NCT01866566

Brief Summary

Through evaluating the immunogenicity and safety for Varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

June 26, 2013

Status Verified

May 1, 2013

Enrollment Period

7 months

First QC Date

May 28, 2013

Last Update Submit

June 25, 2013

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

  • Antibody titer after 2 doses lived attenuated varicella vaccination

    Serums are collected from all participants before and 42 days after the first vaccination, and also 42 days after the second vaccination. The antibody titer to Varicella was detected through FAMA test.

    1 year

Secondary Outcomes (1)

  • Number of participants who have adverse reaction

    1 year

Other Outcomes (1)

  • Number of participants who catch chickenpox

    3 years

Study Arms (4)

HBV-3

PLACEBO COMPARATOR

one dose HBV

Biological: HBV-3

HBV-6

PLACEBO COMPARATOR

one dose HBV

Biological: HBV-6

varicella-3

EXPERIMENTAL

2 doses varicella vaccine either BCHT or Kengen and 3 month of the interval time

Biological: varicella-3

varicella-6

EXPERIMENTAL

2 doses varicella vaccine either BCHT or Kengen and 6 month of the interval time

Biological: varicella-6

Interventions

HBV-3BIOLOGICAL

Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month

HBV-3
HBV-6BIOLOGICAL

Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month

HBV-6
varicella-3BIOLOGICAL

Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month

varicella-3
varicella-6BIOLOGICAL

Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month

varicella-6

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participants from Shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor.

You may not qualify if:

  • Having a fever (axillary temperature\>37.0℃) before enrollment;
  • Having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions;
  • Antibiotics allergy;
  • Having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder;
  • Having immunodeficiency or under immunosuppression therapy, radiation therapy;
  • Having respiratory diseases, acute infection, chronic disease and HIV infection;
  • Having systemic skin rash, skin tinea, herpes;
  • Chronic liver and kidney disease;
  • Heart disease, and severe hypertension;
  • Have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment;
  • Have received other live attenuated vaccine vaccination in 30 days before enrollment;
  • Had been infected with Varicella virus and displayed symptom;
  • Have received one or two dose of Varicella vaccine before enrollment;
  • Congenital malformations, growth disorders such as Down's syndrome, diabetes, sickle cell anemia and nervous disorders
  • Guillain-barre syndrome
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanxi Centers for Disease Control and Prevention

Yuncheng, Shanxi, China

RECRUITING

MeSH Terms

Conditions

Chickenpox

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Nianmin Shi

    Beijing Chaoyang District Centers for Disease Control and Prevention

    STUDY CHAIR

Central Study Contacts

Nianmin Shi

CONTACT

86-010-67773550cycdc2011@163.com

Li Li

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2016

Last Updated

June 26, 2013

Record last verified: 2013-05

Locations

CN(1)