A Study of the Safety of IMOVAX Polio™ in China
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ClinicalTrials.gov Identifier: NCT01244464 |
Recruitment Status
:
Completed
First Posted
: November 19, 2010
Last Update Posted
: August 3, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Poliomyelitis Polio | Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 800 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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™
|
- 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 ]Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.

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Ages Eligible for Study: | 60 Days to 89 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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): NCT01244464
China | |
Shanghai, China |
Study Director: | Medical Director | Sanofi Pasteur China |
Additional Information:
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01244464 History of Changes |
Other Study ID Numbers: |
IPV29 UTN: U1111-1114-3719 ( Other Identifier: WHO ) |
First Posted: | November 19, 2010 Key Record Dates |
Last Update Posted: | August 3, 2012 |
Last Verified: | August 2012 |
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 |