A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
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|ClinicalTrials.gov Identifier: NCT01278433|
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 29, 2013
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The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.
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 or disease||Intervention/treatment||Phase|
|Polio Poliomyelitis||Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5007 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||June 2012|
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™
- Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. [ Time Frame: Up to 30 days after each 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.
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|Ages Eligible for Study:||60 Days to 89 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278433
|Beijing, Beijing, China, 100050|
|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|
|Study Director:||Medical Director||Sanofi Pasteur China|
|Responsible Party:||Sanofi Pasteur, a Sanofi Company|
|Other Study ID Numbers:||
UTN: U1111 1115 6566 ( Other Identifier: WHO )
|First Posted:||January 17, 2011 Key Record Dates|
|Last Update Posted:||March 29, 2013|
|Last Verified:||March 2013|
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