Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study has been terminated.
(Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871741
First received: March 26, 2009
Last updated: November 16, 2012
Last verified: November 2012

March 26, 2009
November 16, 2012
April 2009
June 2009   (final data collection date for primary outcome measure)
Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00871741 on ClinicalTrials.gov Archive Site
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity of study vaccine antigens [ Time Frame: Before the third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local/general symptoms [ Time Frame: During the 8-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Haemophilus Influenzae Type b
  • Poliomyelitis
  • Hepatitis B
  • Serogroup C Meningococcal Diseases
  • Diphtheria
  • Pertussis
  • Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccines
  • Tetanus
  • Biological: GSK2202083A vaccine
    Intramuscular, three doses
  • Biological: Infanrix hexa
    Intramuscular, three doses
  • Biological: Menjugate
    Intramuscular, two doses
  • Experimental: Combo Group
    Intervention: Biological: GSK2202083A vaccine
  • Active Comparator: Control Group
    Interventions:
    • Biological: Infanrix hexa
    • Biological: Menjugate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A male or female infant between, and including, 8 and 16 weeks 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.
  • 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 randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
  • 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 diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
  • 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 if no other exclusion criteria is met:

• Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration

Both
8 Weeks to 16 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
NCT00871741
111761
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2012

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