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NCT Number: NCT01244464

A Study of the Safety of IMOVAX Polio™ in China

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.

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Key information

Conditions

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

Age range

60 day–89 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

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

Other names: IMOVAX POLIO™

Primary outcomes

  1. 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

    Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 19, 2010
Registry last updated
Aug 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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