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

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

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.

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.

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.