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

Varicella Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555071
• Other study ID #: PRO-VZV-3002
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2014
• Est. completion date: September 14, 2017

Study information

• Verified date: April 2018
• Source: Sinovac (Dalian) Vaccine Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1197
• Est. completion date: September 14, 2017
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• Vaccine manufactured at commercialized scale
Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
• Vaccine manufactured at trial-scale
Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac (Dalian) Vaccine Technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The seroconversion rates (SCRs) of susceptible subjects in each group	Subjects whose pre-immune antibody titer < 1:4 are considered susceptible.	30 days
Secondary	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
Secondary	The overall post-immune GMT of each group	The GMT of all the subjects in each group.	30 days
Secondary	The overall GMI of each group	The GMI of all the subjects in each group.	30 days
Secondary	The incidences of adverse events (AEs) of each group	AEs occurred within 30 days after injection will be collected.	30 days
Secondary	The incidences of serious adverse events (SAEs) of each group	SAEs occurred within 30 days after injection will be collected.	30 days