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Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01021293
First received: November 25, 2009
Last updated: March 28, 2013
Last verified: February 2011

November 25, 2009
March 28, 2013
November 2009
July 2010   (final data collection date for primary outcome measure)
Immunogenicity with respect to the components of the study vaccines [ Time Frame: One month after the third dose of primary vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021293 on ClinicalTrials.gov Archive Site
  • Immunogenicity with respect to the components of the study vaccines [ Time Frame: Prior to the first dose and one month after the third dose of primary vaccination ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period following each dose of the study vaccines ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Poliomyelitis
  • Poliomyelitis Vaccines
  • Biological: Poliorix™
    3 doses, intramuscular administration
  • Biological: Oral Poliovirus vaccine
    3 doses, oral administration
  • Experimental: Poliorix Group
    Subjects will be administered Poliorix™ at 2, 3 and 4 months of age.
    Intervention: Biological: Poliorix™
  • Active Comparator: Control Group
    Subjects will be administered an oral poliovirus vaccine at 2, 3 and 4 months of age.
    Intervention: Biological: Oral Poliovirus vaccine
Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1101
July 2010
July 2010   (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 parent(s)/Legally Acceptable Representative (LAR) (s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) 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 any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • Child in care.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if 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.

Both
60 Days to 90 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01021293
112679
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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