A Study of the Safety of IMOVAX Polio™ in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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 types 1, 2, and 3 poliovirus D vaccine


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br> | Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine<br>* 0.5 mL, at 2, 3, and 4 months; Intramuscular<br>* Other names: IMOVAX POLIO™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. | Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability. | Day 0 to Day 30 post-vaccination | 

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