A Study of the Safety of IMOVAX Polio™ in China
|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|
|Primary Completion Date :||June 2011|
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244464
|Study Director:||Medical Director||Sanofi Pasteur China|