A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
This study has been completed.
Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01278433
First received: January 14, 2011
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polio Poliomyelitis |
Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination. [ Time Frame: Up to 30 days after each vaccination ] [ Designated as safety issue: No ]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.
| Enrollment: | 5007 |
| Study Start Date: | December 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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™
|
Detailed Description:
Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.
Eligibility| Ages Eligible for Study: | 60 Days to 89 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278433
Locations
| China, Beijing | |
| Beijing, Beijing, China, 100050 | |
| China | |
| 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 | |
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur China |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
| ClinicalTrials.gov Identifier: | NCT01278433 History of Changes |
| Other Study ID Numbers: | IPV34, UTN: U1111 1115 6566 |
| Study First Received: | January 14, 2011 |
| Last Updated: | March 28, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Sanofi:
|
Polio Poliovirus IMOVAX Polio™ |
Additional relevant MeSH terms:
|
Poliomyelitis Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013