Who is sponsoring NCT01278433?

NCT01278433 is sponsored by Sanofi Pasteur, a Sanofi Company.

What condition does NCT01278433 study?

NCT01278433 studies Polio, Poliomyelitis.

What drugs are being tested in NCT01278433?

Interventions: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine.

What is the status of NCT01278433?

NCT01278433 is currently COMPLETED.

Last reviewed 2013-03-28 · How we verify

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

NCT01278433 Phase 4 COMPLETED

The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China. Objective: To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.

Details

Lead sponsor	Sanofi Pasteur, a Sanofi Company
Phase	Phase 4
Status	COMPLETED
Enrolment	5007
Start date	2010-12
Completion	2012-06

Conditions

Polio
Poliomyelitis

Interventions

IMOVAX Polio™: Inactivated Poliomyelitis Vaccine

Primary outcomes

Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. — Up to 30 days after each vaccination
A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.

Countries

China