Haemophilus Influenzae Type b
Conditions
Keywords
primary vaccination course, Haemophilus influenzae type b, infants, children, booster vaccination, immunogenicity, safety, Gram-negative bacterial infections, vaccines, conjugate
Brief summary
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Detailed description
This protocol posting has been updated following protocol amendment 3, dated 12 April 2011. The impacted section is: Eligibility Criteria (Exclusion criteria).
Interventions
BIOLOGICALGSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)
Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.
BIOLOGICALActHIB™
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
BIOLOGICALPentacel™
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination
BIOLOGICALPediarix™
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
BIOLOGICALPrevnar 13™
Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection
BIOLOGICALRotarix™
Two oral doses in primary epoch at 2 and 4 months of age
BIOLOGICALEngerix™-B
Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection
BIOLOGICALInfanrix™
One dose in the booster epoch at 15-18 months of age as intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR\[s\]) can and will comply with the requirements of the protocol (e.g., completion of the diary card, return for follow-up visits). * A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Written informed consent obtained from the subject's parent/LAR. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after a gestation period of minimum 36 weeks. * Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrollment.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Planned administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine and until 30 days after the booster dose. * Previous vaccination against Haemophilus influenzae type b, diphtheria, tetanus, pertussis, Pneumococcus, rotavirus and/or poliovirus; more than one previous dose of hepatitis B vaccine. * History of Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcal, rotavirus, poliovirus, and hepatitis B diseases. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at time of enrollment. All vaccines can be administered to persons with a minor illness. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * Concurrent participation in another clinical study, up to 30 days prior to study entry or at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Child in care. * History of intussusception. * History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception. * History of Severe Combined Immunodeficiency Disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | At 1 month after last dose of primary vaccination | Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL). |
| Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | At 1 month after last dose of primary vaccination | Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus. |
| Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | At 1 month after last dose of primary vaccination | Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL). |
| Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | At 1 month after last dose of primary vaccination | Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL. |
| Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | At 1 month after last dose of primary vaccination | Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL). |
| Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | At 1 month after last dose of primary vaccination | Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group. |
| Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | At 1 month after last dose of primary vaccination | The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity). The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database. |
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL | At 1 month after booster vaccination | Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Prior to the booster vaccination and 1 month after the booster vaccination | Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose. |
| Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | At 1 month after last dose of primary vaccination | Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL). |
| Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | At 1 month after the last dose of primary vaccination | Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination. |
| Antibody Titers for Poliovirus Types 1, 2 and 3 | At 1 month after last dose of primary vaccination | Antibody titers were given as geometric mean titers(GMTs). |
| Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | At 1 month after last dose of primary vaccination | The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection). |
| Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | Prior to the booster vaccination and 1 month after the booster vaccination | Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL). |
| Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | At 1 month after last dose of primary vaccination | Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). |
| Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Prior to booster vaccination | The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection). |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Prior to the booster vaccination and 1 month after the booster vaccination | Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies. |
| Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Prior to the booster vaccination | Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers. |
| Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Prior to booster vaccination | Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated. |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Prior to the booster vaccination and 1 month after the booster vaccination | Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies. |
| Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | pre-booster and one month after booster vaccination | Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL. |
| Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL | Prior to the booster vaccination | Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL). |
| Number of Subjects With Any Solicited Local Symptoms | During a 4-day follow-up period (Days 0-3) following any vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade. |
| Number of Subjects With Any Solicited General Symptoms | During a 4-day follow-up period (Days 0-3) following any vaccination | Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C). |
| Number of Subjects With Any Unsolicited Adverse Events (AEs). | During the 31-day (Day 0-Day 30) follow-up period after primary vaccination | 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 until 6 months following the last primary dose | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With AEs of Specific Interest (AESIs) | From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | At 1 month after last dose of primary vaccination | Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group. |
| Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | At 1 month after last dose of primary vaccination | Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hiberix Group Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Hiberix vaccine was administered intramuscularly in the right thigh. Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | 2,963 |
| ActHIB Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB vaccine co-administered with 3 doses of Pediarix and Prevnar13 vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The ActHIB vaccine was administered intramuscularly in the right thigh. The Pediarix vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. | 520 |
| Pentacel Group Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel vaccine co-administered with 3 doses of Prevnar13 vaccine, 2 or 3 doses of Engerix-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix vaccine at 2 and 4 months of age. The Pentacel vaccine was administered intramuscularly in the right thigh. The Engerix-B vaccine was administered intramuscularly in the left thigh. The Prevnar13 vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix-B vaccine only at 2 and 6 months of age. | 520 |
| Total | 4,003 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Booster Vaccination Phase | Lost to Follow-up | 40 | 5 | 7 |
| Booster Vaccination Phase | Other | 24 | 6 | 4 |
| Booster Vaccination Phase | Protocol Violation | 0 | 0 | 2 |
| Booster Vaccination Phase | Withdrawal by Subject | 3 | 1 | 1 |
| Primary Vaccination Phase | Adverse Event | 14 | 2 | 2 |
| Primary Vaccination Phase | Lost to Follow-up | 171 | 19 | 26 |
| Primary Vaccination Phase | Other | 4 | 9 | 12 |
| Primary Vaccination Phase | Protocol Violation | 40 | 3 | 2 |
| Primary Vaccination Phase | Withdrawal by Subject | 109 | 17 | 21 |
Baseline characteristics
| Characteristic | Hiberix Group | ActHIB Group | Pentacel Group | Total |
|---|---|---|---|---|
| Age, Continuous | 8.6 Weeks STANDARD_DEVIATION 1.08 | 8.6 Weeks STANDARD_DEVIATION 1.13 | 8.7 Weeks STANDARD_DEVIATION 1.12 | 8.61 Weeks STANDARD_DEVIATION 1.09 |
| Sex: Female, Male Female | 1424 Participants | 271 Participants | 258 Participants | 1953 Participants |
| Sex: Female, Male Male | 1539 Participants | 249 Participants | 262 Participants | 2050 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 2,783 / 2,963 | 495 / 520 | 488 / 520 |
| serious Total, serious adverse events | 120 / 2,963 | 24 / 520 | 21 / 520 |
Outcome results
Primary
Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PT | 73.2 EL.U/mL |
| Hiberix Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PRN | 111.6 EL.U/mL |
| Hiberix Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-FHA | 321.8 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PT | 71.9 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PRN | 93.5 EL.U/mL |
| ActHIB Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-FHA | 295.8 EL.U/mL |
| Pentacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PRN | 51.9 EL.U/mL |
| Pentacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-FHA | 174.8 EL.U/mL |
| Pentacel Group | Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) Antibody Concentrations | Anti-PT | 41.9 EL.U/mL |
Comparison: Non-inferiority GMC ratio anti-PT97.5% CI: [0.918, 1.127]Non-inferiority analysis
Comparison: Non-inferiority GMC ratio anti-FHA97.5% CI: [0.983, 1.204]Non-inferiority analysis
Comparison: Non-inferiority GMC ratio anti-PRN97.5% CI: [1.03, 1.382]Non-inferiority analysis
Primary
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Hiberix Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 5.193 µg/mL |
| ActHIB Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 6.743 µg/mL |
| Pentacel Group | Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations | 3.640 µg/mL |
Primary
Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations
Antibody concentrations against S.pneumoniae were given as geometric mean concentrations (GMCs) expressed as microgram per milliliter (µg/mL).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 23F | 2.046 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 18C | 3.655 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 4 | 1.804 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 9V | 2.516 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 14 | 4.506 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 5 | 3.729 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 7F | 4.518 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6A | 3.442 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19F | 2.745 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 1 | 2.515 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6B | 1.065 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19A | 1.556 µg/mL |
