Status:
COMPLETED
A Study of the Safety of IMOVAX Polio™ in China
Lead Sponsor:
Sanofi
Conditions:
Poliomyelitis
Polio
Eligibility:
All Genders
60-89 years
Phase:
PHASE4
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,...
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 visi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT01244464
Start Date
November 1 2010
End Date
December 1 2011
Last Update
August 3 2012
Active Locations (1)
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1
Shanghai, China