A Study of the Safety of IMOVAX Polio™ in China
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01244464
First received: November 17, 2010
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Poliomyelitis Polio |
Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study |
Resource links provided by NLM:
MedlinePlus related topics:
Polio and Post-Polio Syndrome
Drug Information available for:
Rabies Vaccine
U.S. FDA Resources
Further study details as provided by Sanofi:
Primary Outcome Measures:
- The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. [ Time Frame: Day 0 to Day 30 post-vaccination ] [ Designated as safety issue: No ]Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
| Enrollment: | 800 |
| Study Start Date: | November 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Study Group |
Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Other Name: IMOVAX POLIO™
|
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.
Eligibility| Ages Eligible for Study: | 60 Days to 89 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244464
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244464
Locations
| China | |
| Shanghai, China | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur China |
More Information
Additional Information:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01244464 History of Changes |
| Other Study ID Numbers: | IPV29 UTN: U1111-1114-3719 |
| Study First Received: | November 17, 2010 |
| Last Updated: | August 2, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Sanofi:
|
Poliomyelitis IMOVAX POLIO™ Polio |
Additional relevant MeSH terms:
|
Poliomyelitis Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Myelitis |
Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |
ClinicalTrials.gov processed this record on September 29, 2016