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Trial record 97 of 80507 for:    subjects

Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01641042
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 12, 2012
First Posted Date  ICMJE July 16, 2012
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE October 18, 2017
Last Update Posted Date October 18, 2017
Study Start Date  ICMJE September 10, 2012
Actual Primary Completion Date October 10, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies [ Time Frame: One month after the first vaccine dose (at Month 1) ]
    Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
  • Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies [ Time Frame: One month after the first vaccine dose (at Month 1) ]
    Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Immunogenicity with respect to components of the investigational vaccine in terms of vaccine response [ Time Frame: One month after the first vaccine dose (at Month 1). ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of vaccine response [ Time Frame: One month after the second vaccine dose (at Month 3). ]
Change History Complete list of historical versions of study NCT01641042 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2017)
  • Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies [ Time Frame: One month after the second vaccine dose (At Month 3) ]
    Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
  • Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies [ Time Frame: One month after the second vaccine dose (At Month 3) ]
    Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    The cut-off value for the assay was ≥ 1:8.
  • Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3 ]
    The cut-off value for the assay was ≥ 1:128.
  • Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens [ Time Frame: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.
  • Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    The cut-off value for the assay was ≥ 1:4.
  • Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values [ Time Frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    The cut-off value for the assay ≥ 1:8.
  • Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens [ Time Frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3 ]
    Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.
  • Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values [ Time Frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).
  • Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values [ Time Frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    The cut-off value for the assay was ≥ 2.0 μg/mL.
  • Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens [ Time Frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) ]
    Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.
  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
  • Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses ]
    Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.
  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) [ Time Frame: From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8) ]
    NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
  • Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post first vaccination period ]
    An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
  • Number of Subjects Reporting Any Unsolicited AEs [ Time Frame: During the 31-day (Days 0-30) post second vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: From Month 0 until the end of the ESFU (at Month 8) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2012)
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody titres [ Time Frame: Just before and after the first vaccine dose and after the second vaccine dose (At Month 0, Month 1 and Month 3). ]
  • Immunogenicity with respect to components of the investigational vaccine in terms of antibody concentrations [ Time Frame: Just before and after the first vaccine dose and after the second vaccine dose (At Month 0, Month 1 and Month 3). ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 to Day 3) after each vaccine dose. ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 to Day 30) after each vaccine dose. ]
  • Occurrence of serious adverse events [ Time Frame: From the first dose until the end of the extended safety follow-up period (From Month 0 up to Month 8). ]
  • Occurrence of new onset of chronic illnesses (From Month 0 up to Month 8) [ Time Frame: From the first dose until the end of the extended safety follow-up period. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
Official Title  ICMJE Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered to at Risk Subjects From 1 to Less Than 18 Years
Brief Summary The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Detailed Description For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infections, Meningococcal
Intervention  ICMJE Biological: Meningococcal vaccine GSK134612
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Study Arms  ICMJE
  • Experimental: Healthy Group
    The subjects in the Healthy group will be age-matched to the subjects in the At-risk group. Subjects will receive 2 doses of the investigational vaccine.
    Intervention: Biological: Meningococcal vaccine GSK134612
  • Experimental: At-risk Group
    This group includes subjects with medical conditions placing them at an increased risk for meningococcal disease. Subjects will receive 2 doses of the investigational vaccine.
    Intervention: Biological: Meningococcal vaccine GSK134612
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2014)
86
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2012)
100
Actual Study Completion Date  ICMJE March 3, 2015
Actual Primary Completion Date October 10, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol.
  • A male or female 1 to 17 years of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if

    • the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose.

Additional inclusion criterion for At-risk group • Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies.

Additional inclusion criteria for Healthy group

  • Healthy subject as established by medical history and clinical examination before entering into the study.
  • Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8).
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations.
  • 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.
  • History of meningococcal disease.
  • Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex.
  • Major congenital defects.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrolment.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Additional exclusion criteria for the At-risk group

• Vaccination against meningococcal disease of any serogroup

  • within the last 3 years for subjects younger than 7 years.
  • within the last 5 years for subjects 7 years and older.

Additional exclusion criteria for the Healthy group

  • Vaccination against meningococcal disease of any serogroup with polysaccharide or conjugate vaccine within the last 5 years.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
  • Family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition.
  • Serious chronic illness.
  • History of asplenia or hyposplenia or complement deficiencies.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01641042
Other Study ID Numbers  ICMJE 115524
2011-002410-36 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2017

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