Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
800 participants
INTERVENTIONAL
2010-11-30
2011-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study Group
IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Interventions
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IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Days
89 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur China
Locations
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Shanghai, , China
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1114-3719
Identifier Type: OTHER
Identifier Source: secondary_id
IPV29
Identifier Type: -
Identifier Source: org_study_id