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A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

Primary Purpose

Polio, Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polio focused on measuring Polio, Poliovirus, IMOVAX Polio™

Eligibility Criteria

60 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
  • Subject's parent /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 by 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 (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
  • Acute medical illness with or without fever within the last 72 hours.
  • Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
  • Participation in another clinical trial at the same time.
  • Contraindications to vaccination according to IMOVAX Polio™ leaflet.
  • Subject plan to leave the study sites for at least three months after inclusion.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

Participants receiving their first dose of polio vaccine

Outcomes

Primary Outcome Measures

Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2011
Last Updated
March 28, 2013
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01278433
Brief Title
A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
Official Title
Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China. Objective: To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.
Detailed Description
Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polio, Poliomyelitis
Keywords
Polio, Poliovirus, IMOVAX Polio™

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5007 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
Participants receiving their first dose of polio vaccine
Intervention Type
Biological
Intervention Name(s)
IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
Other Intervention Name(s)
IMOVAX Polio™
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
Description
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.
Time Frame
Up to 30 days after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine. Subject's parent /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 by 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 (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.) Acute medical illness with or without fever within the last 72 hours. Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine) Participation in another clinical trial at the same time. Contraindications to vaccination according to IMOVAX Polio™ leaflet. Subject plan to leave the study sites for at least three months after inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur China
Official's Role
Study Director
Facility Information:
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
City
Chang Sha
Country
China
City
Cheng Du
Country
China
City
Chong Qing
Country
China
City
Hang Zhou
Country
China
City
Ji Nan
Country
China
City
Kun Ming
Country
China
City
Nan Jing
Country
China
City
Qing Dao
Country
China
City
Shen Yang
Country
China
City
Shen Zhen
Country
China
City
Tian Jin
Country
China
City
Wu Han
Country
China
City
Xi An
Country
China
City
Zheng Zho
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

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