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A Study of the Safety of IMOVAX Polio™ in China

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ClinicalTrials.gov Identifier: NCT01244464
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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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

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Arms and Interventions
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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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244464


Locations
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China
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Director Sanofi Pasteur China
More Information
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Additional Information:
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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    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012
Keywords provided by Sanofi:
Poliomyelitis
IMOVAX POLIO™
Polio
Additional relevant MeSH terms:
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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