This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
In this long-term follow-up study, no new subjects will be recruited. All subjects participating in this long-term follow-up study should have already participated in a previous study. No vaccine will be administered during the persistence phase of the study. This Protocol Posting has been updated following Protocol amendment 3, September 2009.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
270
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Norwich, Connecticut, United States
GSK Investigational Site
Marietta, Georgia, United States
GSK Investigational Site
Woodstock, Georgia, United States
GSK Investigational Site
Waukee, Iowa, United States
GSK Investigational Site
Bardstown, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Louisville, Kentucky, United States
GSK Investigational Site
Bossier City, Louisiana, United States
...and 11 more locations
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Anti-PRP Geometric Mean Concentrations (GMCs)
Concentration were measured as Geometric Mean Concentrations expressed as microgram per milliliter (µg/mL). Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenC Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
hSBA-MenY Geometric Mean Titers (GMTs)
Titers are given as Geometric Mean Titers as measured by human serum bactericidal assay (hSBA) and expressed as the reciprocal of the dilution resulting in 50% inhibition. Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenY Titers Greater Than or Equal to 1:4
Results up to 5 years after the fourth dose are presented.
Time frame: One year, three years, and five years after the fourth dose vaccination.
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