Infections, MeningococcalPhase 2NCT00427908

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

A Phase 2 study testing GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY and Meningitec™ in people with Infections, Meningococcal, run by GlaxoSmithKline at 11 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 year to 10 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY and Meningitec™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 613 participants
Where: 11 sitesFinland
Study dates: 7 Feb 2007to 3 Dec 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Finland11 sites

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

Other trials in Finland

About this study

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)

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.

Read the 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.

Conditions: Infections, Meningococcal
Being tested: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix), Mencevax™ ACWY, Meningitec™
Keywords: Meningococcal serogroups A, C, W-135 and/or Y diseases, Conjugate vaccine, Immunogenicity, Meningococcal vaccine, Persistence, Non-inferiority
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)Biological
One intramuscular dose.
Mencevax™ ACWYBiological
One subcutaneous dose.
Meningitec™Biological
One intramuscular dose.

Study groups in NCT00427908
Study group	Role	What they receive
Group A	Experimental	All subjects received GSK Biolgicals' meningococcal vaccine 134612. Receives: Biological: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
Group B	Active comparator	Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™. Receives: Biological: Mencevax™ ACWY; Biological: Meningitec™

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One month after vaccination [PI(M1)]

Secondary outcomes (76)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-PS Antibody Concentrations
Antibody concentrations were presented as micrograms per milliliter (μg/mL).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Measured: 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.
Measured: Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: During the 4-day (Day 0-3) follow-up period
Number of Subjects With Rash
Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 6 Months following vaccination up to Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Feb 20073 Dec 2007

First posted29 Jan 2007 (estimated)
Study start7 Feb 2007
Primary completion3 Dec 2007
Study completion3 Dec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00427908
Sponsor's protocol ID: 108658
Other IDs: 108660 (Y1), 108661 (Y2), 108663 (Y3), 108665 (Y4), 108668 (Y5)
Status last verified: May 2018
First submitted: 26 Jan 2007
Last updated: 4 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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.
PubMed 23032168
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.
PubMed 23032159

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT00427908
Acronym / sponsor ID: 108658
Conditions: Infections, Meningococcal
Keywords: Meningococcal serogroups A, C, W-135 and/or Y diseases, Conjugate vaccine, Immunogenicity, Meningococcal vaccine, Persistence, Non-inferiority
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 613 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 7 Feb 2007 (actual)
Primary completion: 3 Dec 2007 (actual)
Study completion: 3 Dec 2007 (actual)
First posted: 29 Jan 2007 (estimated)
Results: Posted 4 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Biological: GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)All subjects received GSK Biolgicals' meningococcal vaccine 134612.
Group B	Active comparator	Biological: Mencevax™ ACWY, Biological: Meningitec™Subjects including and above two years of age received Mencevax™ ACWY, subjects below two years of age received Meningitec™.

Who may qualify

Ages: 1 year to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)One intramuscular dose.	Biological	Group A
Mencevax™ ACWYOne subcutaneous dose.	Biological	Group B
Meningitec™One intramuscular dose.	Biological	Group B

Primary outcome

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.
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.
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.
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.
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.

76 secondary outcomes

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)]
rSBA Antibody Titers
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
rSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-PS Antibody Concentrations
Time frame: 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
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-PS Antibody Concentrations
Time frame: 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
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-TT Antibody Concentrations
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Number of Subjects With Anti-TT Antibody Concentrations
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Anti-TT Antibody Concentrations
Time frame: 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
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value
Time frame: Prior to (PRE) and one month after vaccination [PI(M1)]
hSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
rSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
rSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Anti-PS Antibody Concentrations
Time frame: 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
Time frame: Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Anti-PS Antibody Concentrations
Time frame: 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
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
hSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
hSBA Antibody Titers
Time frame: 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
Time frame: Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]
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)]

Results and safety

Results posted to the registry on 4 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimenrix 1-2 Years of Age Group	229	224
Nimenrix 2-11 Years of Age Group	231	228
Meningitec 1-2 Years of Age Group	75	72
Mencevax 2-11 Years of Age Group	78	78

Primary outcome: 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. Count of participants. Unit: Participants

Measure	Nimenrix 2-11 Years of Age Primary Phase Group n = 219	Mencevax 2-11 Years of Age Primary Phase Group n = 70
rSBA-MenA	182	57
rSBA-MenC	200	56
rSBA-MenW-135	199	65
rSBA-MenY	217	58

Nimenrix 2-11 Years of Age Primary Phase Group vs Mencevax 2-11 Years of Age Primary Phase Group: Difference in percentage: 6.44 (95% CI 1.15 to 16.04)
Nimenrix 2-11 Years of Age Primary Phase Group vs Mencevax 2-11 Years of Age Primary Phase Group: Difference in percentage: 13.18 (95% CI 4.79 to 24.32)
Nimenrix 2-11 Years of Age Primary Phase Group vs Mencevax 2-11 Years of Age Primary Phase Group: Difference in percentage: 4.41 (95% CI 1.51 to 12.21)

Population analysed: The analysis was performed on subjects of 2 years and above from the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Primary outcome: Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

Time frame: Prior to (PRE) vaccination. Count of participants. Unit: Participants

Measure	Nimenrix 1-2 Years of Age Group n = 208	Meningitec 1-2 Years of Age Group n = 67
rSBA-MenA	81	26
rSBA-MenC	80	19
rSBA-MenW-135	59	24
rSBA-MenY	115	41

Population analysed: The analysis was performed on subjects from 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Primary outcome: Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

Time frame: Prior to (PRE) to vaccination. Number (95% Confidence Interval). Unit: Percentage

Measure	Nimenrix 1-2 Years of Age Group n = 208	Meningitec 1-2 Years of Age Group n = 67
rSBA-MenA	42.4 (35.3 to 49.8)	40.0 (28.0 to 52.9)
rSBA-MenC	39.4 (32.6 to 46.5)	31.1 (19.9 to 44.3)
rSBA-MenW-135	28.4 (22.3 to 35)	38.7 (26.6 to 51.9)
rSBA-MenY	55.3 (48.3 to 62.2)	61.2 (48.5 to 72.9)

Population analysed: The analysis was performed on subjects of 1 to 2 years of age from the ATP cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination.

Primary outcome: Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value

Time frame: One month after vaccination [PI(M1)]. Count of participants. Unit: Participants

Measure	Nimenrix 1-2 Years of Age Group n = 222	Meningitec 1-2 Years of Age Group n = 68
rSBA-MenA	222	22
rSBA-MenC	220	67
rSBA-MenW-135	222	27
rSBA-MenY	222	49

Nimenrix 1-2 Years of Age Group vs Meningitec 1-2 Years of Age Group: Difference in vaccine response rate: 1.47 (95% CI -0.27 to 7.89)

76 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: during the 4-day (Day 0-3) follow-up vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 60).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix 1-2 Years of Age Group	5 of 229 (2.2%)	193 of 229 (84.3%)	0 of 229
Nimenrix 2-11 Years of Age Group	2 of 231 (0.9%)	192 of 231 (83.1%)	0 of 231
Meningitec 1-2 Years of Age Group	7 of 75 (9.3%)	64 of 75 (85.3%)	0 of 75
Mencevax 2-11 Years of Age Group	1 of 78 (1.3%)	67 of 78 (85.9%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23032168Vesikari 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.
Background: PubMed 23032159Vesikari 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Infections, Meningococcal

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00427908, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.