Who is sponsoring NCT01244464?

NCT01244464 is sponsored by Sanofi.

What condition does NCT01244464 study?

NCT01244464 studies Poliomyelitis, Polio.

What drugs are being tested in NCT01244464?

Interventions: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine.

What is the status of NCT01244464?

NCT01244464 is currently COMPLETED.

Last reviewed 2012-08-02 · How we verify

Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study

NCT01244464 Phase 4 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	COMPLETED
Enrolment	800
Start date	2010-11
Completion	2011-12

Conditions

Poliomyelitis
Polio

Interventions

IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

Primary outcomes

The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. — 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.

Countries

China