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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: July 9, 2009
Last updated: May 18, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Biological: Poliorix™
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ]

Enrollment: 25
Actual Study Start Date: August 4, 2009
Study Completion Date: November 13, 2009
Primary Completion Date: November 13, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPV Group Biological: Poliorix™
Three dose, intramuscular administration


Ages Eligible for Study:   60 Days to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
  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 identifier: NCT00937404

China, Guangxi
GSK Investigational Site
Wuzhou, Guangxi, China
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: GlaxoSmithKline Identifier: NCT00937404     History of Changes
Other Study ID Numbers: 112581
Study First Received: July 9, 2009
Last Updated: May 18, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases processed this record on May 25, 2017