| Hiberix Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 3 | 1.056 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 23F | 1.985 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6B | 0.994 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 7F | 4.115 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 9V | 2.431 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 1 | 2.500 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 3 | 1.008 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 4 | 1.803 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 5 | 3.656 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6A | 3.340 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 14 | 4.111 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 18C | 3.507 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19A | 1.553 µg/mL |
| ActHIB Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19F | 2.833 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6B | 0.875 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 14 | 3.938 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 3 | 1.190 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19F | 2.531 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 18C | 3.401 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 1 | 2.442 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 7F | 3.785 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 19A | 1.321 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 5 | 3.530 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 23F | 1.670 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 6A | 3.384 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 9V | 2.226 µg/mL |
| Pentacel Group | Anti-Streptococcus Pneumoniae (S.Pneumoniae) Antibody Concentrations | Anti-Pneumoniae 4 | 1.819 µg/mL |
Comparison: Non-inferiority Anti-Pneumoniae 1 concentrations97.5% CI: [0.873, 1.159]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 3 concentrations97.5% CI: [0.921, 1.192]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 4 concentrations97.5% CI: [0.886, 1.13]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 5 concentrations97.5% CI: [0.874, 1.19]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 6A concentrations97.5% CI: [0.894, 1.188]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 6B concentrations97.5% CI: [0.871, 1.32]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 7F concentrations97.5% CI: [0.964, 1.251]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 9V concentrations97.5% CI: [0.89, 1.204]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 14 concentrations97.5% CI: [0.929, 1.294]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 18C concentrations97.5% CI: [0.9, 1.207]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 19A concentrations97.5% CI: [0.859, 1.167]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 19F concentrations97.5% CI: [0.855, 1.098]Non-inferiority analysis
Comparison: Non-inferiority Anti-Pneumoniae 23F concentrations97.5% CI: [0.862, 1.232]Non-inferiority analysis
Primary
Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value
The cut-off value was defined as a concentration ≥ 8 ED50 (ED50 is the concentration at which the protein exhibits 50% of its maximum activity). The polio testing which started at the Biomnis laboratory was stopped because the polio virus micro-neutralization assays were found to be not in line with the quality standards defined in GSK Biologicals' SOPs. As a result, polio testing was restarted at the GSK laboratory and the results were uploaded into the clinical database.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 3 | 254 Subjects |
| Hiberix Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 2 | 275 Subjects |
| Hiberix Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 1 | 246 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 3 | 181 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 2 | 188 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 1 | 181 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 2 | 183 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 1 | 164 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio 1,2,3 Antibody Titres Greater Than or Equal to Cut-off Value | Anti-Polio 3 | 168 Subjects |
Comparison: Non-inferiority Anti-Polio 1 concentrations97.5% CI: [-2.24, 0.87]Non-inferiority analysis
Comparison: Non-inferiority Anti-Polio 2 concentration97.5% CI: [-1.45, 2.91]Non-inferiority analysis
Comparison: Non-inferiority Anti-Polio 3 concentration97.5% CI: [-2.2, 0.88]Non-inferiority analysis
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL
Non-inferiority of a booster dose of Hiberix co-administered with Infanrix in subjects 15-18 months of age who received 3 primary vaccine doses of Hiberix to a booster dose of ActHIB co-administered with Infanrix in subjects of 15-18 months of age who received 3 primary vaccine doses of ActHIB in terms of immune response to PRP
Time frame: At 1 month after booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL | 333 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL | 231 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 1.0 µg/mL | 184 Subjects |
Primary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL
Non-inferiority of Hiberix to ActHIB, each co-administered with Pediarix, Prevnar13 and Rotarix following 3 primary doses in terms of immune response to PRP (Anti-PRP≥ 0.15 µ g/ml and ≥1.0 µg/mL).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and assay results available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL | 1536 Subjects |
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 1.0 µg/mL | 1291 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL | 265 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 1.0 µg/mL | 246 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL | 234 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL | Anti-PRP ≥ 1.0 µg/mL | 198 Subjects |
Comparison: Non-inferiority Anti-PRP concentration ≥ 1.0 μg/mL95% CI: [-12.28, -4.07]Non-inferiority analysis
Comparison: Non-inferiority Anti-PRP concentration≥ 0.15 μg/mL95% CI: [-1.98, 2.82]Non-inferiority analysis
Primary
Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL)
Non-inferiority of Pediarix co-administered with Hiberix, Prevnar13 and Rotarix compared to Pediarix co-administered with ActHIB, Prevnar13 and Rotarix following 3 primary vaccine doses in terms of immune response to Diphtheria, Tetanus.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-D | 393 Subjects |
| Hiberix Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-T | 393 Subjects |
| ActHIB Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-D | 273 Subjects |
| ActHIB Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-T | 274 Subjects |
| Pentacel Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-T | 249 Subjects |
| Pentacel Group | Number of Subjects With Anti-Protein-D (Anti-D) and Anti-Protein-T (Anti-T) Antibody Concentrations ≥ 0.1 International Units Per Milliliter (IU/mL) | Anti-D | 249 Subjects |
Comparison: Non-inferiority Anti-D antibody concentrations95% CI: [-1.26, 1.81]Non-inferiority analysis
Comparison: Non-inferiority Anti-T antibody concentrations95% CI: [-1.26, 1.8]Non-inferiority analysis
Primary
Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA)
Seroresponse (95%) was defined as the number of subjects showing a concentration above a threshold that leads to 95% seroresponse in the ActHIB group.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PRN | 762 Subjects |
| Hiberix Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PT | 764 Subjects |
| Hiberix Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-FHA | 744 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PRN | 262 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PT | 264 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-FHA | 263 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PT | 201 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-FHA | 191 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (95%) to Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Hemagglutinin (Anti-FHA) | Anti-PRN | 213 Subjects |
Comparison: Difference in seroresponse Anti-FHAp-value: <0.0001t-test, 1 sided
Comparison: Difference in seroresponse Anti-PTp-value: <0.0001t-test, 1 sided
Comparison: Difference in seroresponse Anti-PRNp-value: <0.0001t-test, 1 sided
Secondary
Antibody Titers for Poliovirus Types 1, 2 and 3
Antibody titers were given as geometric mean titers(GMTs).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 2 | 471.8 Titers |
| Hiberix Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 1 | 570.8 Titers |
| Hiberix Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 3 | 982.8 Titers |
| ActHIB Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 2 | 389.9 Titers |
| ActHIB Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 1 | 620.9 Titers |
| ActHIB Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 3 | 963.2 Titers |
| Pentacel Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 1 | 136.0 Titers |
| Pentacel Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 3 | 297.4 Titers |
| Pentacel Group | Antibody Titers for Poliovirus Types 1, 2 and 3 | Anti-Polio 2 | 210.9 Titers |
Secondary
Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) expressed as enzyme-linked immuno-sorbent assay (ELISA) units per milliliter i.e. EL.U/mL.
Time frame: pre-booster and one month after booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, POST | 288.9 EL.U/mL |
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, PRE | 41.3 EL.U/mL |
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, POST | 90.9 EL.U/mL |
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, PRE | 13.3 EL.U/mL |
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, POST | 464.9 EL.U/mL |
| Hiberix Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, PRE | 8.5 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, PRE | 11.2 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, PRE | 8.6 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, POST | 259.2 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, POST | 492.5 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, POST | 93.1 EL.U/mL |
| ActHIB Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, PRE | 40.0 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, POST | 75.3 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, PRE | 22.7 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, PRE | 9.7 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PRN, POST | 153.2 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-PT, PRE | 4.8 EL.U/mL |
| Pentacel Group | Anti-FHA, Anti-PRN and Anti-PT Antibody Concentrations | Anti-FHA, POST | 263.8 EL.U/mL |
Secondary
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) and expressedas milli-international units per milliliter (mIU/mL).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Hiberix Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 3684.3 mIU/mL |
| ActHIB Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 3545.6 mIU/mL |
| Pentacel Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations | 1573.4 mIU/mL |
Secondary
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and expressed as milli-international units per milliliter (mIU/mL).
