Safety of Imovax Polio in Chinese Infants and Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00258843
First received: November 24, 2005
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Poliomyelitis
Biological: Inactivated Poliomyelitis vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Enrollment: 40
Study Start Date: November 2005
Study Completion Date: April 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   2 Months to 18 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258843

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

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00258843     History of Changes
Other Study ID Numbers: IPV17
Study First Received: November 24, 2005
Last Updated: January 20, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
IMOVAX;
poliomyelitis

Additional relevant MeSH terms:
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Enterovirus Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014