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

NCT ID: NCT03555071

Last Updated: 2018-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-07
• Study Completion Date: 2017-09-14

Brief Summary

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.

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 .

Conditions

Varicella

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Vaccine manufactured at commercialized scale

Intervention Type: BIOLOGICAL

Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0

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

Group Type: EXPERIMENTAL

Vaccine manufactured at commercialized scale

Intervention Type: BIOLOGICAL

Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0

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

Group Type: EXPERIMENTAL

Vaccine manufactured at commercialized scale

Intervention Type: BIOLOGICAL

Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0

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

Group Type: ACTIVE_COMPARATOR

Vaccine manufactured at trial-scale

Intervention Type: BIOLOGICAL

Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0

Interventions

Vaccine manufactured at commercialized scale

Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0

Intervention Type: BIOLOGICAL

Vaccine manufactured at trial-scale

Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac (Dalian) Vaccine Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shengli Xia

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial Center for Disease Control and Prevention

Other Identifiers

PRO-VZV-3002

Identifier Type: -

Identifier Source: org_study_id