The Safety and Immunogenicity Research of Live Attenuated... | NCT01866566

Studies
The Safety and Immunogenicity Research of Live Attenuated Varicella Vaccine After the 2 Doses Vaccination

NCT01866566

Sponsor

Beijing Center for Disease Control and Prevention

Status

Unknown status

Last Update Posted

Jun 26, 2013Estimated

Enrollment

1,800Estimated

Phase

Phase 4

Conditions

Varicella

Interventions

HBV-3
HBV-6
varicella-3
varicella-6

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

May 28, 2013

First Submission Date that Met QC Criteria

May 28, 2013

First Posted Date

May 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2013

Last Update Posted Date

Jun 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Healthy participants aged 1 to 12 years old who had never received Varicella Vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. In each age group, participants are randomly divided into experiment group and control groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HBV-3	Biological	Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month	HBV-3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of participants who have adverse reaction	The safety is evaluated by systemic and local reaction after each vaccination.	1 year

Other Outcomes

Measure	Description	Time Frame
Number of participants who catch chickenpox		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-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.

Exclusion Criteria:

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
Thyroid resection history or thyroid disease treatment in the past 12 months;
Asthma
Have participated in other clinical research;
Have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Nianmin Shi	Contact	86-010-67773550		cycdc2011@163.com
Li Li	Contact

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases