A Study of the Safety of IMOVAX Polio™ in China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01244464
First received: November 17, 2010
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Poliomyelitis
Polio
Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety Study of IMOVAX Polio™ in Selected Cities in China, an Observational Post Marketing Study

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The occurrence, duration, and relationship to vaccination of solicited and unsolicited (spontaneously reported) adverse events occurring after IMOVAX Polio™ vaccination. [ Time Frame: Day 0 to Day 30 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.


Enrollment: 800
Study Start Date: November 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group Biological: IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine
0.5 mL, at 2, 3, and 4 months; Intramuscular
Other Name: IMOVAX POLIO™

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244464

Locations
China
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur China
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01244464     History of Changes
Other Study ID Numbers: IPV29, UTN: U1111-1114-3719
Study First Received: November 17, 2010
Last Updated: August 2, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sanofi:
Poliomyelitis
IMOVAX POLIO™
Polio

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 21, 2014