A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study

Conditions
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Polio, Poliomyelitis

Intervention / Treatment
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* Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Days
Maximum Age: 89 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants receiving their first dose of polio vaccine | Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine<br>* 0.5 mL, Intramuscular<br>* Other names: IMOVAX Polio™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting serious adverse events and relationship to Imovax Polio 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. | Up to 30 days after each vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polio, Poliovirus, IMOVAX Polio™