A Study of the Safety of IMOVAX Polio™ in China

NCT01244464 | Completed Phase 4

• 2 other identifiers: IPV29UTN: U1111-1114-3719
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poliomyelitis; Polio

Keywords

Poliomyelitis; IMOVAX POLIO™; Polio

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Study Group

EXPERIMENTAL

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

Interventions

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

0.5 mL, at 2, 3, and 4 months; Intramuscular

Also known as: IMOVAX POLIO™

Study Group

Eligibility Criteria

• Age: 60 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Shanghai, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Medical Director

  Sanofi Pasteur China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 19, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 3, 2012

Record last verified: 2012-08

Locations

CN (1)