A Study of the Safety of IMOVAX Polio™ in China | NCT01244464

Studies
A Study of the Safety of IMOVAX Polio™ in China

NCT01244464

Sponsor

Sanofi

Status

Completed

Last Update Posted

Aug 3, 2012Estimated

Enrollment

800Actual

Phase

Phase 4

Conditions

Poliomyelitis
Polio

Interventions

IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UTN: U1111-1114-3719	Other Identifier	WHO

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Jun 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 17, 2010

First Submission Date that Met QC Criteria

Nov 18, 2010

First Posted Date

Nov 19, 2010Estimated

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

Aug 2, 2012

Last Update Posted Date

Aug 3, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is designed to obtain post-marketing safety data on IMOVAX Polio™ vaccine in China.

Primary Objective: To describe the safety profile after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age in population aged over 2 months old living in the study city China.

Detailed Description

Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.

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

800Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study Group	Experimental		Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine	Biological	0.5 mL, at 2, 3, and 4 months; Intramuscular	Study Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.	Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.	Day 0 to Day 30 post-vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
Subject's parents/legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio™ according to the schedule: one injection at 2, 3, 4 months old, respectively.
Informed consent form obtained from the subject's parent/legal representative.
Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion Criteria :

Subject with a history of serious illness (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours
Subject plan to leave the study sites for at least three months after inclusion
Administration of immune globulin or other blood products within the last three months
Participation in another clinical trial at the same time
Contraindication to vaccination according to IMOVAX Polio™ leaflet.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Days

Maximum Age

89 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Sanofi Pasteur China	Study Director

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D011051	Poliomyelitis

Ancestor Terms

ID	Term
D009187	Myelitis
D002494	Central Nervous System Infections
D007239	Infections
D004769	Enterovirus Infections

Browse Leaves

Not provided

Browse Branches

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