Back to resultsSafety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Conjugated meningococcal ACWY-TT (vaccine)
DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
Meningitec™
Mencevax™ACWY
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Safety, Meningococcal vaccine, Dose selection, Toddlers, Immunogenicity, Conjugate vaccine, Reactogenicity, Children
Eligibility Criteria
Inclusion criteria: Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first 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. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine. Exclusion criteria: Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose. Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV). Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease. Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine. For subjects aged 12-14 months at enrolment: For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. History of meningococcal serogroup A, C, W-135 or Y disease. Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year. 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
GSK134612A Form1 (T), Primary Group
GSK134612A Form2 (T), Primary Group
GSK134612A Form3 (T), Primary Group
GSK134612A Form4 (T), Primary Group
Control (T), Primary Group
GSK134612A Form1 (C), Primary Group
GSK134612A Form2 (C), Primary Group
GSK134612A Form3 (C), Primary Group
GSK134612A Form4 (C), Primary Group
Control (C), Primary Group
GSK134612A Form1 (T), Booster Group
Control (T), Booster Group
GSK134612A Form1 (C), Booster Group
Control (C), Booster Group
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Outcomes
Primary Outcome Measures
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
Secondary Outcome Measures
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against Tetanus (Anti-T)
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Number of Toddlers With Any Solicited Local Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Children With Any Solicited Local Symptoms
The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Toddlers With Any Solicited General Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Number of Children With Any Solicited General Symptoms
The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any 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 = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
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.
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
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.
Number of Subjects With Any 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.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of Subjects With SAEs
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00196976
Brief Title
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
Official Title
Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 24, 2005 (undefined)
Primary Completion Date
March 1, 2006 (Actual)
Study Completion Date
March 3, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Safety, Meningococcal vaccine, Dose selection, Toddlers, Immunogenicity, Conjugate vaccine, Reactogenicity, Children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
461 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK134612A Form1 (T), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Arm Title
GSK134612A Form2 (T), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Arm Title
GSK134612A Form3 (T), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Arm Title
GSK134612A Form4 (T), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Arm Title
Control (T), Primary Group
Arm Type
Active Comparator
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination.
Arm Title
GSK134612A Form1 (C), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Arm Title
GSK134612A Form2 (C), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Arm Title
GSK134612A Form3 (C), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Arm Title
GSK134612A Form4 (C), Primary Group
Arm Type
Experimental
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533).
Arm Title
Control (C), Primary Group
Arm Type
Active Comparator
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533).
Arm Title
GSK134612A Form1 (T), Booster Group
Arm Type
Experimental
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
Arm Title
Control (T), Booster Group
Arm Type
Active Comparator
Arm Description
Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534).
Arm Title
GSK134612A Form1 (C), Booster Group
Arm Type
Experimental
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination.
Arm Title
Control (C), Booster Group
Arm Type
Active Comparator
Arm Description
Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination.
Intervention Type
Biological
Intervention Name(s)
Conjugated meningococcal ACWY-TT (vaccine)
Intervention Description
One intramuscular dose during the primary vaccination
Intervention Type
Biological
Intervention Name(s)
DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)
Intervention Description
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
Intervention Type
Biological
Intervention Name(s)
DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
Intervention Description
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
Intervention Type
Biological
Intervention Name(s)
Meningitec™
Intervention Description
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
Intervention Type
Biological
Intervention Name(s)
Mencevax™ACWY
Intervention Description
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
Primary Outcome Measure Information:
Title
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
Description
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
Time Frame
One month after the first vaccine dose (Month 1)
Secondary Outcome Measure Information:
Title
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Description
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Description
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time Frame
Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Title
Antibody Titers Against Different Meningococcal Serogroups
Description
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Description
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Description
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Antibody Concentrations Against Different Meningococcal Polysaccharides
Description
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
Description
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Antibody Concentrations Against Tetanus (Anti-T)
Description
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time Frame
Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Title
Number of Toddlers With Any Solicited Local Symptoms
Description
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Title
Number of Children With Any Solicited Local Symptoms
Description
The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Title
Number of Toddlers With Any Solicited General Symptoms
Description
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time Frame
During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Title
Number of Children With Any Solicited General Symptoms
Description
The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time Frame
During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Title
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Description
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Time Frame
At one month (M1) and 12 months (M12) post-primary vaccination
Title
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Description
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Time Frame
At one month (M1) and 12 months (M12) post-primary vaccination
Title
Antibody Titers Against Different Meningococcal Serogroups
Description
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time Frame
At one month (M1) and 12 months (M12) post-primary vaccination
Title
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Description
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
At one month (M1) and 12 months (M12) post-primary vaccination
Title
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Description
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Time Frame
At one month (M1) and 12 months (M12) post primary vaccination
Title
Antibody Concentrations Against Different Meningococcal Polysaccharides
Description
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
At one month (M1) and 12 months (M12) post-primary vaccination
Title
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
Description
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
Time Frame
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Title
Antibody Titers Against Different Meningococcal Serogroups
Description
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Time Frame
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Title
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
Description
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
Time Frame
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Title
Antibody Concentrations Against Different Meningococcal Polysaccharides
Description
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time Frame
Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Title
Number of Subjects With Any Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame
During the 8-day (Days 0-7) post-vaccination period following booster dose
Title
Number of Subjects With Any Solicited General Symptoms
Description
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 = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Time Frame
During the 8-day (Days 0-7) post-vaccination period following booster dose
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
Description
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.
Time Frame
Within 31 days (Days 0-30) after the primary meningococcal vaccination
Title
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
Description
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.
Time Frame
Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Title
Number of Subjects With Any Unsolicited AEs
Description
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.
Time Frame
Within 31 days (Days 0-30) after the booster vaccination
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the primary vaccination study (from Month 0 up to Month 2)
Title
Number of Subjects With SAEs
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first 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. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Exclusion criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first 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 first vaccine dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
For subjects aged 12-14 months at enrolment:
For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
History of meningococcal serogroup A, C, W-135 or Y disease.
Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Eferding
ZIP/Postal Code
A-4070
Country
Austria
Facility Name
GSK Investigational Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1020
Country
Austria
Facility Name
GSK Investigational Site
City
Villach
ZIP/Postal Code
A-9500
Country
Austria
Facility Name
GSK Investigational Site
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
GSK Investigational Site
City
Heraklion, Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
GSK Investigational Site
City
Ioannina
ZIP/Postal Code
452 21
Country
Greece
Facility Name
GSK Investigational Site
City
Komotini
ZIP/Postal Code
69100
Country
Greece
Facility Name
GSK Investigational Site
City
Koufalia
ZIP/Postal Code
571 00
Country
Greece
Facility Name
GSK Investigational Site
City
Markopoulo
ZIP/Postal Code
19003
Country
Greece
Facility Name
GSK Investigational Site
City
N. Efkarpia, Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
GSK Investigational Site
City
Nea Makri
ZIP/Postal Code
19005
Country
Greece
Facility Name
GSK Investigational Site
City
Rio/Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
GSK Investigational Site
City
Tripolis
ZIP/Postal Code
22100
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103533 are summarised with study 103534 on the GSK Clinical Study Register.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
103533
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
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