Time frame: Prior to the booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Hiberix Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL | 268.3 mIU/mL |
| ActHIB Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL | 247.0 mIU/mL |
| Pentacel Group | Anti-Hepatitis B (Anti-HBs) Antibody Concentrations ≥10.0 mIU/mL and ≥6.2 mIU/mL | 156.4 mIU/mL |
Secondary
Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8
Antibody concentrations were tabulated as geometric mean titers (GMTs) and expressed as titers.
Time frame: Prior to the booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 2 | 109.4 Titers |
| Hiberix Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 1 | 106.2 Titers |
| Hiberix Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 3 | 154.8 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 2 | 89.5 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 1 | 101.6 Titers |
| ActHIB Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 3 | 151.9 Titers |
| Pentacel Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 1 | 25.1 Titers |
| Pentacel Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 3 | 40.6 Titers |
| Pentacel Group | Anti-poliovirus Types 1, 2, and 3 Antibody Titres and Titres ≥ 8 | Anti-polio 2 | 48.9 Titers |
Secondary
Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations
Antibody concentrations were given as Geometric Mean Concentrations (GMCs) expressed in micrograms per milliliter (µg/mL).
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | PRE | 0.498 µg/mL |
| Hiberix Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | POST | 48.782 µg/mL |
| ActHIB Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | PRE | 0.467 µg/mL |
| ActHIB Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | POST | 40.293 µg/mL |
| Pentacel Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | PRE | 0.380 µg/mL |
| Pentacel Group | Anti-polyribosylribitol Phosphate (PRP) Antibody Concentrations | POST | 37.543 µg/mL |
Secondary
Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Hiberix Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-D | 2.72 IU/mL |
| Hiberix Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-T | 2.23 IU/mL |
| ActHIB Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-D | 2.45 IU/mL |
| ActHIB Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-T | 2.44 IU/mL |
| Pentacel Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-D | 1.88 IU/mL |
| Pentacel Group | Anti-protein-D (Anti-D) and Anti-protein-T (Anti-T) Antibody Concentrations | Anti-T | 1.72 IU/mL |
Secondary
Number of Subjects With AEs of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 until 6 months following the last primary dose or the receipt of the booster vaccination, whichever comes first
Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With AEs of Specific Interest (AESIs) | 108 Subjects |
| ActHIB Group | Number of Subjects With AEs of Specific Interest (AESIs) | 22 Subjects |
| Pentacel Group | Number of Subjects With AEs of Specific Interest (AESIs) | 15 Subjects |
Secondary
Number of Subjects With AEs of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From booster dose until 6 months following receipt of the booster dose
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With AEs of Specific Interest (AESIs) | 47 Subjects |
| ActHIB Group | Number of Subjects With AEs of Specific Interest (AESIs) | 12 Subjects |
| Pentacel Group | Number of Subjects With AEs of Specific Interest (AESIs) | 7 Subjects |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively.
Evaluation of persistence of anti-D, anti-T antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-D and anti-T antibodies.
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , POST | 330 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , POST | 334 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, PRE | 322 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, POST | 336 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, POST | 336 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , PRE | 52 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , PRE | 151 Subjects |
| Hiberix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, PRE | 292 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, PRE | 218 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , PRE | 89 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , PRE | 27 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , POST | 233 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, POST | 236 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, PRE | 196 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, POST | 236 Subjects |
| ActHIB Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , POST | 234 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, PRE | 154 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , POST | 186 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , POST | 180 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥ 0.1 IU/mL, POST | 186 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥1.0 IU/mL , PRE | 70 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, POST | 186 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-T≥1.0 IU/mL , PRE | 14 Subjects |
| Pentacel Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥1.0 IU/mL, Respectively. | Anti-D≥ 0.1 IU/mL, PRE | 173 Subjects |
Secondary
Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL
The cut-off values were defined as a concentration≥ 6.2 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).
Time frame: Prior to booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥ 6.2 mIU/mL | 311 Subjects |
| Hiberix Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥10.0 mIU/mL | 306 Subjects |
| ActHIB Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥10.0 mIU/mL | 198 Subjects |
| ActHIB Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥ 6.2 mIU/mL | 199 Subjects |
| Pentacel Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥ 6.2 mIU/mL | 156 Subjects |
| Pentacel Group | Number of Subjects With Anti-HB Antibody Concentrations ≥10.0 mlU/mL and ≥6.2mLU/mL | Anti-HBs ≥10.0 mIU/mL | 154 Subjects |
Secondary
Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values
The cut-off values were defined as a concentration≥ 3.3 mIU/mL (seropositivity) and ≥ 10 mIU/mL (seroprotection).
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 3.3 mIU/ml | 362 Subjects |
| Hiberix Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 10 mIU/ml | 362 Subjects |
| ActHIB Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 3.3 mIU/ml | 257 Subjects |
| ActHIB Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 10 mIU/ml | 257 Subjects |
| Pentacel Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 3.3 mIU/ml | 239 Subjects |
| Pentacel Group | Number of Subjects With Anti-HBs Antibody Concentrations Greater Than or Equal to Cut-off Values | Anti-HBs≥ 10 mIU/ml | 239 Subjects |
Secondary
Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8
Anti-polio 1,2,3 antibody titers greater or equal to the cut off value were calculated.
Time frame: Prior to booster vaccination
Population: The analysis was performed on the Booster ATP cohort for immunogenicity which included subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 2 | 285 Subjects |
| Hiberix Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 1 | 294 Subjects |
| Hiberix Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 3 | 283 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 2 | 196 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 1 | 197 Subjects |
| ActHIB Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 3 | 201 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 1 | 124 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 3 | 130 Subjects |
| Pentacel Group | Number of Subjects With Anti-Polio-1,2,3 Antibody Titers ≥ 8 | Anti-polio 2 | 144 Subjects |
Secondary
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Evaluation of persistence of anti-PRP antibodies induced by three primary vaccine doses of Hiberix, and ActHIB, each co-administered with Pediarix, Prevnar 13 and Rotarix, or Pentacel co-administered with Engerix-B, Rotarix and Prevnar 13 prior to the booster dose of Hiberix, ActHIB or Pentacel at 15-18 months of age and evaluation of immunogenicity of a booster dose of Hiberix co-administered with Infanrix, ActHIB co-administered with Infanrix and Pentacel in terms of the percentage of subjects with anti-PRP concentrations ≥0.15 µg/mL, ≥1.0 µg/mL and GMCs one month after the booster dose.
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; POST vaccination | 336 Subjects |
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; PRE vaccination | 106 Subjects |
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; POST vaccination | 333 Subjects |
| Hiberix Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; PRE vaccination | 247 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; PRE vaccination | 172 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; POST vaccination | 235 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; POST vaccination | 231 Subjects |
| ActHIB Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; PRE vaccination | 61 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; PRE vaccination | 116 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; PRE vaccination | 44 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 1 µg/mL; POST vaccination | 184 Subjects |
| Pentacel Group | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations ≥ 0.15 µg/mL and ≥ 1.0 µg/mL | Anti-PRP ≥ 0.15 µg/mL; POST vaccination | 186 Subjects |
Secondary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL
Evaluation of persistence of anti-PT, anti-FHA and anti-PRN antibodies induced by Pediarix or Pentacel and Engerix-B prior to the administration of a booster dose of Hib vaccine at 15-18 months of age and evaluation of immunogenicity of a booster dose of Infanrix co-administered with Hiberix, a booster dose of Infanrix co-administered with ActHIB and a booster dose of Pentacel with respect to anti-PT, anti-FHA and anti- PRN antibodies.
