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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Polio

Treatments

Biological: IMOVAX Polio™: Inactivated Poliomyelitis Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01278433

UTN: U1111 1115 6566 (Other Identifier)

IPV34

Details and patient eligibility

About

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.

Full description

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.

Enrollment

5,007 patients

Sex

All

Ages

60 to 89 days old

Volunteers

Accepts Healthy Volunteers

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.