Trial record 6 of 162 for:    "Poliomyelitis"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01278433
First received: January 14, 2011
Last updated: March 28, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Polio
Poliomyelitis
Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. [ Time Frame: Up to 30 days after each vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 5007
Study Start Date: December 2010
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

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.

  Eligibility

Ages Eligible for Study:   60 Days to 89 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278433

Locations
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
Study Director: Medical Director Sanofi Pasteur China
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01278433     History of Changes
Other Study ID Numbers: IPV34, UTN: U1111 1115 6566
Study First Received: January 14, 2011
Last Updated: March 28, 2013
Health Authority: China: Ministry of Health

Keywords provided by Sanofi:
Polio
Poliovirus
IMOVAX Polio

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

ClinicalTrials.gov processed this record on April 17, 2014