Time frame: Prior to the booster vaccination and 1 month after the booster vaccination
Population: The analysis was performed on the Booster According-to-Protocol (ATP) cohort for immunogenicity that included all evaluable subjects for whom assay results were available for antibodies against at least 1 antigen for the blood sample taken 1 month after the administration of the booster vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, POST | 335 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, PRE | 328 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, PRE | 279 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, POST | 331 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, POST | 335 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, PRE | 243 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, PRE | 223 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, PRE | 168 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, POST | 235 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, POST | 235 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, PRE | 174 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, POST | 233 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, POST | 186 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, PRE | 171 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-FHA, POST | 185 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, POST | 185 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PT, PRE | 81 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ 5 EL.U/mL | Anti-PRN, PRE | 130 Subjects |
Secondary
Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL
Seroresponse was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PRN | 786 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PT | 789 Subjects |
| Hiberix Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-FHA | 791 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PRN | 275 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PT | 275 Subjects |
| ActHIB Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-FHA | 275 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PT | 249 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-FHA | 249 Subjects |
| Pentacel Group | Number of Subjects With Anti-PT, Anti-PRN and Anti-FHA Antibody Concentrations ≥ 5 EL.U/mL | Anti-PRN | 244 Subjects |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Rectal temperature equal to or above (≥) 38 degrees Celsius (°C).
Time frame: During a 4-day follow-up period (Days 0-3) following any vaccination
Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and symptom sheets completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 1450 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 2179 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 1014 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 2478 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 275 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 449 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 398 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 186 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any irritability | 434 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any drowsiness | 378 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any fever | 143 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any loss of appetite | 253 Subjects |
Secondary
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, fever and loss of appetite. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Any fever= Axillary temperature equal to or above (≥) 38 degrees Celsius (°C).
Time frame: Within 4 days (Days 0-3) following the booster dose
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 119 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 857 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 614 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 1293 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 18 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 164 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 250 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 141 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any Fever | 20 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any Loss of appetite | 85 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any Drowsiness | 119 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited General Symptoms | Any Irritability | 201 Subjects |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.
Time frame: Within 4 days (Days 0-3) following the booster dose
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose and had the symptom sheets completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 918 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 659 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 392 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 82 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 127 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 179 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any Swelling | 75 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any Pain | 163 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any Redness | 115 Subjects |
Secondary
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any symptom regardless of intensity grade.
Time frame: During a 4-day follow-up period (Days 0-3) following any vaccination
Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented and with symptom sheets completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 1165 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any pain | 1932 Subjects |
| Hiberix Group | Number of Subjects With Any Solicited Local Symptoms | Any swelling | 834 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 233 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any pain | 366 Subjects |
| ActHIB Group | Number of Subjects With Any Solicited Local Symptoms | Any swelling | 174 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any pain | 370 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any swelling | 195 Subjects |
| Pentacel Group | Number of Subjects With Any Solicited Local Symptoms | Any redness | 257 Subjects |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs).
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day (Day 0-Day 30) follow-up period after primary vaccination
Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 1880 Subjects |
| ActHIB Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 350 Subjects |
| Pentacel Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 324 Subjects |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs).
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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 31 days (Day 0 to Day 30) following the booster dose
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 882 Subjects |
| ActHIB Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 159 Subjects |
| Pentacel Group | Number of Subjects With Any Unsolicited Adverse Events (AEs). | 138 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From the booster dose until 6 months following receipt of the booster dose
Population: Analysis was performed on the Booster Total Vaccinated cohort which included all subjects from Primary Total Vaccinated cohort that received the booster vaccine dose.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With Serious Adverse Events (SAEs) | 29 Subjects |
| ActHIB Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Subjects |
| Pentacel Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 until 6 months following the last primary dose
Population: The analysis was based on the Primary Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine dose documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hiberix Group | Number of Subjects With Serious Adverse Events (SAEs) | 108 Subjects |
| ActHIB Group | Number of Subjects With Serious Adverse Events (SAEs) | 24 Subjects |
| Pentacel Group | Number of Subjects With Serious Adverse Events (SAEs) | 21 Subjects |
Secondary
Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA
Seroresponse (90%) was defined as the number of subjects showing a concentration above a threshold that leads to 90% seroresponse in the ActHIB group.
