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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00614614

Purpose

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.

Condition	Intervention	Phase
Invasive Neisseria Meningitidis Serogroup Diseases	Biological: GSK vaccine 134612	Phase III

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: One month after vaccination at 12-15 months of age ]
hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 12-15 months of age ]
Anti-PRP antibody concentrations >=1.0 µg/mL [ Time Frame: One month after vaccination at 12-15 months of age ]
Anti-D concentrations >=1.0 IU/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
Anti-T concentrations >=1.0 IU/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
Anti-PT, anti-FHA and anti-PRN GMCs [ Time Frame: One month after vaccination at 15-18 months of age ]
hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: One month after vaccination at 15-18 months of age ]
hSBA-MenA, hSBA-MenW-135 titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 15-18 months of age ]

Secondary Outcome Measures:

Anti-PRP GMCs and antibody concentrations >=0.15 µg/mL [ Time Frame: One month after vaccination at 12-15 months of age ]
rSBA-MenC and rSBA-MenY GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
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 [ Time Frame: One month after vaccination at 12-15 months of age ]
hSBA-MenC and hSBA-MenY antibody titers above protocol-specified cut-offs [ Time Frame: One month after vaccination at 12-15 months of age ]
hSBA-MenA and hSBA MenW-135 GMTs and antibody titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 12-15 months of age ]
rSBA-MenA and rSBA-MenW-135 GMTs and antibody titers above protocol-specified cut-offs in a subset of 30% of subjects [ Time Frame: One month after vaccination at 12-15 months of age ]
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 [ Time Frame: One month after vaccination at 12-15 months of age ]
hSBA-MenC, and hSBA-MenY GMTs [ Time Frame: Prior to vaccination at 15-18 months of age ]
hSBA-MenC and MenY titers above protocol-specified cut-offs [ Time Frame: Prior to vaccination at 15-18 months of age ]
Anti-D and anti-T GMCs [ Time Frame: One month after vaccination at 15-18 months of age ]
Anti-PT, anti-FHA and anti-PRN concentrations >=5 ELISA Units (EL.U)/mL [ Time Frame: One month after vaccination at 15-18 months of age ]
Anti-D and anti-T seroprotection rates (antibody concentrations >=0.1 IU/mL) [ Time Frame: One month after vaccination at 15-18 months of age ]
hSBA- MenA, hSBA-MenW-135 GMTs [ Time Frame: One month after vaccination at 15-18 months of age ]
hSBA-MenC and hSBA-MenY titers above protocol-specified cut-off [ Time Frame: One month after vaccination at 15-18 months of age ]
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 [ Time Frame: One month after vaccination at 15-18 months of age ]
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 [ Time Frame: One month after vaccination at 15-18 months of age ]
Occurrence of solicited local and general symptoms [ Time Frame: On Days 0-7 after booster vaccination ]
Occurrence of unsolicited symptoms [ Time Frame: Up to one month (Days 0-30) after booster vaccination ]
Occurrence of serious adverse events (SAEs) and/or the specific AEs of: - new onset of chronic illness(es), - conditions prompting ER visits [ Time Frame: From the first primary study dose up to/excluding the first booster study dose ]
Occurrence of SAEs and/or the specific AEs of: - new onset of chronic illness(es), - rash and/or - conditions prompting emergency room (ER) visits [ Time Frame: From the first booster study dose up to six months after the last vaccination ]

Estimated Enrollment:	1176
Study Start Date:	February 2008
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614614

Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110870, 110871
Study First Received:	January 31, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00614614
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Meningococcal vaccines
Neisseria meningitidis
Vaccines, conjugate
Infants

Toddlers
Humans
Immunogenicity
Safety

Study placed in the following topic categories:

Neisseria meningitidis
Healthy

ClinicalTrials.gov processed this record on January 16, 2009