Back to resultsA Study of the Safety of IMOVAX Polio™ in China
Primary Purpose
Poliomyelitis, Polio
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Poliomyelitis focused on measuring Poliomyelitis, IMOVAX POLIO™, Polio
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Group
Arm Description
Outcomes
Primary Outcome Measures
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01244464
Brief Title
A Study of the Safety of IMOVAX Polio™ in China
Official Title
Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis, Polio
Keywords
Poliomyelitis, IMOVAX POLIO™, Polio
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
Other Intervention Name(s)
IMOVAX POLIO™
Intervention Description
0.5 mL, at 2, 3, and 4 months; Intramuscular
Primary Outcome Measure Information:
Title
The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.
Description
Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Time Frame
Day 0 to Day 30 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur China
Official's Role
Study Director
Facility Information:
City
Shanghai
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
A Study of the Safety of IMOVAX Polio™ in China
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