A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
NCT ID: NCT01278433
Last Updated: 2013-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
5007 participants
INTERVENTIONAL
2010-12-31
2012-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study Group
Participants receiving their first dose of polio vaccine
IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
0.5 mL, Intramuscular
Interventions
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IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Days
89 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur China
Locations
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Beijing, Beijing Municipality, China
Changsha, , China
Chengdu, , China
Chongqing, , China
Hangzhou, , China
Jinan, , China
Kunming, , China
Nanjing, , China
Qingdao, , China
Shenyang, , China
Shenzhen, , China
Tianjin, , China
Wuhan, , China
Xi'an, , China
Zheng Zho, , China
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111 1115 6566
Identifier Type: OTHER
Identifier Source: secondary_id
IPV34
Identifier Type: -
Identifier Source: org_study_id