Mode
Text Size
Log in / Sign up
Phase 2 Completed N=349 Randomized Prevention

Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

Infections, Meningococcal
Source: ClinicalTrials.gov NCT00471081 ↗
Enrolled (actual)
349
Serious AEs
2.0%
Results posted
Sep 2018
Primary outcomePrimary: 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 — 105; 122; 123; 137 Participants

Summary

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

Outcome Measures

OutcomeResultp-value
PRIMARY
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
105; 122; 123; 137; 60; 142
SECONDARY
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
90; 115; 122; 115; 123; 137
SECONDARY
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
90; 115; 122; 115; 123; 137
SECONDARY
hSBA-MenA, hSBA-MenC, hSBA-MenW -135 and hSBA-Men-Y Antibody Titers
13.6; 24.9; 50.8; 83.7; 161.5; 1105.5
SECONDARY
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
41; 51; 47; 42; 51; 51
SECONDARY
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
41; 50; 47; 35; 44; 50
SECONDARY
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
1092.6; 1911.5; 1179.1; 229.3; 456.3; 1484.4
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
35; 26; 29; 66; 60; 56
SECONDARY
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
35; 26; 27; 65; 59; 40
SECONDARY
Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
12.39; 35.92; 5.59; 8.15; 10.91; 3.42
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
34; 54; 0; 0; 28; 49
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
42; 63; 1; 0; 32; 51
SECONDARY
Number of Subjects With Any Unsolicited Adverse Events (AEs)
87; 140
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
5; 2
SECONDARY
Number of Subjects With New Onset Chronic Ilnesses (NOCI)
19; 38
SECONDARY
Number of Subjects Reporting Rash
16; 61
SECONDARY
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
17; 32

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00471081). 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.

Back to search