This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00412854). This Phase IIIB study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese children 18 to 24 months of age, in terms of safety and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
467
GSK Investigational Site
Liucheng County, Guangxi, China
GSK Investigational Site
Mengshan, China
GSK Investigational Site
Wuzhou, China
Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations
Geometric mean concentrations are given in microgram per milliliter (μg/mL).
Time frame: One month after booster vaccination
Anti-diphtheria Toxoid Antibody Concentrations
Geometric mean concentrations are given in international Unit per milliliter (IU/mL).
Time frame: One month after booster vaccination
Anti-tetanus Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: One month after booster vaccination
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Geometric mean concentrations are given in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Time frame: One month after booster vaccination
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Time frame: One month after booster vaccination
Anti-PRP Antibody Concentrations
Geometric mean concentrations are given in μg/mL.
Time frame: Before booster vaccination
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Anti-diphtheria Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: Before booster vaccination
Anti-tetanus Toxoid Antibody Concentrations
Geometric mean concentrations are given in IU/mL.
Time frame: Before booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Geometric mean concentrations are given in EL.U/mL.
Time frame: Before booster vaccination
The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Assay cut-offs indicating seroprotection or seropositivity for the different antigens were the following: anti-PRP antibody concentrations ≥ 0.15 µg/mL, anti-diphtheria and anti-tetanus antibody concentrations ≥ 0.1 IU/mL, anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 20 EL.U/mL.
Time frame: Before booster vaccination
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Time frame: During the 4-day follow-up period after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: During the 31-day follow-up period after booster vaccination
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in isability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time frame: During the 31-day follow-up period after booster vaccination