A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

Phase 4

Completed

• Conditions: Polio; Poliomyelitis

• Registration Number: NCT01278433
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

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.

Detailed Description

Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2011-12
• Study Completion: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5007

Inclusion Criteria

• Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
• Subject's parent /legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio according to the schedule. one injection at 2, 3, 4 months old respectively;
• Informed consent form obtained by the subject's parent/legal representative.
• Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion Criteria

• Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
• Acute medical illness with or without fever within the last 72 hours.
• Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
• Participation in another clinical trial at the same time.
• Contraindications to vaccination according to IMOVAX Polio™ leaflet.
• Subject plan to leave the study sites for at least three months after inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.