Status unknownNCT02146469Updated May 23, 2014

Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

A Phase 4 interventional study of 2 doses with an 3 months interval and A second dose with an 1 year interval in Varicella, sponsored by Shanghai Municipal Center for Disease Control and Prevention. Status unknown at 1 site in China. Open to participants aged 1 Year to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-23.

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

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 1,200
Allocation: Non-randomized
Ages: 1 Year to 7 Years
Sex: All

Study summary

The objective of the study is as follows:

To know the antibody level during different interval after received 1 dose varicella vaccine.
To know safety and effectiveness of received 2 doses varicella vaccine with different interval.
To know safety and effectiveness of received varicella vaccine and MMR at the same time.

To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.

All blood specimens will be tested by a third-party detection institution.

Conditions studied

Varicella

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Keywords

varicella vaccination

In context

Chickenpox

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

This study's planned enrollment of 1,200 is above the median of 478 across 126 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Shanghai Municipal Center for Disease Control and Prevention is the lead sponsor of 2 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: 1 Year to 7 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Aged 1 to 7
Without a previous history of varicella
With an axillary temperature ≤37.5℃ at the time of vaccination
Appropriate varicella vaccination history
With guardian signing the informed consent and available for clinical observation

Exclusion criteria

Exclusion Criteria:

Hypersensitive to any active substance of the vaccine including excipients and antibiotics
With acute illness, severe or acute attack of chronic illness or fever
With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs
Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease
With a family or personal history of seizure, chronic illness, epilepsy or allergy
With unknown immunization history or unable to follow the immunization schedule of EPI
Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month
With hemorrhagic tendency or prolonged period of bleeding
Received whole blood, plasma or immunoglobulin within 5 months
Received systemic antibiotics or antiviral treatment for acute illness within 7 days
With an axillary temperature ≥38℃ within 3 days
Participating in another clinical trial
Any situation that might influence the consequence of the clinical trial

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,200 participants (estimated)

Study arms

Experimental
None varicella vaccine history
2 doses with an 3 months interval
Biological: 2 doses with an 3 months interval
Experimental
1 year after first dose
A second dose with an 1 year interval
Biological: A second dose with an 1 year interval
Experimental
3 years after first dose
A second dose with an 3 year interval
Biological: A second dose with an 3 year interval
Experimental
5 years after first dose
A second dose with an 5 year interval
Biological: A second dose with an 5 year interval
Experimental
Testing group for conbined immunization
1 dose Varicella vaccine and 1 dose MMR given at the same time
Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time
Placebo comparator
Control group for conbined immunization
1 dose MMR
Biological: 1 dose MMR

Interventions

Biological2 doses with an 3 months interval
varicella vaccination
BiologicalA second dose with an 1 year interval
varicella vaccine
BiologicalA second dose with an 3 year interval
varicella vaccine
BiologicalA second dose with an 5 year interval
varicella vaccine
Biological1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
Biological1 dose MMR
MMR

What researchers measure

Primary outcomes

Seroconversion rate and GMCs after varicella vaccination
Time frame: 35-42 days after each dose vaccination

Secondary outcomes

The incidence of Adverse Events Following Immunization
Time frame: 30 days after each dose vaccination

Study locations

1 site

Shanghai municipal center for disease control and prevention
Shanghai, Shanghai 021, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02146469
Lead sponsor: Shanghai Municipal Center for Disease Control and Prevention
Collaborators: Shanghai Institute Of Biological Products
Responsible party: Sponsor
First posted: May 23, 2014
Start date: Dec 2012
Primary completion: Jun 2014 (estimated)
Completion: Dec 2014 (estimated)
Last update: May 23, 2014

Study contacts

Xiaodong Sun

study director · Shanghai Municipal Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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