A Study of the Safety of IMOVAX Polio™ in China

Sanofi

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Polio

Treatments

Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244464

IPV29

UTN: U1111-1114-3719 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

800 patients

Sex

All

Ages

60 to 89 days old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.