Immunogenicity & Safety of GSK's Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age

Condition(s) targeted: Invasive Disease Caused by Neisseria Meningitidis Due to Serogroups A, C, W-135, Y

Intervention: GSK vaccine 134612 (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

The purpose of the study is to characterize the immunogenicity & safety study of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age (co-administered with PedvaxHIB®) or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlers. This study is single-blinded for the primary phase and open-label for the booster phase.

Official title: Immunogenicity & Safety Study of a Booster Dose of GSK's Meningococcal Vaccine 134612 Given at 12-15 Months of Age (co-Administered With PedvaxHIB®) or at 15-18 Months of Age (co-Administered With Infanrix®) in Primed Healthy Toddlers

Study design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

hSBA-MenC, and hSBA-MenY GMTs

hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off

Anti-PRP antibody concentrations >=1.0 µg/mL

Anti-D concentrations >=1.0 IU/mL

Anti-T concentrations >=1.0 IU/mL

Anti-PT, anti-FHA and anti-PRN GMCs

hSBA-MenC, and hSBA-MenY GMTs

hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off

Secondary outcome:

Anti-PRP GMCs and antibody concentrations >=0.15 µg/mL

rSBA-MenC and rSBA-MenY GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects

Anti-PSC and anti-PSY antibody GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects

hSBA-MenC and hSBA-MenY antibody titers above protocol-specified cut-offs

hSBA-MenA and hSBA MenW-135 GMTs and antibody titers above protocol-specified cut-off

rSBA-MenA and rSBA-MenW-135 GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects

Anti-PSA and anti-PSW-135 antibody GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects

hSBA-MenC, and hSBA-MenY GMTs

hSBA-MenC and MenY titers above protocol-specified cut-offs

Anti-D and anti-T GMCs

Anti-PT, anti-FHA and anti-PRN concentrations >=5 ELISA Units (EL.U)/mL

Anti-D and anti-T seroprotection rates (antibody concentrations >=0.1 IU/mL)

hSBA- MenA, hSBA-MenW-135 GMTs

hSBA-MenC and hSBA-MenY titers above protocol-specified cut-off

rSBA- MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects

Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY GMCs and antibody concentrations >=0.3 µg/mL and >=2.0 µg/mL in a subset of 30% of subjects

Occurrence of solicited local and general symptoms

Occurrence of unsolicited symptoms

Occurrence of serious adverse events (SAEs) and/or the specific AEs of: - new onset of chronic illness(es), - conditions prompting ER visits

Occurrence of SAEs and/or the specific AEs of: - new onset of chronic illness(es), - rash and/or - conditions prompting emergency room (ER) visits

Minimum age: 6 Weeks. Maximum age: 12 Weeks. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects for whom the investigator believes that parents/guardians can and will comply

with the requirements of the protocol .

- A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time

of the first vaccination.

- Written informed consent obtained from the parent or guardian of the subject.

- Healthy subjects as established by medical history and clinical examination before

entering into the study.

- Born after 36 weeks gestation.

- For inclusion in the booster phase, subjects must have received all three doses in the

primary phase.

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 of immunosuppressants or other immune-modifying drugs since

birth.

- Planned administration/ administration of a vaccine not foreseen by the study protocol

within 30 days of the first dose of study vaccine(s).

- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b,

diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.

- History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b,

diphtheria, tetanus, polio or pertussis diseases.

- Any confirmed or suspected immunosuppressive or immunodeficient condition based on

medical history and physical examination.

- History of allergic disease or reactions likely to be exacerbated by any component of

the vaccines, or by dry natural latex rubber.

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures.

- Acute disease at time of enrollment.

- Administration of immunoglobulins and/or any blood products since birth or planned

administration during the study period.

- Concurrent participation in another clinical study, at any time during the study

period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

GSK Clinical Trials Call Center, Dothan, Alabama 36305, United States; Active, not recruiting

GSK Clinical Trials Call Center, Jonesboro, Arkansas 72401, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Benton, Arkansas 72019, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Little Rock, Arkansas 72205, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fayetteville, Arkansas 72703, United States; Active, not recruiting

GSK Clinical Trials Call Center, West Covina, California 91790, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fresno, California 93726, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Fountain Valley, California 92708, United States; Active, not recruiting

GSK Clinical Trials Call Center, Woodstock, Georgia 30189, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Marietta, Georgia 30062, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Nampa, Idaho 2084633126, United States; Active, not recruiting

GSK Clinical Trials Call Center, Arkansas City, Kansas 67005, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Lexington, Kentucky 40503, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Bossier City, Louisiana 71111, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Boston, Massachusetts 2130, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Portage, Michigan 49024, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Kalamazoo, Michigan 49008, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Stevensville, Michigan 49127, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Nies, Michigan 49120, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Richland, Michigan 49083, United States; Active, not recruiting

GSK Clinical Trials Call Center, St Paul, Minnesota 55108, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Clyde, North Carolina 28721, United States; Active, not recruiting

GSK Clinical Trials Call Center, Raleigh, North Carolina 27609, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cleveland, Ohio 44121, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Huber Heights, Ohio 4544, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Gresham, Oregon 97030, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Uniontown, Pennsylvania 15401, United States; Active, not recruiting

GSK Clinical Trials Call Center, Erie, Pennsylvania 16505, United States; Active, not recruiting

GSK Clinical Trials Call Center, Greenville, Pennsylvania 16125, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15241, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15220, United States; Active, not recruiting

GSK Clinical Trials Call Center, Pittsburgh, Pennsylvania 15236, United States; Active, not recruiting

GSK Clinical Trials Call Center, Charleston, South Carolina 29406, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Kingsport, Tennessee 37660, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinial Trials Call Center, Sugar Land, Texas 77479, United States; Recruiting
GSK Clinial Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Amarillo, Texas 79124, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Galveston, Texas 77555-1119, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Roy, Utah 84067, United States; Active, not recruiting

GSK Clinical Trials Call Center, Layton, Utah 84041, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, South Jordan, Utah 84095, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Orem, Utah 84057, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, South Jordan, Utah 84095, United States; Active, not recruiting

GSK Clinical Trials Call Center, Provo, Utah 84604, United States; Recruiting
GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Clinical Trials Call Center, Layton, Utah 84041, United States; Active, not recruiting

GSK Clinical Trials Call Center, St. George, Utah 84790, United States; Active, not recruiting

GSK Clinical Trials Call Center, Ogden, Utah 84405, United States; Active, not recruiting

Starting date: February 2008
Last updated: April 10, 2008