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

NCT01830283 | Unknown Phase 4

• 1 other identifier: BJCDPC-8
• Study Type: interventional
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Varicella

Outcome Measures

Primary Outcomes (1)

• Incidence of varicella after 2 dose vaccination

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

  5 years

Secondary Outcomes (1)

• Adverse event rate of varicella vaccine after 2 dose injection

  5 years

Other Outcomes (1)

• Antibody titre of varicella vaccine after 2 dose injection

  6 monthes

Study Arms (2)

1 dose varicella vaccine

ACTIVE COMPARATOR

The providers would get the 2nd dose since they had one dose varicella vaccine

Biological: varicella vaccine

2 dose varicella vaccine

EXPERIMENTAL

The provider never get the varicella vaccine

Biological: varicella vaccine

Interventions

varicella vaccine BIOLOGICAL

The providers would get varicella vaccine

1 dose varicella vaccine; 2 dose varicella vaccine

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants were between 4-12 years old
• Participants were in good healthy determined through medical history, 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 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

Sponsors & Collaborators

• Beijing Center for Disease Control and Prevention: lead

Study Sites (1)

Beijing Chaoyang District Centers for Disease Control and Prevention

Beijing, China

Location

MeSH Terms

Conditions

Chickenpox

Interventions

Chickenpox Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Nianmin Shi

  Beijing Chaoyang District Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 12, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: April 1, 2018
• Last Updated: May 29, 2013

Record last verified: 2013-04

Locations

CN (1)