NCT01684072

Brief Summary

The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
Last Updated

September 12, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

September 9, 2012

Last Update Submit

September 9, 2012

Conditions

ChickenpoxZoster

Keywords

varicella vaccinegelatin

Outcome Measures

Primary Outcomes (1)

  • To evaluate the immunogenicity of evaluated vaccine

    The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.

    8 months

Secondary Outcomes (1)

  • To evaluate the safety of live attenuated varicella vaccine

    4 months

Study Arms (2)

vaccine without gelatin

EXPERIMENTAL

use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: vaccine without gelatinBiological: vaccine with gelatin

vaccine with gelatin

ACTIVE COMPARATOR

use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

Biological: vaccine without gelatinBiological: vaccine with gelatin

Interventions

vaccine without gelatinBIOLOGICAL

use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

vaccine with gelatinvaccine without gelatin
vaccine with gelatinBIOLOGICAL

use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection

vaccine with gelatinvaccine without gelatin

Eligibility Criteria

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

You may qualify if:

  • Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
  • Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
  • Participant is aged ≥ 1 year to ≤ 12 years
  • Body temperature ≤ 37.0℃
  • Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster

You may not qualify if:

  • Known allergy to any constituent of the vaccine
  • Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Known bleeding disorder
  • Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Participation in any other interventional clinical trial
  • An acute illness with or without fever (temperature \> 37.0℃) in the latest week preceding enrollment in the trial
  • Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
  • Reported clearly the infection of the upper respiratory tract with 6 months
  • Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chaoyang District Center for Disease Control and Prevention

Beijing, Beijing Municipality, China

Location

Sanhe Center for Disease Control and Prevention

Langfang, Hebei, China

Location

Jiuyuan Center for Disease Control and Prevention

Baotou, Inner Mongolia, China

Location

MeSH Terms

Conditions

ChickenpoxHerpes Zoster

Interventions

VaccinesGelatin

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Biological ProductsComplex MixturesScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Nianmin Shi

    Beijing Chaoyang District Center for Disease Control and Prevention

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 12, 2012

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

January 1, 2012

Last Updated

September 12, 2012

Record last verified: 2012-09

Locations

CN(3)