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
1 other identifier
interventional
1,197
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Typical duration for phase_3
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 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 14, 2017
CompletedFirst Submitted
Initial submission to the registry
April 16, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedJune 13, 2018
April 1, 2018
3.1 years
April 16, 2018
June 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
The seroconversion rates (SCRs) of susceptible subjects in each group
30 days
The geometric mean increase (GMI) of susceptible subjects in each group
30 days
The overall post-immune GMT of each group
30 days
The overall GMI of each group
30 days
The incidences of adverse events (AEs) of each group
30 days
- +1 more secondary outcomes
Study Arms (4)
Experimental Group1
EXPERIMENTALThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
Experimental Group2
EXPERIMENTALThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
Experimental Group3
EXPERIMENTALThe investigated vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at commercialized scale. Intervention: Live attenuated varicella vaccine manufactured at commercialized scale
Control Group
ACTIVE COMPARATORThe control vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd at trial-scale. Intervention: Live attenuated varicella vaccine manufactured at trial-scale
Interventions
Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shengli Xia
Henan Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2018
First Posted
June 13, 2018
Study Start
April 7, 2014
Primary Completion
May 20, 2017
Study Completion
September 14, 2017
Last Updated
June 13, 2018
Record last verified: 2018-04