Study on Effectiveness of 2-dose Live Attenuated Varicell... | NCT02146469

Studies
Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

NCT02146469

Sponsor

Shanghai Municipal Center for Disease Control and Prevention

Status

Unknown status

Last Update Posted

May 23, 2014Estimated

Enrollment

1,200Estimated

Phase

Phase 4

Conditions

Varicella

Interventions

2 doses with an 3 months interval
A second dose with an 1 year interval
A second dose with an 3 year interval
A second dose with an 5 year interval
1 dose Varicella vaccine and 1 dose MMR given at the same time
1 dose MMR

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2014

Last Update Posted Date

May 23, 2014Estimated

Name	Class
Shanghai Institute Of Biological Products	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
None varicella vaccine history	Experimental	2 doses with an 3 months interval	Biological: 2 doses with an 3 months interval
1 year after first dose	Experimental	A second dose with an 1 year interval	Biological: A second dose with an 1 year interval
3 years after first dose	Experimental	A second dose with an 3 year interval	Biological: A second dose with an 3 year interval
5 years after first dose	Experimental	A second dose with an 5 year interval	Biological: A second dose with an 5 year interval
Testing group for conbined immunization	Experimental	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
Control group for conbined immunization	Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2 doses with an 3 months interval	Biological	varicella vaccination	None varicella vaccine history

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Seroconversion rate and GMCs after varicella vaccination		35-42 days after each dose vaccination

Secondary Outcomes

Measure	Description	Time Frame
The incidence of Adverse Events Following Immunization		30 days after each dose vaccination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiaodong Sun	Shanghai Municipal Center for Disease Control and Prevention	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai municipal center for disease control and prevention		Shanghai	Shanghai Municipality	021	China

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Term
D022283	Herpesvirus Vaccines
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures