The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
585
3 doses administered intramuscularly in the right thigh.
3 doses administered intramuscularly in the right thigh
4 doses administered intramuscularly in the upper left thigh
4 doses administered intramuscularly in the right thigh
2 or 3 doses administered intramuscularly in the upper left thigh
1 dose administered intramuscularly in the right thigh
1 dose administered intramuscularly in the left thigh
3 doses administered intramuscularly in the lower left thigh
2 doses administered orally
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Anaheim, California, United States
GSK Investigational Site
Daly City, California, United States
GSK Investigational Site
Fresno, California, United States
Antibody Concentrations for Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN. The results for the Infanrix hexa Group and Pediarix Group were the primary outcome variables.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Tetanus (T).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Number of Seroprotected Subjects Against Diphtheria (D).
A seroprotected subject was defined a a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination.
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seroprotection cut-off of 0.1 IU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Polyribosyl Ribitol Phosphate (Anti-PRP).
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the assay cut-off of 1 µg/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Seroprotected Subjects Against Hepatitis B (Anti-HBs).
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mili-International units per mililiter (mIU/mL).
Time frame: At Month 5, one month after the third dose of the primary vaccination
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time frame: At Month 5, one month after the third dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness (Red) and swelling (Swe). Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness/Swelling: \> 5 millimeters (mm); Grade 3 Redness (Red)/Swelling (Swe): \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 1.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 2.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Feve:r \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following Dose 3.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following any dose.
Number of Subjects With Specific Adverse Events (AEs).
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time frame: From Month 0 up to 6 months post primary-vaccination (Month 10)
Number of Subjects With 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.
Time frame: During the 31-day (Days 0-30) post-primary vaccination period.
Number of Subjects With Serious Adverse Events (SAEs).
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: From Month 0 up to 6 months post-primary vaccination (Month 10)
Number of Seroprotected Subjects Against Anti-T.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-D.
A seroprotected subject was defined a subject with antibody concentrations ≥ 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 (At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-T.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-D.
Concentrations were expressed as GMCs for the seropositivity cut-off of 0.1 IU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
A seropositive subject was defined as a subject with antibody concentrations above to or equal to (≥) 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN.
Concentrations were expressed as geometric mean concentrations (GMCs) for the following cut-offs:2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 5 [Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [Month 14-17 one month after the booster dose (Dose 4)]
Number of Subjects With a Booster Response for Anti-PT, Anti-FHA and Anti-PRN.
Booster response to PT, FHA and PRN antigens was defined as: * For subjects with pre-vaccination antibody concentration below the assay cut off, post-vaccination antibody concentration equal or above 4 times the assay cut-off. * For subjects with pre-vaccination antibody concentration between the assay cut off and below 4 times the assay cut-off, post-vaccination antibody concentration equal or above 4 times the pre-vaccination antibody concentration. * For subjects with pre-vaccination antibody concentration equal or above 4 times the assay cut-off, post-vaccination antibody concentration of at least two times the pre-vaccination antibody concentration. The assay cut off is 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, and 2.187 IU/mL for anti-PRN.
Time frame: At Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-PRP.
A seroprotected subject was defined as a subject with anti-PRP concentrations ≥ 0.15 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1 µg/mL.
The cut-off for this assay was an anti-PRP concentration ≥ 1 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose4)]
Antibody Concentrations for Anti-PRP.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 1 µg/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)] and at Visit 6 [At Month 14-17 one month after the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-polio Types 1, 2 and 3.
A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titres ≥ 8 dilution.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs) for the cut-off of 8 dilution.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Seroprotected Subjects Against Anti-HBs.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Antibody Concentrations for Anti-HBs.
Antibody concentrations were expressed as GMCs for the seroprotection cut-off of 10 mIU/mL.
Time frame: At Visit 5 [At Month 13-16 before the booster dose (Dose 4)]
Number of Subjects With Solicited Local Symptoms.
The solicited local symptoms assessed were pain, redness and swelling. Any = any reports of the specific symptom irrespective of intensity grade; above or equal (≥); Grade 2 Redness (Red)/Swelling (Swe): \> 5 millimeters (mm); Grade 3 Redness/Swelling: \> 20 mm; Grade 2 Pain = Moderate: cries/protests on touch; Grade 3 Pain = Severe: Cries when limb is moved/spontaneously painful. Grade = G; Medical Advice = MA.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Solicited General Symptoms.
The solicited general symptoms assessed were Drowsiness, Irritability/Fussiness, Loss Of Appetite and Fever (defined as temperature ≥ 38.0°C). Any = any reports of the specific symptom irrespective of intensity grade; Grade 2 (G2) Drowsiness = Drowsiness that interfered with normal activity; Grade 2 Irritability/Fussiness = Moderate: Cried more than usual/interfered with normal activity; Grade 2 Loss of appetite = Ate less than usual/interfered with normal activity; Grade 2 Fever: \> 39.0 °C and ≤ 40.0 °C; Grade 3 (G3) Drowsiness/Irritability/Fussiness = symptom that prevented normal activity; Grade 3 Loss of appetite = Did not eat at all; Grade 3 Fever: \> 40.0 °C; Related (Rel) = Symptom which was assessed by the investigator as related to vaccination.
Time frame: During the 4-day (Days 0-3) post-booster vaccination.
Number of Subjects With Specific AEs.
Occurrence of specific adverse events, i.e., new onset chronic diseases (e.g. autoimmune disorders, asthma, type I diabetes and allergies)
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
Number of Subjects With 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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
Number of Subjects With SAEs.
SAEs were defined as medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Time frame: During the 31-day (Days 0-30) post-booster vaccination.
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GSK Investigational Site
Hayward, California, United States
GSK Investigational Site
Oakland, California, United States
GSK Investigational Site
Pleasanton, California, United States
GSK Investigational Site
Roseville, California, United States
GSK Investigational Site
Sacramento, California, United States
...and 33 more locations