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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:
ClinicalTrials.gov Identifier:
NCT00871741
First Posted: March 30, 2009
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
March 26, 2009
March 30, 2009
February 16, 2017
April 4, 2017
May 11, 2017
April 1, 2009
June 25, 2009   (Final data collection date for primary outcome measure)
Anti-PRP Antibody Concentrations ≥ 0.15 mg/mL [ Time Frame: At Month 3 ]
As the study was terminated, no blood samples were taken. Hence no immunogenicity analyses were done.
Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ]
Complete list of historical versions of study NCT00871741 on ClinicalTrials.gov Archive Site
  • Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms [ Time Frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses ]

    The solicited local symptoms assessed were pain, redness and swelling. Any = any solicited local symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

    Subjects from Control Group did not receive the second study vaccination dose due to study termination.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses ]

    The solicited general symptoms assessed were drowsiness, irritability, loss of appetite and temperature.

    Any = any general symptom irrespective of intensity grade and relationship to vaccination.

    Grade 3 Irritability = crying that could not be comforted/prevented normal activity.

    Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Loss of Appetite = did not eat at all. Related = symptoms assessed by the investigator as causally related to vaccination.

    Subjects from Control Group did not receive the second study vaccination dose due to study termination.

  • Number of Subjects With Unsolicited Adverse Events AE(s) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Month 0 to Month 9) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the third vaccine dose ]
  • Immunogenicity of study vaccine antigens [ Time Frame: Before the third vaccine dose ]
  • Occurrence of solicited local/general symptoms [ Time Frame: During the 8-day follow-up period after each vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 up to study end ]
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ]
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Tetanus
  • Poliomyelitis
  • Neisseria Meningitidis
  • Haemophilus Influenzae Type b
  • Diphtheria
  • Acellular Pertussis
  • Hepatitis B
  • Biological: GSK2202083A vaccine
    Intramuscular, three doses
  • Biological: Infanrix hexa
    Intramuscular, three doses
  • Biological: Menjugate
    Intramuscular, two doses
  • Experimental: GSK2202083A GROUP
    Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
    Intervention: Biological: GSK2202083A vaccine
  • Active Comparator: INFANRIX + MENJUGATE GROUP
    Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
    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 25, 2009
June 25, 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

Sexes Eligible for Study: All
8 Weeks to 16 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
 
NCT00871741
111761
Not Provided
Not Provided
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
April 2017

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