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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00937404
First received: July 9, 2009
Last updated: May 26, 2017
Last verified: May 2017
July 9, 2009
May 26, 2017
August 4, 2009
November 13, 2009   (Final data collection date for primary outcome measure)
  • 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. ]
  • 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. ]
Complete list of historical versions of study NCT00937404 on ClinicalTrials.gov Archive Site
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Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix™) in Infants
An Open-label Primary Vaccination Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Three-dose Primary Vaccination Course at 2, 3 and 4 Months of Age in Healthy Infants in China.
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Poliomyelitis
Biological: Poliorix™
Three dose, intramuscular administration
Experimental: IPV Group
Intervention: Biological: Poliorix™
Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 13, 2009
November 13, 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Evidence of previous or intercurrent poliomyelitis disease or vaccination.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
  • Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
Sexes Eligible for Study: All
60 Days to 90 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT00937404
112581
Not Provided
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Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP