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

NCT03555071 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1197

Last updated 2018-06-13

No results posted yet for this study

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.

Conditions

  • Varicella

Interventions

BIOLOGICAL

Vaccine manufactured at commercialized scale

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

BIOLOGICAL

Vaccine manufactured at trial-scale

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

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Shengli Xia · Henan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-07
Primary Completion
2017-05-20
Completion
2017-09-14

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555071 on ClinicalTrials.gov