Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

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)

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.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix); Biological: Mencevax™ ACWY; Biological: Meningitec™

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.

• Study Type: Interventional
• Enrollment (Actual): 613
• Phase: Phase 2

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02100
    • GSK Investigational Site
  • Helsinki, Finland, 00100
    • GSK Investigational Site
  • Helsinki, Finland, 00930
    • GSK Investigational Site
  • Jarvenpaa, Finland, 04400
    • GSK Investigational Site
  • Lahti, Finland, 15140
    • GSK Investigational Site
  • Oulu, Finland, 90100
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
  • Vantaa, Finland, 01300
    • GSK Investigational Site
  • Vantaa, Finland, 01600
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; All subjects received GSK Biolgicals' meningococcal vaccine 134612.	Biological: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix); One intramuscular dose.
Active Comparator: Group B; Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.	Biological: Mencevax™ ACWY; One subcutaneous dose.; Biological: Meningitec™; One intramuscular dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	One Month after 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.	Prior to (PRE) vaccination
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.	Prior to (PRE) to 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.	One month after vaccination [PI(M1)]
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.	One month after vaccination [PI(M1)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month after vaccination [PI(M1)]
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month post vaccination [PI(M1)]
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-PS Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-PS Antibody Concentrations	Antibody concentrations were presented as micrograms per milliliter (μg/mL).	Prior to (PRE) and one month post vaccination [PI(M1)]
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).	Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-TT Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
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).	Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-TT Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).	Prior to (PRE) and one month post vaccination [PI(M1)]
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE) and one month after vaccination [PI(M1)]
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.	Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE) and one month post vaccination [PI(M1)]
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.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
rSBA Antibody Titers	Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
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.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
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).	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
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.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in μg/mL.	Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
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.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
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.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
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.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Anti-PS Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	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)]
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.	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)]
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.	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)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	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)]
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.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	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)]
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.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.	At Persistence Year 4 [PI(M48)]
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.	At Persistence Year 4 [PI(M48)]
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.	At Persistence Year 4 [PI(M48)]
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.	At Persistence Year 4 [PI(M48)]
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.	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)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	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)]
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.	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)]
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.	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)]
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.	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)]
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.	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)]
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.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.	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)]
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.	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)]
rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.	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)]
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.	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)]
hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	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)]
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.	During the 4-day (Day 0-3) follow-up period
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.	During the 4-day (Day 0-3) follow-up period
Number of Subjects With Rash	Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.	From administration of the vaccine dose until 6 months later
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.	From administration of the vaccine dose until 6 months later
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.	From administration of the vaccine dose until 6 months later
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.	During the 31-day (Days 0-30) post-vaccination period
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.	Up to 6 Months after vaccination
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.	From 6 Months after vaccination up to Year 1
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.	From 6 Months after vaccination up to Year 2
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.	From 6 Months following vaccination up to Year 3
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.	From 6 Months following vaccination up to Year 4
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.	From 6 Months following vaccination up to Year 5

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2007
• Primary Completion (Actual): December 3, 2007
• Study Completion (Actual): December 3, 2007

Study Registration Dates

• First Submitted: January 26, 2007
• First Submitted That Met QC Criteria: January 26, 2007
• First Posted (Estimate): January 29, 2007

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Immunogenicity; Conjugate vaccine; Persistence; Meningococcal vaccine; Meningococcal serogroups A, C, W-135 and/or Y diseases; Non-inferiority
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections
• Other Study ID Numbers: 108658; 108660 (Y1) (Other Identifier: GSK); 108661 (Y2) (Other Identifier: GSK); 108663 (Y3) (Other Identifier: GSK); 108665 (Y4) (Other Identifier: GSK); 108668 (Y5) (Other Identifier: GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 108658
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Individual Participant Data Set
   Information identifier: 108658
   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