, and to evaluate the safety of live attenuated varicella vaccines. 1197 healthy Chinese children aged 1 to 3 years old were randomly assigned into four groups in the ratio 2:2:2:1. Children in the first three groups were administered with one dose of live attenuated varicella vaccines manufactured at commercialized scale, and children in the last group were administered with one dose of live attenuated varicella vaccines manufactured at trial-scale .

• Study Type: Interventional
• Enrollment (Actual): 1197
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteer between 1-3 years old;
• legal identity;
• Guardian(s) of the volunteer should be capable of understanding the written - consent form, and such form should be signed before the children being included into this study.

Exclusion Criteria:

• Prior vaccination with varicella vaccine or with history of varicella infection;
• Axillaty temperature > 37.0 °C before vaccination;
• 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;
• Epilepsy (except febrile seizures), history of seizures or convulsions, 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 blood product, immunosuppressant, hormone, other investigational medicine(s) within 30 days prior to study entry;
• Receipt of any live attenuated vaccine within 1 month prior to study entry, or receipt of any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
• Any significant abnormity of heart, lung, liver, spleen, lymph nodes, or pharynx;
• Based on the judgment of investigator(s), there was any condition indicating that the subject should be excluded.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group1; The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale	Biological: Vaccine manufactured at commercialized scale; Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Experimental: Experimental Group2; The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale	Biological: Vaccine manufactured at commercialized scale; Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Experimental: Experimental Group3; The investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale	Biological: Vaccine manufactured at commercialized scale; Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Active Comparator: Control Group; The control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale. Intervention: Live attenuated varicella vaccine manufactured at trial-scale	Biological: Vaccine manufactured at trial-scale; Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The post-immune geometric mean titer (GMT) of susceptible subjects in each group.	Subjects whose pre-immune antibody titer < 1:4 are considered susceptible. The GMT were measured using the method of Fluorescent Antibody to Membrane Antigen (FAMA).	30 days
The overall seroconversion rates (SCRs) of each group.	Subjects whose pre-immune antibody titer< 1:4 and post-immune antibody titer≥ 1:4, or those whose pre-immune antibody titer≥1:4 and the increase of post-immune antibody titer≥4 folds are considered seroconverted.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The seroconversion rates (SCRs) of susceptible subjects in each group	Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.	30 days
The geometric mean increase (GMI) of susceptible subjects in each group	Increase of post-immune GMT compared with pre-immune GMT.Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.	30 days
The overall post-immune GMT of each group	The GMT of all the subjects in each group.	30 days
The overall GMI of each group	The GMI of all the subjects in each group.	30 days
The incidences of adverse events (AEs) of each group	AEs occurred within 30 days after injection will be collected.	30 days
The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 30 days after injection will be collected.	30 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2014
• Primary Completion (Actual): May 20, 2017
• Study Completion (Actual): September 14, 2017

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 13, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: safety; children; live attenuated varicella vaccine; consistency; immunogenicity
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-VZV-3002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No