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NCT Number: NCT01278433

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

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.

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Key information

Conditions

Polio Central Nervous System Diseases Central Nervous System Infections Enterovirus Infections Infections Myelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Picornaviridae Infections Poliomyelitis 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

Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

IMOVAX Polio™: Inactivated Poliomyelitis Vaccine

Biological

0.5 mL, Intramuscular

Other names: IMOVAX Polio™

Primary outcomes

  1. Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.

    Time frame: Up to 30 days after each 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.

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Large Scale 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
2012
First posted
Jan 17, 2011
Registry last updated
Mar 29, 2013

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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