This protocol posting deals with objectives \& outcome measures of an extension phase when subjects are aged 3, 4 and 6 years of age. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT number = NCT00463437). The purpose of this study is to evaluate the persistence of pneumococcal, meningococcal serogroup C, Hib and Hepatits B antibodies after booster vaccination, when the subjects are aged 3, 4 and 6 years. No vaccine will be administered during this persistence phase of the study.
This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 107005 and will not be further randomized in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
582
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study.
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age and as booster dose at 11-18 months of age. No vaccine was administered during this long-term follow up study
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (all countries) and as booster dose at 11-18 months of age (Germany and Poland). No vaccine was administered during this long-term follow up study
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
Intramuscular injection into the thigh as booster dose at 11-18 months of age (Spain). No vaccine was administered during this long-term follow up study
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, Germany
GSK Investigational Site
Tettnang, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
...and 18 more locations
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 3 years of age
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 6 years of age
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:8. The rSBA-MenC assay was performed at the Public Health England (PHE) laboratory at 6 years of age while the GSK laboratory was used for testing at 3 and 4 years of age.
Time frame: At 4 years of age
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
The cut-off value was defined as a titer equal to or above 1:128.
Time frame: At 3 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 3 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Time frame: At 3 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL,
Time frame: At 3 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 3 years of age
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titre of 8.
Time frame: At 3 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 3 years of age
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 3 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 3 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 3 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 4 years of age
Number of Subjects With an rSBA-MenC Titer Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Time frame: At 4 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration equal to or above 0.15 microgram per milliliter (μg/mL) and equal to or above 1.0 μg/mL.
Time frame: At 4 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Time frame: At 4 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 4 years of age
Number of Subjects With Opsonophagocytic Activity
Opsonophagocytic activity was measured by a killing-assay. The results were presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer of 8.
Time frame: At 4 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 4 years of age
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 4 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 4 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 4 years of age
Number of Subjects With rSBA-MenC Titer Equal to or Above Cut-off Value
rSBA-MenC antibody cut-off value assessed was equal to or above 1:128.
Time frame: At 6 years of age
rSBA-MenC Titers
Titers are given as Geometric Mean Titers (GMTs).
Time frame: At 6 years of age
Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations Equal to or Above Cut-off Values
The cut-off values were defined as a concentration ≥ 0.15 microgram per milliliter (μg/mL) and ≥ 1.0 μg/mL.
Time frame: At 6 years of age
Anti-PRP Concentrations
Concentrations were defined as Geometric Mean Concentrations (GMCs) in μg/mL
Time frame: At 6 years of age
Antibody Concentrations Against Vaccine Pneumococcal Serotypes
Antibody concentrations were expressed as GMCs in μg/mL. Vaccine pneumococcal serotypes assessed included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: At 6 years of age
Concentration of Antibodies Against Protein D
Concentrations were expressed as GMCs in enzyme-linked immunosorbent-assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At 6 years of age
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values as Measured by ELISA.
Cut-off values assessed were defined as equal to or above 10 milli-international units per milliliter (mIU/mL) or equal to or above 100 mIU/mL.
Time frame: At 3 and 4 years of age
Anti-HBs Antibody Concentrations as Measured by ELISA
Concentrations were expressed as GMCs in mIU/mL.
Time frame: At 3 and 4 years of age
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above Cut-off Values
Cut-off values assessed were defined as equal to or above (≥) 6.2 milli-international units per milliliter (mIU/mL), 10 mIU/mL and 100 mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by Enzyme-Linked Immunosorbent Assay (ELISA). The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA). Anti-HBs seroprotection was redefined as CLIA concentration above 10 mIU/mL.
Time frame: At 3, 4 and 6 years of age
Anti-HBs Antibody Concentrations
Concentrations were expressed as GMCs in mIU/mL. Note: A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL) when tested by ELISA. The tables show both the results obtained by ELISA as well as updated results following complete retesting and reanalysis by a Chemiluminescence immunoassay (CLIA).
Time frame: At 3, 4 and 6 years of age
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as being related to the study procedures.
Time frame: From last study contact of the study (NCT00463437) at 17-24 months of age until 6 years of age
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