The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
450
Intramuscular injection, administered as a single dose
Intramuscular injection, administered as a single dose
Intramuscular injection, administered as a single dose
GSK Investigational Site
Ansan, South Korea
GSK Investigational Site
Bucheon-Si, GyeongGi-do,, South Korea
GSK Investigational Site
Daejeon, South Korea
Number of Subjects Reporting Grade 3 Adverse Events
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
Time frame: Within 31 days (Day 0 - Day 30) after booster vaccination.
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Time frame: Within 4 days (Days 0 to 3) after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Time frame: Within 31 days (Days 0 to 30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events
Serious adverse events are 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.
Time frame: After booster vaccination up to study end (Month 0 to Month 1)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
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GSK Investigational Site
Gyeonggi-do, South Korea
GSK Investigational Site
GyeongSangNam-do, South Korea
GSK Investigational Site
Iksan, South Korea
GSK Investigational Site
Jeju City, South Korea
GSK Investigational Site
Jeonju Jeonbuk, South Korea
GSK Investigational Site
Pusan, South Korea
GSK Investigational Site
Seoul, South Korea
...and 4 more locations
Time frame: One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Time frame: One month after booster vaccination (Month 1)
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
Time frame: One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
Time frame: One month after booster vaccination (Month 1)
Concentration of Antibodies Against Protein D (PD)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
Time frame: One month after booster vaccination (Month 1)
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
Time frame: One month after booster vaccination (Month 1)