Status unknownNCT01830283Updated May 29, 2013

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

A Phase 4 interventional study of varicella vaccine in Varicella, sponsored by Beijing Center for Disease Control and Prevention. Status unknown at 1 site in China. Open to participants aged 4 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-29.

Sponsored by Beijing Center for Disease Control and Prevention · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2013), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 50,000
Allocation: Non-randomized
Ages: 4 Years to 12 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Varicella

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In context

Chickenpox

152 studies on the registry are indexed under Chickenpox; 26 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 478 across 126 interventional studies indexed under Chickenpox.

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Lead sponsor

Beijing Center for Disease Control and Prevention is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 4 Years to 12 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 50,000 participants (estimated)

Study arms

Active comparator
1 dose varicella vaccine
The providers would get the 2nd dose since they had one dose varicella vaccine
Biological: varicella vaccine
Experimental
2 dose varicella vaccine
The provider never get the varicella vaccine
Biological: varicella vaccine

Interventions

Biologicalvaricella vaccine
The providers would get varicella vaccine

What researchers measure

Primary outcomes

Incidence of varicella after 2 dose vaccination
Detection the Varicella virus origin and virus types from illness cases in Chao yang district
Time frame: 5 years

Secondary outcomes

Adverse event rate of varicella vaccine after 2 dose injection
Adverse event rate of varicella vaccine after 2 dose injection
Time frame: 5 years

Other outcomes

Antibody titre of varicella vaccine after 2 dose injection
Antibody titre of varicella vaccine after 2 dose injection
Time frame: 6 monthes

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01830283
Lead sponsor: Beijing Center for Disease Control and Prevention
Responsible party: Sponsor
First posted: Apr 12, 2013
Start date: Apr 2013
Primary completion: Jun 2013 (estimated)
Completion: Apr 2018 (estimated)
Last update: May 29, 2013

Study contacts

Nianmin Shi

principal investigator · Beijing Chaoyang District Centers for Disease Control and Prevention

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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