Clinical Trial: Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix™) in Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-label Primary Vaccination Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as

Brief Summary: The study will evaluate the safety and reactogenicity of PoliorixTM given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 4-day follow-up period after each dose of study vaccine. ]
  • Occurrence of unsolicited symptoms. [ Time Frame: During the 31-days follow-up period after each dose of the study vaccine. ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: From Dose 1 up to one month following last vaccine dose. ]


Original Primary Outcome:

  • Occurrence of unsolicited symptoms. [ Time Frame: During the 31-days follow-up period after each dose of the study vaccine. ]
  • Occurrence of serious adverse events (SAEs). [ Time Frame: From Dose 1 up to one month following last vaccine dose. ]
  • Occurrence of solicited local and general symptoms. [ Time Frame: During the 4-day follow-up period after each dose of study vaccine. ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: GlaxoSmithKline

Dates:
Date Received: July 9, 2009
Date Started: August 4, 2009
Date Completion:
Last Updated: May 18, 2017
Last Verified: May 2017