The Safety, Immunogenicity and Immune Effect Research of the Varicella Vaccine After the 2nd Dose Vaccination

Varicella Clinical Trial

Official title:

Phase 4 Study of the Varicella Vaccine After the 2nd Dose Vaccination

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01830283
• Other study ID #: BJCDPC-8
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 3, 2013
• Last updated: May 27, 2013
• Start date: April 2013
• Est. completion date: April 2018

Study information

• Verified date: April 2013
• Source: Beijing Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To investigate the safety, immunogenicity and immune effect of the Varicella vaccine after the 2nd dose vaccination in Chao yang district, Bei jing, since the 2nd varicella vaccination was promoted by Beijing Center for Disease Control and Prevention in November, 2012.

Description:

"Breakthrough" varicella cases and varicella cases were monitored to evaluate the protective effective in a large population.

Make the basic evaluation of safety for the two dose of varicella vaccination

Monitoring the Varicella virus origin and virus types from illness cases in Chao yang district

Make the evaluation of healthy costs reduce for the varicella emergency vaccination after large number of varicella cases occurred.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50000
• Est. completion date: April 2018
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Participants were between 4-12 years old

• Participants were in good healthy determined through medical history, 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 and mental 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 not received other vaccination in 7 days before enrollment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• varicella vaccine
The providers would get varicella vaccine

Locations

Country	Name	City	State
China	Beijing Chaoyang District Centers for Disease Control and Prevention	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibody titre of varicella vaccine after 2 dose injection	Antibody titre of varicella vaccine after 2 dose injection	6 monthes	No
Primary	Incidence of varicella after 2 dose vaccination	Detection the Varicella virus origin and virus types from illness cases in Chao yang district	5 years	Yes
Secondary	Adverse event rate of varicella vaccine after 2 dose injection	Adverse event rate of varicella vaccine after 2 dose injection	5 years	Yes