This study is intended to support the registration of IMOVAX Polio in China. The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
0.5 mL, Intramuscular
1g dragee, oral
Unnamed facility
Guilin, China
Unnamed facility
PingLe County, China
To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine
Time frame: 1 month post-vaccination 3
To provide information concerning the safety of IMOVAX Polio™ vaccine
Time frame: Entire study period
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