DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Beijing Center for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Varicella

Intervention: varicella vaccine (Biological)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Beijing Center for Disease Control and Prevention

Official(s) and/or principal investigator(s):
Nianmin Shi, Principal Investigator, Affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention

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.

Clinical Details

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

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

Primary outcome: Incidence of varicella after 2 dose vaccination

Secondary outcome: Adverse event rate of varicella vaccine after 2 dose injection

Detailed 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.

Eligibility

Minimum age: 4 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Beijing Chaoyang District Centers for Disease Control and Prevention, Beijing, China
Additional Information

Starting date: April 2013
Last updated: May 27, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017