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

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278433
• Other study ID #: IPV34
• Secondary ID: UTN: U1111 1115
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: March 28, 2013
• Start date: December 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5007
• Est. completion date: June 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Days to 89 Days

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Polio
• Poliomyelitis

Intervention

Biological:
• IMOVAX Polio™: Inactivated Poliomyelitis Vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.	A serious adverse event is defined as any untoward medical occurrence that at any dose (including overdose) results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect, or is an important medical event.	Up to 30 days after each vaccination	No

External Links

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