Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-Priming With GSK Vaccine 792014 - Full Text View

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

Purpose

The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Condition	Intervention	Phase
Invasive Disease Caused by Neisseria Meningitidis Due to Serogroups A, C, W-135, Y	Biological: GSK Biologicals' Meningococcal vaccine GSK134612 Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 Biological: Infanrix® Biological: ActHIB® Biological: Pediarix®	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Efficacy Study
Official Title:	Immunogenicity & Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 or 15-18 Months of Age (co-Administered With Infanrix®) in Primed Healthy Toddlers

Resource links provided by NLM:

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

hSBA-MenA, hSBA-MenW-135, hSBA-MenC, and hSBA-MenY titers above protocol specified cut-off in groups A and C [ Time Frame: One month post vaccination at 12-15 months of age (Group A), one month post vaccination at 15-18 months of age (Group C) ] [ Designated as safety issue: No ]
hSBA-MenC and hSBA-MenY GMTs in groups A, B and C [ Time Frame: One month post vaccination at 12-15 months of age (Groups A and B), one month post vaccination at 15-18 months of age (Group C) ] [ Designated as safety issue: No ]
hSBA-MenC and hSBA-MenY titers above protocol-specified cut-off in group B [ Time Frame: One month post vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
Anti-diphtheria antibody concentrations above protocol-specified cut-off in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-tetanus antibody concentrations above protocol-specified cut-off in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-PT, anti-FHA and anti-PRN GMCs in groups C and D [ Time Frame: One month post vaccination at 15-18 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

hSBA-MenC and hSBA-MenY antibody titers in groups A and B [ Time Frame: One month after vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
hSBA-MenA and hSBA MenW-135 GMTs and antibody titers in group A [ Time Frame: One month after vaccination at 12-15 months of age ] [ Designated as safety issue: No ]
hSBA-MenC, and hSBA-MenY GMTs and titers in group C [ Time Frame: Prior to vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-D and anti-T GMCs [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-PT, anti-FHA and anti-PRN concentrations [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
hSBA-MenA, hSBA-MenW-135 GMTs in group C [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-D concentrations in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-T concentrations in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Anti-PT, anti-FHA and anti-PRN GMCs in groups A and B [ Time Frame: One month after vaccination at 15-18 months of age ] [ Designated as safety issue: No ]
Occurrence of solicited local and general symptoms [ Time Frame: 8 days following each booster vaccination. ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms [ Time Frame: 31 days following each booster vaccination. ] [ Designated as safety issue: No ]
Serious adverse events (SAEs) [ Time Frame: From the first primary study dose up to/excluding the first booster study dose ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Serious adverse events (SAEs) [ Time Frame: From the first booster phase visit up to six months after the last vaccination ] [ Designated as safety issue: No ]
Specific AEs of:new onset of chronic illness(es), rash and/or conditions prompting emergency room (ER) visits [ Time Frame: From the first booster phase visit up to six months after the last vaccination ] [ Designated as safety issue: No ]
Anti-D and anti-T seroprotection rates [ Time Frame: One month after vaccination with Infanrix® at 15-18 months of age ] [ Designated as safety issue: No ]

Enrollment:	1548
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK134612 at 12-15 months of age followed by Infanrix® three months later	Biological: GSK Biologicals' Meningococcal vaccine GSK134612 One dose in the booster phase as intramuscular injection Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection Biological: Infanrix® one dose as intramuscular injection Biological: Pediarix® three doses in the priming phase as intramuscular injection
Group B: Experimental Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK792014 at 12-15 months of age followed by Infanrix® three months later	Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection Biological: Infanrix® one dose as intramuscular injection Biological: Pediarix® three doses in the priming phase as intramuscular injection
Group D: Active Comparator Subjects were primed with 3 doses of ActHIB® and Pediarix® at 2, 4 and 6 months of age and vaccinated with Infanrix® at 15-18 months of age	Biological: Infanrix® one dose as intramuscular injection Biological: ActHIB® three doses in the priming phase as intramuscular injection Biological: Pediarix® three doses in the priming phase as intramuscular injection
Group C: Experimental Subjects who were primed with 3 doses of GSK792014 and Pediarix® at 2, 4 and 6 months of age and vaccinated with one dose of GSK134612 and Infanrix® at 15-18 months of age	Biological: GSK Biologicals' Meningococcal vaccine GSK134612 One dose in the booster phase as intramuscular injection Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 Three doses in the priming phase and, for Group B, one dose in the booster phase as intramuscular injection Biological: Infanrix® one dose as intramuscular injection Biological: Pediarix® three doses in the priming phase as intramuscular injection

Detailed Description:

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

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:

Exclusion criteria for enrolment (primary phase)

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 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).

Exclusion criteria for enrolment (booster phase)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
Chronic administration (defined as more than 14 days) 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 entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
Previous administration of a booster dose of Hib prior to entry to the booster phase.
Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
History of Neisseria meningitidis, Hib, diphtheria, tetanus 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 within the past 3 months 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

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Locations

United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Dothan, Alabama, United States, 36305
GSK Investigational Site
Birmingham, Alabama, United States, 35244
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
GSK Investigational Site
Benton, Arkansas, United States, 72019
United States, California
GSK Investigational Site
West Covina, California, United States, 91790
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Fresno, California, United States, 93726
United States, Florida
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
GSK Investigational Site
Plantation, Florida, United States, 33324
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30062
GSK Investigational Site
Woodstock, Georgia, United States, 30189
United States, Idaho
GSK Investigational Site
Nampa, Idaho, United States, 208 463 3126
United States, Iowa
GSK Investigational Site
Des Moines, Iowa, United States, 50312
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
United States, Kansas
GSK Investigational Site
Ark City, Kansas, United States, 67005
United States, Kentucky
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
GSK Investigational Site
Lexington, Kentucky, United States, 40503
United States, Louisiana
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02130
GSK Investigational Site
Fall River, Massachusetts, United States, 02724
United States, Michigan
GSK Investigational Site
Richland, Michigan, United States, 49083
GSK Investigational Site
Stevensville, Michigan, United States, 49127
GSK Investigational Site
Nies, Michigan, United States, 49120
GSK Investigational Site
Kalamazoo, Michigan, United States, 49008
GSK Investigational Site
Portage, Michigan, United States, 49024
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Nevada
GSK Investigational Site
Henderson, Nevada, United States, 89015
United States, North Carolina
GSK Investigational Site
Clyde, North Carolina, United States, 28721
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
Huber Heights, Ohio, United States, 45424
United States, Oregon
GSK Investigational Site
Gresham, Oregon, United States, 97030
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Texas
GSK Investigational Site
Sugarland, Texas, United States, 77479
GSK Investigational Site
Amarillo, Texas, United States, 79124
GSK Investigational Site
Galveston, Texas, United States, 77555-1119
United States, Utah
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Roy, Utah, United States, 84067
GSK Investigational Site
St. George, Utah, United States, 84790
GSK Investigational Site
Ogden, Utah, United States, 84405
GSK Investigational Site
Provo, Utah, United States, 84604
GSK Investigational Site
Syracuse, Utah, United States, 84075
GSK Investigational Site
South Jordan, Utah, United States, 84095
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110870, 110871
Study First Received:	January 31, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00614614 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Human serum bactericidal assay
Meningococcal vaccines
Neisseria meningitidis
Vaccines, conjugate
Toddlers

Immunogenicity
Safety
Meningococcal disease
Booster vaccination

ClinicalTrials.gov processed this record on November 27, 2009