Phase 3
Completed N=295
Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612
Infections, Meningococcal
Source: ClinicalTrials.gov NCT00955682 ↗
Enrolled (actual)
295
Serious AEs
0.7%
Results posted
Aug 2019
Primary outcomePrimary: Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off — 177; 23; 164; 20 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serum Bactericidal Assay /Activity (rSBA) Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Baby Rabbit Complement) Titres ≥ the Cut-off |
177; 23; 164; 20; 186; 17 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
60; 3; 23; 3; 87; 2 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
60; 3; 23; 3; 87; 2 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres |
166; 13; 91; 16; 111; 7 | — |
| PRIMARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres |
166; 13; 91; 16; 111; 7 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBAMenY Titres ≥ the Cut-off |
166; 16; 90; 14; 171; 12 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
60; 3; 23; 3; 87; 2 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
60; 3; 23; 3; 87; 2 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBAMenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
60; 3; 23; 3; 87; 2 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
214; 9; 214; 8; 215; 43 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off |
58; 4; 57; 4; 154; 15 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off |
58; 4; 57; 4; 154; 15 | — |
| SECONDARY Number of Subjects With Serum Bactericidal Assay/Activity Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (Using Human Complement) Titres ≥ the Cut-off |
58; 4; 57; 4; 154; 15 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres |
88; 2.5; 1342.3; 931.1; 2196.6; 3.4 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres |
88; 2.5; 1342.3; 931.1; 2196.6; 3.4 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres |
88; 2.5; 1342.3; 931.1; 2196.6; 3.4 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
53; 20; 26; 9; 16; 7 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
53; 20; 26; 9; 16; 7 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
53; 20; 26; 9; 16; 7 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
4.22; 1.41; 1.81; 2.93; 9.44; 0.26 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
4.22; 1.41; 1.81; 2.93; 9.44; 0.26 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
4.22; 1.41; 1.81; 2.93; 9.44; 0.26 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
53; 20; 26; 9; 16; 7 | — |
| SECONDARY Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
53; 20; 26; 9; 16; 7 | — |
| SECONDARY Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
2.05; 1.65; 0.25; 0.31; 0.85; 0.35 | — |
| SECONDARY Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
2.05; 1.65; 0.25; 0.31; 0.85; 0.35 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres ≥ the Cut-off |
214; 9; 214; 8; 215; 43 | — |
| SECONDARY Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres Above the Cut-off Values |
231; 3; 229; 3; 225; 45 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titres |
978.9; 5.4; 226.4; 320.9; 1390.7; 4.7 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values |
211; 3; 211; 3; 228; 33 | — |
| SECONDARY Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres Above the Cut-off Values |
211; 3; 211; 3; 228; 33 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres |
88; 2.5; 1342.3; 931.1; 2196.6; 3.4 | — |
| SECONDARY hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Titres |
88; 2.5; 1342.3; 931.1; 2196.6; 3.4 | — |
| SECONDARY Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Above the Cut-off Values |
67; 15; 66; 6; 70; 18 | — |
| SECONDARY Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY ≥ the Cut-off Values |
98; 22; 82; 5; 85; 13 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
4.22; 1.41; 1.81; 2.93; 9.44; 0.26 | — |
| SECONDARY Anti-PSA, Anti-PSC, Anti-PSW, and Anti-PSY Antibody Concentrations |
4.22; 1.41; 1.81; 2.93; 9.44; 0.26 | — |
| SECONDARY Number of Subjects Reporting Any Solicited Local Symptoms |
149; 23; 90; 17; 70; 11 | — |
| SECONDARY Number of Subjects Reporting Any Solicited General Symptoms |
41; 10; 40; 11; 31; 8 | — |
| SECONDARY Number of Subjects Reporting Any Adverse Events (AEs) |
106; 18 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects Reporting Any Serious Adverse Events (SAEs) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- A male or female having completed the primary study 109670 and who was primed with the investigational or Meningitec™ vaccines.
Exclusion Criteria
Exclusion criteria for persistence study entry (i.e. Month 24, 36 or 48):
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the subject's first visit.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of study 109670.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Administration of immunoglobulins and/or blood products within the three months preceding the subjects first visit.
- Concurrently participating in another clinical study, within 30 days of study entry, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
Additional exclusion criteria for booster vaccination (to be checked at Month 48):
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein and/or tetanus toxoid.
- History of hypersensitivity after previous administration of Meningitec or the investigational vaccines in study 109670.
- Hypersensitivity to latex.
- Planned administration/ administration of a vaccine not foreseen by the protocol within one month before and 30 days after the booster dose.
- Previous vaccination with any component of the vaccines within the last month.
- History of any neurological disorder or seizures (one episode of febrile convulsion does not constitute an exclusion criteria).
- Major congenital defects or serious chronic illness.
- Acute disease at the time of vaccination.
Data sourced from ClinicalTrials.gov (NCT00955682). 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.