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Trial record 1 of 1 for:    IPV29
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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

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 19, 2010
Last Update Posted Date August 3, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01244464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety of IMOVAX Polio™ in China
Official Title  ICMJE Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Poliomyelitis
  • Polio
Intervention  ICMJE 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™
Study Arms  ICMJE Experimental: Study Group
Intervention: Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2010)
800
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Days to 89 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01244464
Other Study ID Numbers  ICMJE IPV29
UTN: U1111-1114-3719 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur China
PRS Account Sanofi
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP