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OpenTrials
Completed

NCT Number: NCT00427908

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

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.

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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Espoo, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)

Biological

One intramuscular dose.

Mencevax™ ACWY

Biological

One subcutaneous dose.

Meningitec™

Biological

One intramuscular dose.

Primary outcomes

  1. 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

    Time frame: One Month after vaccination

    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.

  2. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE) vaccination

    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.

  3. Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE) to vaccination

    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.

  4. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: One month after vaccination [PI(M1)]

    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.

  5. Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: One month after vaccination [PI(M1)]

    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 outcomes

  1. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    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.

  2. rSBA Antibody Titers

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  3. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    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.

  4. rSBA Antibody Titers

    Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  5. 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

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    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.

  6. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

  7. Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    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.

  8. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]

    Antibody concentrations were presented as micrograms per milliliter (μg/mL).

  9. Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  10. Anti-TT Antibody Concentrations

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

  11. Number of Subjects With Anti-TT Antibody Concentrations

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

  12. Anti-TT Antibody Concentrations

    Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]

    Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).

  13. 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

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  14. hSBA Antibody Titers

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    Antibody titers are presented as geometric mean titers (GMTs).

  15. Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value

    Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  16. hSBA Antibody Titers

    Time frame: Prior to (PRE) and one month post vaccination [PI(M1)]

    Antibody titers are presented as geometric mean titers (GMTs).

  17. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    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.

  18. rSBA Antibody Titers

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.

  19. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    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.

  20. rSBA Antibody Titers

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.

  21. Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).

  22. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

  23. Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 μg/mL.

  24. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

    Antibody concentrations are presented as GMCs and expressed in μg/mL.

  25. Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  26. hSBA Antibody Titers

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    Antibody titers are presented as geometric mean titers (GMTs).

  27. Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]

    The cut-off value for the hSBA titers was greater or equal to (≥) 1:4.

  28. hSBA Antibody Titers

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]

    Antibody titers are presented as geometric mean titers (GMTs).

  29. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    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.

  30. rSBA Antibody Titers

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  31. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    The cut-off value for the rSBA titers was ≥ 1:8. This analysis was performed by the GSK Biologicals' laboratory.

  32. rSBA Antibody Titers

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  33. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).

  34. Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

  35. Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value

    Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    The cut-off value for the anti-polysaccharide concentrations was ≥ 0.3 micrograms per milliliter (μg/mL).

  36. Anti-PS Antibody Concentrations

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (μg/mL).

  37. Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  38. hSBA Antibody Titers

    Time frame: Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]

    Antibody titers are presented as geometric mean titers (GMTs).

  39. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    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.

  40. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.

  41. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  42. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    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)]

    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.

  43. Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  44. hSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs).

  45. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    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.

  46. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  47. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    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)]

    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.

  48. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.

  49. rSBA Antibody Titers

    Time frame: At Persistence Year 4 [PI(M48)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

  50. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    Time frame: At Persistence Year 4 [PI(M48)]

    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.

  51. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    Time frame: At Persistence Year 4 [PI(M48)]

    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.

  52. rSBA Antibody Titers (HPA Laboratory Assay)

    Time frame: At Persistence Year 4 [PI(M48)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

  53. Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  54. hSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs).

  55. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    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.

  56. rSBA Antibody Titers

    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)]

    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.

  57. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    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)]

    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.

  58. rSBA Antibody Titers

    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)]

    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.

  59. Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    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.

  60. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.

  61. Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value

    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)]

    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.

  62. rSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.

  63. Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value

    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)]

    The cut-off value for the hSBA titers was greater than or equal to (≥) 1:4.

  64. hSBA Antibody Titers

    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)]

    Antibody titers are presented as geometric mean titers (GMTs).

  65. Number of Subjects With Solicited Local Symptoms

    Time frame: During the 4-day (Day 0-3) follow-up period

    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.

  66. Number of Subjects With Solicited General Symptoms

    Time frame: During the 4-day (Day 0-3) follow-up period

    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.

  67. Number of Subjects With Rash

    Time frame: From administration of the vaccine dose until 6 months later

    Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.

  68. Number of Subjects With New Onset of Chronic Illnesses (NOCIs)

    Time frame: From administration of the vaccine dose until 6 months later

    NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

  69. Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit

    Time frame: From administration of the vaccine dose until 6 months later

    Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.

  70. Number of Subjects With Unsolicited AEs

    Time frame: During the 31-day (Days 0-30) post-vaccination period

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  71. Number of Subjects With Serious Adverse Events (SAEs)

    Time frame: Up to 6 Months after vaccination

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  72. Number of Subjects With SAE(s)

    Time frame: From 6 Months after vaccination up to Year 1

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  73. Number of Subjects With SAE(s)

    Time frame: From 6 Months after vaccination up to Year 2

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  74. Number of Subjects With SAE(s)

    Time frame: From 6 Months following vaccination up to Year 3

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  75. Number of Subjects With SAE(s)

    Time frame: From 6 Months following vaccination up to Year 4

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  76. Number of Subjects With SAE(s)

    Time frame: From 6 Months following vaccination up to Year 5

    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 29, 2007
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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