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Safety of Imovax Polio in Chinese Infants and Children

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ClinicalTrials.gov Identifier: NCT00258843
Recruitment Status : Completed
First Posted : November 28, 2005
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: Inactivated Poliomyelitis vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
Study Start Date : November 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : April 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Children at 18 months of age
 Biological: Inactivated Poliomyelitis vaccine
0.5 mL, intramuscular (IM)
Other Name: IMOVAX Polio™ (IPV)
Experimental: Group 2
Infants at 2 months of age
 Biological: Inactivated Poliomyelitis vaccine
0.5 mL, IM
Other Name: IMOVAX Polio ™ (IPV)


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   2 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1: Aged 18 months (18-20 months) on the day of inclusion
  • Group 2: Aged 2 months (56-70 days) on the day of inclusion

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion
  • Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
  • Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2)
  • Vaccination planned in the 4 weeks following the trial vaccination
  • Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
  • Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
  • History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
  • Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
  • Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
  • History of/current seizures
  • Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
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): NCT00258843


Locations
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China
Pingle, China
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Trials Sanofi Pasteur, a Sanofi Company
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00258843    
Other Study ID Numbers: IPV17
First Posted: November 28, 2005    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
IMOVAX;
poliomyelitis
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
Vaccines
Immunologic Factors
Physiological Effects of Drugs