Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months old Toddlers.
Trial overview
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-Men-Y) antibody titers greater than or equal to the cut-off value
Timeframe: One month after the last dose (at Month 4)
Number of subjects with serum bactericidal assay using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers greater than or equal to the cut-off value
Timeframe: One month after the first dose (at Month 1)
Number of subjects with serum bactericidal assay using hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers greater than or equal to the cut-off value
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y antibody titers
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
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) antibody titers greater than or equal to the cut-off value
Timeframe: At Month 1 (for GSK 134612 2 doses Group only) and Month 4
Number of subjects with serum bactericidal assay using rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers greater than or equal to the cut-off value
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y antibody titers
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4
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
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of subjects with anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations greater than or equal to the cut-off value
Timeframe: At Month 1 (GSK 134612 s doses Group only) and Month 4
Anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations
Timeframe: At Month 1 (GSK 134612 2 doses Group only) and Month 4
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Days 0-3) and 8-day (Days 0-7) periods following each vaccination
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Up to 1 month post-vaccination
Number of subjects with serious adverse events (SAEs)
Timeframe: Up to study end (Month 9)
Number of subjects with new onset chronic ilnesses (NOCI)
Timeframe: Up to study end (Month 9)
Number of subjects reporting rash
Timeframe: Up to study end (Month 9)
Number of subjects reporting Adverse Events resulting in Emergency Room (ER) visits
Timeframe: Up to study end (Month 9)
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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.
•Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol •A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment. •Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site. •Written informed consent obtained from parents/guardian of the subject. •Healthy subjects as established by medical history and clinical examination before entering into the study.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, 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 1 month of a dose of study vaccine(s), with the exception of influenza vaccine. •Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination). •Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y. •History of meningococcal diseases. •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required). •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. •History of reactions or allergic disease 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 enrollment. •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.