Phase 2
Completed N=613
Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00427908 ↗
Enrolled (actual)
613
Serious AEs
2.5%
Results posted
Jun 2018
Primary outcomePrimary: 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 — 182; 57; 200; 56 Participants
Summary
This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.
Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
182; 57; 200; 56; 199; 65 | — |
| PRIMARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| PRIMARY Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
100; 34.9; 100; 98.5; 100; 42.9 | — |
| PRIMARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| PRIMARY Percentage of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
100; 34.9; 100; 98.5; 100; 42.9 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Values |
124; 40; 96; 32; 225; 75 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY 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 |
10; 4; 2; 1; 162; 2 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value |
7; 4; 143; 2; 109; 2 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value |
18; 5; 30; 4 | — |
| SECONDARY Anti-TT Antibody Concentrations |
1.541; 2.103; 20.951; 1.74 | — |
| SECONDARY Number of Subjects With Anti-TT Antibody Concentrations |
19; 4; 32; 7 | — |
| SECONDARY Anti-TT Antibody Concentrations |
1.541; 2.103; 20.951; 1.74 | — |
| SECONDARY 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 |
3; 3; 203; 4; 3; 1 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers ≥ the Cut-off Value |
2; 2; 91; 9; 35; 9 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value |
7; 4; 143; 2; 109; 2 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value |
24; 11; 208; 58; 201; 54 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
0; 0; 48; 0; 12; 0 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers ≥ to the Cut-off Value |
2; 2; 85; 9; 19; 4 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value |
7; 4; 143; 2; 109; 2 | — |
| SECONDARY Number of Subjects With Anti-PS Antibody Concentrations ≥ the Cut-off Value |
24; 11; 208; 58; 201; 54 | — |
| SECONDARY Anti-PS Antibody Concentrations |
0.18; 0.21; 34.76; 11.2; 2.27; 4.62 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
0; 0; 48; 0; 12; 0 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
0; 0; 48; 0; 12; 0 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers (HPA Laboratory Assay) |
77.5; 7.3; 21.7; 23.5; 671.1; 7.6 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
0; 0; 48; 0; 12; 0 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
29; 0; 36; 0; 44; 8 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value |
86; 1; 89; 2; 96; 12 | — |
| SECONDARY rSBA Antibody Titers |
123.5; 5; 141.3; 4.7; 118.3; 206.8 | — |
| SECONDARY Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value |
0; 0; 48; 0; 12; 0 | — |
| SECONDARY hSBA Antibody Titers |
2; 2; 78.5; 2; 4.1; 2 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
76; 51; 84; 20; 39; 39 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
63; 30; 45; 25; 5; 8 | — |
| SECONDARY Number of Subjects With Rash |
10; 6; 9; 1 | — |
| SECONDARY Number of Subjects With New Onset of Chronic Illnesses (NOCIs) |
1; 0; 2; 4 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit |
21; 8; 15; 5 | — |
| SECONDARY Number of Subjects With Unsolicited AEs |
121; 38; 83; 24 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5; 7; 2; 1 | — |
| SECONDARY Number of Subjects With SAE(s) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With SAE(s) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With SAE(s) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With SAE(s) |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With SAE(s) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.
- A male or female between, and including, 1 through 10 years of age at the time of vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.
Exclusion Criteria
For the primary phase:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).
- Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).
- Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.
- Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.
- History of meningococcal disease due to serogroup A, C, W, or Y.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
For the long term persistence phase:
- History of meningococcal serogroup A, C, W, and/or Y disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Data sourced from ClinicalTrials.gov (NCT00427908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.