A Study of the Safety of IMOVAX Polio™ in China
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.
|Poliomyelitis Polio||Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study|
- 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.
|Study Start Date:||November 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|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™
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244464
|Study Director:||Medical Director||Sanofi Pasteur China|