The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
657
Single dose, licensed formulation, intramuscular into right thigh
Single co-administered dose, intramuscular into left thigh
Single dose, investigational formulation A or B, intramuscular into right thigh
GSK Investigational Site
Santo Domingo, Dominican Republic
GSK Investigational Site
Santo Domingo, Distrito Nacional, Dominican Republic
GSK Investigational Site
Espoo, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Helsinki, Finland
GSK Investigational Site
Jarvenpaa, Finland
GSK Investigational Site
Kokkola, Finland
GSK Investigational Site
Kuopio, Finland
GSK Investigational Site
Lahti, Finland
GSK Investigational Site
Oulu, Finland
...and 6 more locations
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-D and Anti-T Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time frame: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
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Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentration
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Time frame: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentration for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentration for Anti-poliovirus Type 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PRP Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time frame: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PNE Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PNE Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time frame: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time frame: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Time frame: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptom
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptoms
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptom
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever \[axillary temperature above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Unsolicited AEs
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time frame: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time frame: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)