The purpose of this study was to assess the safety and immunogenicity of GSK's combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV's DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
500
3 doses (1 each at 2, 4 and 12 months of age) of DTPa-HBV-IPV/Hib vaccine administered by intramuscular injection into the right thigh
3 doses (1 each at 2, 4 and 12 months of age) of DTaP5-HBV-IPV-Hib vaccine administered by intramuscular injection into the right thigh
3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13-valent conjugate vaccine administered by intramuscular injection into the left thigh
GSK Investigational Site
Rosenheim, Bavaria, Germany
GSK Investigational Site
Schönau am Königssee, Bavaria, Germany
GSK Investigational Site
Leipzig, Brandenburg, Germany
GSK Investigational Site
Wolfsburg, Lower Saxony, Germany
GSK Investigational Site
Hürth, North Rhine-Westphalia, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, Germany
GSK Investigational Site
Bramsche, Germany
GSK Investigational Site
Erfurt, Germany
GSK Investigational Site
Mönchengladbach, Germany
...and 10 more locations
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations at Month 11, Based on Per Protocol Set (PPS)
Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in microgram per milliliter (μg/mL), as assessed by Enzyme-linked immunosorbent assay (ELISA).
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
Percentage of Subjects With Anti-PRP Antibody Concentrations Equal to or Above (≥) 5 µg/mL at Month 11, Based on PPS
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
Anti-PRP Antibody Concentrations at Month 11, Based on the Exposed Set (ES)
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 5 µg/mL at Month 11, Based on ES
The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA.
Time frame: At Month 11 (i.e., 1-month post-booster vaccination)
Percentage of Subjects With Anti-PRP Antibody Concentration ≥ 0.15 µg/mL
The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for short-term protection was reported. The threshold for short-term protection is 0.15 µg/mL.
Time frame: At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Percentage of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for long-term protection was reported. The threshold for long-term protection is 1.0 µg/mL.
Time frame: At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA.
Time frame: At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
Number of Subjects With Unsolicited Adverse Events (AEs)
AEs are defined as any untoward medical occurrence in a subject or subjects, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame: During the 31-day (Days 1-31) follow-up period after each vaccination (vaccines administered at 2,4 and 12 months of age)
Number of Subjects With Serious Adverse Events (SAEs)
A SAEs is defined as any untoward medical occurrence that, at any dose, result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect.
Time frame: Throughout the entire period of the study (from Day 1 up to study end [Month 11])
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