A Study of the Safety of IMOVAX Polio™ in China
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|ClinicalTrials.gov Identifier: NCT01244464|
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : August 3, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis Polio||Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: Study Group||
Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Other Name: IMOVAX POLIO™
- The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. [ Time Frame: Day 0 to Day 30 post-vaccination ]Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244464
|Study Director:||Medical Director||Sanofi Pasteur China|