Time frame: At 1 month after last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PT | 706 Subjects |
| Hiberix Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PRN | 741 Subjects |
| Hiberix Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-FHA | 705 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-FHA | 248 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PRN | 250 Subjects |
| ActHIB Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PT | 248 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PT | 165 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-PRN | 194 Subjects |
| Pentacel Group | Number of Subjects With Seroresponse (90%) to Anti-PT, Anti-PRN and Anti-FHA | Anti-FHA | 166 Subjects |
Secondary
Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL
Evaluation of immunogenicity of a 3-dose primary vaccination course of Prevnar 13 co-administered with Hiberix, Rotarix and Pediarix, of Prevnar 13 co-administered with ActHIB, Rotarix and Pediarix and of Prevnar 13 co-administered with Pentacel, Rotarix and Engerix-B in terms of S.pneumoniae GMCs and antibody concentrations ≥ 0.05µg/mL, ≥ 0.2 µg/mL, ≥ 1.0 µg/mL at one month after the last dose of primary vaccination.
Time frame: At 1 month after the last dose of primary vaccination
Population: The analysis was based on the Primary According-to-Protocol (ATP)cohort for immunogenicity, including all evaluable subjects with 3 vaccine doses administered and for whom assay results were available for antibodies against at least one antigen for the blood sample taken 1 month after the last vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19F | 383 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 7F | 379 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6B | 378 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19F | 357 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 7F | 386 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 9V | 338 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 18C | 377 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 9V | 385 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6B | 232 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 9V | 385 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 14 | 384 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 18C | 380 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 23F | 297 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 7F | 386 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 23F | 384 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6A | 357 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6B | 351 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 1 | 382 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19A | 383 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6A | 379 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 3 | 379 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19A | 290 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 5 | 377 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 4 | 389 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 5 | 354 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19F | 384 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 5 | 379 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 4 | 389 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 3 | 382 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 4 | 318 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 18C | 361 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 3 | 188 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 14 | 381 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6A | 381 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19A | 379 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 1 | 384 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 14 | 360 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 1 | 334 Subjects |
| Hiberix Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 23F | 376 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 4 | 226 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 1 | 268 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 3 | 269 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 4 | 268 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 5 | 266 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6A | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6B | 260 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 18C | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19A | 265 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 4 | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6B | 242 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 9V | 269 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 18C | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19A | 259 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19F | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 7F | 264 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 9V | 234 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 7F | 269 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 9V | 270 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 14 | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19F | 268 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 23F | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 1 | 267 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 3 | 268 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 5 | 265 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6A | 265 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 7F | 269 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 14 | 265 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 23F | 265 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 1 | 239 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 3 | 140 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 5 | 250 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6A | 253 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6B | 151 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 14 | 250 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 18C | 256 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19A | 200 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19F | 254 Subjects |
| ActHIB Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 23F | 208 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19A | 235 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 1 | 213 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19F | 231 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 23F | 231 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 19F | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 18C | 229 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 9V | 243 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 4 | 247 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 3 | 138 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 7F | 246 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 4 | 247 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 4 | 199 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19A | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 1 | 245 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 5 | 225 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 18C | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 19A | 164 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6A | 229 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 14 | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 3 | 243 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 6B | 117 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 7F | 239 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6B | 241 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 9V | 203 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 3 | 243 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 6A | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 5 | 245 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 1 | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 23F | 180 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6A | 243 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 23F | 244 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 6B | 224 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 19F | 245 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 1.0 µg/mL, Anti-Pneumoniae 14 | 223 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 9V | 246 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 5 | 246 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 14 | 241 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.05 µg/mL, Anti-Pneumoniae 7F | 246 Subjects |
| Pentacel Group | Number of Subjects With S.Pneumoniae Antibody Concentrations ≥ 0.05 µg/mL, ≥ 0.2 µg/mL and ≥1.0 µg/mL | ≥ 0.2 µg/mL, Anti-Pneumoniae 18C | 244 Subjects |