A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
2 other identifiers
interventional
5,007
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2010
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 29, 2013
March 1, 2013
1 year
January 14, 2011
March 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
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.
Up to 30 days after each vaccination
Study Arms (1)
Study Group
EXPERIMENTALParticipants receiving their first dose of polio vaccine
Interventions
0.5 mL, Intramuscular
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Unknown Facility
Beijing, Beijing Municipality, 100050, China
Unknown Facility
Changsha, China
Unknown Facility
Chengdu, China
Unknown Facility
Chongqing, China
Unknown Facility
Hangzhou, China
Unknown Facility
Jinan, China
Unknown Facility
Kunming, China
Unknown Facility
Nanjing, China
Unknown Facility
Qingdao, China
Unknown Facility
Shenyang, China
Unknown Facility
Shenzhen, China
Unknown Facility
Tianjin, China
Unknown Facility
Wuhan, China
Unknown Facility
Xi'an, China
Unknown Facility
Zheng Zho, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 17, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2011
Study Completion
June 1, 2012
Last Updated
March 29, 2013
Record last verified: 2013-03