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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01830283
Enrollment
50000
Registered
2013-04-12
Start date
2013-04-30
Completion date
2018-04-30
Last updated
2013-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicella

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.

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.

Interventions

The providers would get varicella vaccine

Sponsors

Beijing Center for Disease Control and Prevention
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of varicella after 2 dose vaccination5 yearsDetection the Varicella virus origin and virus types from illness cases in Chao yang district

Secondary

MeasureTime frameDescription
Adverse event rate of varicella vaccine after 2 dose injection5 yearsAdverse event rate of varicella vaccine after 2 dose injection

Other

MeasureTime frameDescription
Antibody titre of varicella vaccine after 2 dose injection6 monthesAntibody titre of varicella vaccine after 2 dose injection

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026