A Study of the Safety of IMOVAX Polio™ in China

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244464
• Other study ID #: IPV29
• Secondary ID: UTN: U1111-1114-
• Status: Completed
• Phase: Phase 4
• First received: November 17, 2010
• Last updated: August 2, 2012
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Days to 89 Days

Eligibility

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.

Study Design

Allocation: Non-Randomized, 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 types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination.	Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.	Day 0 to Day 30 post-vaccination	No

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