Safety of Imovax Polio in Chinese Infants and Children

Study Overview
=================
Brief Summary
-----------------
To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.

Official Title
-----------------
Clinical Safety Evaluation Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children, and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.

Conditions
-----------------
Poliomyelitis

Intervention / Treatment
-----------------
* Biological: Inactivated Poliomyelitis vaccine
* Biological: Inactivated Poliomyelitis vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1: Aged 18 months (18-20 months) on the day of inclusion Group 2: Aged 2 months (56-70 days) on the day of inclusion Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Chronic illness at a stage that could interfere with trial conduct or completion Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2) Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B [Hep B] for Group 2) Vaccination planned in the 4 weeks following the trial vaccination Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine. History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically) Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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: Group 1<br>Children at 18 months of age | Biological: Inactivated Poliomyelitis vaccine<br>* 0.5 mL, intramuscular (IM)<br>* Other names: IMOVAX Polio™ (IPV);|
| Experimental: Group 2<br>Infants at 2 months of age | Biological: Inactivated Poliomyelitis vaccine<br>* 0.5 mL, IM<br>* Other names: IMOVAX Polio ™ (IPV);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IMOVAX;, poliomyelitis