Back to resultsStudy in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
Mencevax™ ACWY
Meningitec™
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Meningococcal serogroups A, C, W-135 and/or Y diseases, Conjugate vaccine, Immunogenicity, Meningococcal vaccine, Persistence, Non-inferiority
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
- A male or female between, and including, 1 through 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
Exclusion Criteria:
For the primary phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
- History of meningococcal disease due to serogroup A, C, W, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
For the long term persistence phase:
- History of meningococcal serogroup A, C, W, and/or Y disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A
Group B
Arm Description
All subjects received GSK Biolgicals' meningococcal vaccine 134612.
Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
Outcomes
Primary Outcome Measures
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response
Vaccine response was defined as:
for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32
for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Secondary Outcome Measures
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values
The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Anti-PS Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.
Anti-PS Antibody Concentrations
Antibody concentrations were presented as micrograms per milliliter (μg/mL).
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-TT Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Number of Subjects With Anti-TT Antibody Concentrations
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-TT Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in μg/mL.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value
The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Anti-PS Antibody Concentrations
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Anti-PS Antibody Concentrations
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
rSBA Antibody Titers (HPA Laboratory Assay)
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
rSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Rash
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Number of Subjects With Unsolicited AEs
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427908
Brief Title
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Official Title
Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 7, 2007 (Actual)
Primary Completion Date
December 3, 2007 (Actual)
Study Completion Date
December 3, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.
Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Detailed Description
Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Meningococcal serogroups A, C, W-135 and/or Y diseases, Conjugate vaccine, Immunogenicity, Meningococcal vaccine, Persistence, Non-inferiority
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
613 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
All subjects received GSK Biolgicals' meningococcal vaccine 134612.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.
Intervention Type
Biological
Intervention Name(s)
GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
Intervention Description
One intramuscular dose.
Intervention Type
Biological
Intervention Name(s)
Mencevax™ ACWY
Intervention Description
One subcutaneous dose.
Intervention Type
Biological
Intervention Name(s)
Meningitec™
Intervention Description
One intramuscular dose.
Primary Outcome Measure Information:
Title
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibodies Vaccine Response
Description
Vaccine response was defined as:
for initially seronegative subjects, post vaccination rSBA titer ≥ 1:32
for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.
Time Frame
One Month after vaccination
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) vaccination
Title
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) to vaccination
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
One month after vaccination [PI(M1)]
Title
Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
One month after vaccination [PI(M1)]
Secondary Outcome Measure Information:
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values
Description
The cut-off value for the rSBA titers were greater than or equal to ≥ 1:8 and ≥ 1:128. These analyses were performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE) and one month post vaccination [PI(M1)]
Title
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and (≥) 2.0 μg/mL.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations were presented as micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE) and one month post vaccination [PI(M1)]
Title
Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Anti-TT Antibody Concentrations
Description
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Number of Subjects With Anti-TT Antibody Concentrations
Description
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Anti-TT Antibody Concentrations
Description
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time Frame
Prior to (PRE) and one month post vaccination [PI(M1)]
Title
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE) and one month after vaccination [PI(M1)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE) and one month post vaccination [PI(M1)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations are presented as GMCs and expressed in μg/mL.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Title
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value
Description
The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Anti-PS Antibody Concentrations
Description
Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Title
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
At Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
At Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
At Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers (HPA Laboratory Assay)
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
At Persistence Year 4 [PI(M48)]
Title
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Title
Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Title
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
Description
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Title
rSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.
Time Frame
Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]
Title
Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value
Description
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Title
hSBA Antibody Titers
Description
Antibody titers are presented as geometric mean titers (GMTs).
Time Frame
Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Title
Number of Subjects With Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.
Time Frame
During the 4-day (Day 0-3) follow-up period
Title
Number of Subjects With Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 4-day (Day 0-3) follow-up period
Title
Number of Subjects With Rash
Description
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Time Frame
From administration of the vaccine dose until 6 months later
Title
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
Description
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame
From administration of the vaccine dose until 6 months later
Title
Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit
Description
Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.
Time Frame
From administration of the vaccine dose until 6 months later
Title
Number of Subjects With Unsolicited AEs
Description
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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame
During the 31-day (Days 0-30) post-vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
Up to 6 Months after vaccination
Title
Number of Subjects With SAE(s)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From 6 Months after vaccination up to Year 1
Title
Number of Subjects With SAE(s)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From 6 Months after vaccination up to Year 2
Title
Number of Subjects With SAE(s)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From 6 Months following vaccination up to Year 3
Title
Number of Subjects With SAE(s)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From 6 Months following vaccination up to Year 4
Title
Number of Subjects With SAE(s)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
From 6 Months following vaccination up to Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
A male or female between, and including, 1 through 10 years of age at the time of vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
Exclusion Criteria:
For the primary phase:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
History of meningococcal disease due to serogroup A, C, W, or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
For the long term persistence phase:
History of meningococcal serogroup A, C, W, and/or Y disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
GSK Investigational Site
City
Helsinki
ZIP/Postal Code
00930
Country
Finland
Facility Name
GSK Investigational Site
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
23032168
Citation
Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012 Dec 1;8(12):1882-91. doi: 10.4161/hv.22165. Epub 2012 Oct 2.
Results Reference
background
PubMed Identifier
23032159
Citation
Vesikari T, Forsten A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012 Dec 1;8(12):1892-903. doi: 10.4161/hv.22166. Epub 2012 Oct 2.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108658
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study is summarised with long term immunogenicity studies 108660 (year 1), 108661 (year 2), 108663 (year 3) and 108665 (year 4) on the GSK Cli
Learn more about this trial
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
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