A Study of the Safety of IMOVAX Polio™ in China

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Poliomyelitis; Polio	Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	800 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
Study Start Date :	November 2010
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	December 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Study Group	Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine; 0.5 mL, at 2, 3, and 4 months; Intramuscular; Other Name: IMOVAX POLIO™

Outcome Measures

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Primary Outcome Measures :

1. The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	60 Days to 89 Days (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

• Subject is more than 2 months (60-89 days) old when receiving the first dose of polio vaccine.
• Subject's parents/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 from 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 (e.g., hypersensitivity, seizure, convulsion, encephalopathy diseases)
• Known or suspected impairment of immunologic function
• Acute medical illness with or without fever within the last 72 hours
• Subject plan to leave the study sites for at least three months after inclusion
• Administration of immune globulin or other blood products within the last three months
• Participation in another clinical trial at the same time
• Contraindication to vaccination according to IMOVAX Polio™ leaflet.

Contacts and Locations

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Locations

China
Shanghai, China

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	Medical Director	Sanofi Pasteur China

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Related Info 

Related Info 

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01244464 History of Changes
Other Study ID Numbers:	IPV29; UTN: U1111-1114-3719 ( Other Identifier: WHO )
First Posted:	November 19, 2010
Last Update Posted:	August 3, 2012
Last Verified:	August 2012

Keywords provided by Sanofi:

Poliomyelitis; IMOVAX POLIO™; Polio

Additional relevant MeSH terms:

Poliomyelitis; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Myelitis	Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuromuscular Diseases