The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 \[DTPA (BOOSTRIX)-047\]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
601
• All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.
• All subjects will receive Infanrix hexa co-administered with Prevenar13\* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. \*In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
GSK Investigational Site
Carlton, Victoria, Australia
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Halifax, Nova Scotia, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Brno, Czechia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Ostrava - Vitkovice, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Kokkola, Finland
...and 20 more locations
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (\<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
Time frame: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
Time frame: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
Time frame: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.
Time frame: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
Time frame: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL.
Time frame: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Time frame: Before the first dose of Infanrix hexa
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Time frame: Before the first dose of Infanrix hexa
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Time frame: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Time frame: 1 month after the last dose of the primary vaccination
Anti-Polio Type 1, 2 and 3 Antibody Titers
Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).
Time frame: 1 month after the last dose of the primary vaccination
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
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Time frame: 1 month after the last dose of the primary vaccination
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.
Time frame: 1 month after the last dose of the primary vaccination
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Time frame: 1 month after the last dose of the primary vaccination
Anti-pneumococcal Antibody Concentrations
Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.
Time frame: 1 month after the last dose of the primary vaccination
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Time frame: 1 month after the last dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.
Time frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever \[defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.
Time frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Unsolicited Adverse Events
An unsolicited AE covers 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 and 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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (days 0-30) follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)