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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01278433
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 29, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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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.


Condition or disease Intervention/treatment Phase
Polio Poliomyelitis Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5007 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
Study Start Date : December 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study Group
Participants receiving their first dose of polio vaccine
 Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
0.5 mL, Intramuscular
Other Name: IMOVAX Polio™


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. [ Time Frame: 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.


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 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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01278433


Locations
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China, Beijing
Beijing, Beijing, China, 100050
China
Chang Sha, China
Cheng Du, China
Chong Qing, China
Hang Zhou, China
Ji Nan, China
Kun Ming, China
Nan Jing, China
Qing Dao, China
Shen Yang, China
Shen Zhen, China
Tian Jin, China
Wu Han, China
Xi An, China
Zheng Zho, China
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
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 Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01278433    
Other Study ID Numbers: IPV34
UTN: U1111 1115 6566 ( Other Identifier: WHO )
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: March 29, 2013
Last Verified: March 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Polio
Poliovirus
IMOVAX Polio™
Additional relevant MeSH terms:
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Poliomyelitis
Myelitis
Central Nervous System Infections
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuroinflammatory Diseases
Neuromuscular Diseases