A Study of the Safety of IMOVAX Polio™ in China

Phase 4

Completed

• Conditions: Poliomyelitis; Polio
• Interventions: Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

• Registration Number: NCT01244464
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Study participants will receive a single dose of IMOVAX Polio™ vaccine at 2, 3, and 4 months of age, respectively. Each participant will make a total of 7 visits. Safety will be monitored at each visit and up to 30 days after each vaccination.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-02
• Last Update Posted: 2012-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Group	IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine	-

Primary Outcome Measures

Name	Time	Method
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.