Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria, Tetanus, Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccin
Conditions
Keywords
Prophylaxis diphtheria, Hib & meningococcal serogroup A & C disease
Brief summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Detailed description
This study will be conducted in two stages. In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepB/Hib-MenAC or Tritanrix-HepB/Hib (active control) at 15 to 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child (this booster phase is no longer recruiting). In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate and/or MenC containing vaccine at 15-24 months in an open manner (this booster phase is not yet recruiting). Up to four blood samples will be taken: before and one month after the administration of the DTP booster dose and of Mencevax ACWY. To comply with the immunisation calender of Thailand, at 15-24 months all subjects will receive OPV. At 16-25 months 2 doses of Japanese Encephalitis (JE) vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered.
Interventions
BIOLOGICALTritanrix-HepB/Hib-MenAC
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine
BIOLOGICALMencevax ACWY
GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine
BIOLOGICALTritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine
BIOLOGICALMeningitec
Wyeth's MenC CRM197 conjugated vaccine, Meningitec
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
427 Days to 730 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female between and including 15 and 24 months of age * Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
Exclusion criteria
* Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480). * History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value | One month Post-Booster vaccination at 15-24 months of age | Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. |
| Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value | One Month Post-Booster vaccination at 15-24 months of age | Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype). |
| Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value | One Month Post-Booster vaccination at 15-24 months of age | Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-SBA-MenC Antibody Titers | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody titers were presented as geometric mean titers (GMTs). |
| Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype). |
| Anti-rSBA-MenA Antibody Titers | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody titers were presented as geometric mean titers (GMTs). |
| Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL). |
| Anti-PSC Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml). |
| Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL). |
| Anti-PSA Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter (). |
| Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | One month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were \< 0.1 IU/ml when assessed by ELISA. |
| Anti-D Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL). |
| Anti-TT Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL). |
| Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | One month Post-Booster vaccination | Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL). |
| Anti-BPT Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). |
| Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL). |
| Anti-HBs Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Day 0 to Day 3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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) | Up to one month Post-Booster vaccination | 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. |
| Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL). |
| Anti-PRP Antibody Concentrations | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). |
| Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age | Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACAC GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. | 249 |
| ACHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm | 123 |
| HibACPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm | 79 |
| HibHibPS GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. | 41 |
| CC GROUP Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) were boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. | 125 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Migrated/moved from study area | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | ACAC GROUP | ACHibPS GROUP | HibACPS GROUP | HibHibPS GROUP | CC GROUP | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 17.90 Months STANDARD_DEVIATION 0.52 | 17.8 Months STANDARD_DEVIATION 0.59 | 17.7 Months STANDARD_DEVIATION 0.59 | 17.7 Months STANDARD_DEVIATION 0.67 | 17.8 Months STANDARD_DEVIATION 0.55 | 17.82 Months STANDARD_DEVIATION 0.56 |
| Race/Ethnicity, Customized East - South East Asian | 249 Participants | 123 Participants | 79 Participants | 41 Participants | 125 Participants | 617 Participants |
| Sex: Female, Male Female | 132 Participants | 56 Participants | 38 Participants | 21 Participants | 55 Participants | 302 Participants |
| Sex: Female, Male Male | 117 Participants | 67 Participants | 41 Participants | 20 Participants | 70 Participants | 315 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 123 | 0 / 79 | 0 / 41 | 0 / 125 |
| other Total, other adverse events | 234 / 249 | 115 / 123 | 75 / 79 | 38 / 41 | 113 / 125 |
| serious Total, serious adverse events | 8 / 249 | 0 / 123 | 1 / 79 | 1 / 41 | 1 / 125 |
Outcome results
Primary
Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT versus Tritanrix-Hepb/Mencevax+Tritanrix-HepB/Hiberix groups.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value | 100 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value | 100 Percentage |
Comparison: Demonstration of non-inferiority of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus the Tritanrix-HepB/Hiberix vaccine when used as a booster vaccine in Tritanrix-HepB/Hib-MenAC-TT primed subjects in terms of the percentage of subjects with an anti-PRP concentration ≥ 1.0 µg/mL.95% CI: [-1.53, 3.05]
Primary
Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Time frame: One month Post-Booster vaccination at 15-24 months of age
Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.This primary analysis focused only on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group versus TRITANRIX-HEPB+Mencevax + Meningitec Group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC GROUP | Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value | 100 Percentage |
| CC GROUP | Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value | 100 Percentage |
Comparison: Demonstration of non-inferiority of a fourth dose of the Tritanrix-HepB/Hib-MenAC-TT vaccine versus a fourth dose of the Tritanrix-HepB/Hiberix and Meningitec vaccine given concomitantly in terms of the percentage of subjects with an SBA-MenC titre ≥ 1:128.95% CI: [-1.53, 3.05]
Primary
Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Time frame: One Month Post-Booster vaccination at 15-24 months of age
Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This primary analysis focused on subjects from Tritanrix-Hepb/Hib-MenAC-TT Group only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value | rSBA-MenA (L11) | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value | rSBA-MenA (L10) | 100 Percentage |
Secondary
Anti-BPT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Pre-Booster) | 11.7 EL.U/ml |
| ACAC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Post-Booster) | 122.1 EL.U/ml |
| CC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Pre-Booster) | 10.5 EL.U/ml |
| CC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Post-Booster) | 115.9 EL.U/ml |
| HibACPS GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Pre-Booster) | 10.6 EL.U/ml |
| HibACPS GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Post-Booster) | 129.1 EL.U/ml |
| HibHibPS GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Post-Booster) | 112.6 EL.U/ml |
| HibHibPS GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Pre-Booster) | 10.5 EL.U/ml |
| CC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Pre-Booster) | 11.1 EL.U/ml |
| CC GROUP | Anti-BPT Antibody Concentrations | Anti-BPT (Post-Booster) | 102.5 EL.U/ml |
Secondary
Anti-D Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-D Antibody Concentrations | Anti-D (Pre-Booster) | 0.126 IU/mL |
| ACAC GROUP | Anti-D Antibody Concentrations | Anti-D (Post-Booster) | 4.705 IU/mL |
| CC GROUP | Anti-D Antibody Concentrations | Anti-D (Pre-Booster) | 0.137 IU/mL |
| CC GROUP | Anti-D Antibody Concentrations | Anti-D (Post-Booster) | 5.003 IU/mL |
| HibACPS GROUP | Anti-D Antibody Concentrations | Anti-D (Pre-Booster) | 0.134 IU/mL |
| HibACPS GROUP | Anti-D Antibody Concentrations | Anti-D (Post-Booster) | 5.297 IU/mL |
| HibHibPS GROUP | Anti-D Antibody Concentrations | Anti-D (Post-Booster) | 5.777 IU/mL |
| HibHibPS GROUP | Anti-D Antibody Concentrations | Anti-D (Pre-Booster) | 0.124 IU/mL |
| CC GROUP | Anti-D Antibody Concentrations | Anti-D (Pre-Booster) | 0.168 IU/mL |
| CC GROUP | Anti-D Antibody Concentrations | Anti-D (Post-Booster) | 9.269 IU/mL |
Secondary
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Post-Booster) | 3451.8 mIU/ml |
| ACAC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Pre-Booster) | 54.8 mIU/ml |
| CC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Pre-Booster) | 91.2 mIU/ml |
| CC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Post-Booster) | 7801.4 mIU/ml |
| HibACPS GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Post-Booster) | 6547.7 mIU/ml |
| HibACPS GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Pre-Booster) | 95.0 mIU/ml |
| HibHibPS GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Pre-Booster) | 84.4 mIU/ml |
| HibHibPS GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Post-Booster) | 7265.8 mIU/ml |
| CC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Post-Booster) | 3334.0 mIU/ml |
| CC GROUP | Anti-HBs Antibody Concentrations | Anti-HBs (Pre-Booster) | 65.6 mIU/ml |
Secondary
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Pre-Booster) | 4.572 μg/mL |
| ACAC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Post-Booster) | 85.798 μg/mL |
| CC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Pre-Booster) | 4.371 μg/mL |
| CC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Post-Booster) | 168.232 μg/mL |
| HibACPS GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Pre-Booster) | 3.728 μg/mL |
| HibACPS GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Post-Booster) | 56.772 μg/mL |
| HibHibPS GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Post-Booster) | 129.222 μg/mL |
| HibHibPS GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Pre-Booster) | 4.498 μg/mL |
| CC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Pre-Booster) | 4.775 μg/mL |
| CC GROUP | Anti-PRP Antibody Concentrations | Anti-PRP (Post-Booster) | 115.384 μg/mL |
Secondary
Anti-PSA Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) ad expressed in micrograms per milliliter ().
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Pre-Booster) | 0.64 µg/ml |
| ACAC GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Post-Booster) | 20.31 µg/ml |
| CC GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Pre-Booster) | 0.20 µg/ml |
| CC GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Post-Booster) | 14.20 µg/ml |
| HibACPS GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Pre-Booster) | 0.17 µg/ml |
| HibACPS GROUP | Anti-PSA Antibody Concentrations | Anti-PSA (Post-Booster) | 0.19 µg/ml |
Secondary
Anti-PSC Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in micrograms/milliliter (µg/ml).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Pre-Booster) | 1.37 µg/ml |
| ACAC GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Post-Booster) | 11.71 µg/ml |
| CC GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Pre-Booster) | 0.16 µg/ml |
| CC GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Post-Booster) | 25.96 µg/ml |
| HibACPS GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Pre-Booster) | 1.41 µg/ml |
| HibACPS GROUP | Anti-PSC Antibody Concentrations | Anti-PSC (Post-Booster) | 31.42 µg/ml |
Secondary
Anti-rSBA-MenA Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Pre-Booster | 626.2 Titers |
| ACAC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Post-Booster | 1488.8 Titers |
| ACAC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Pre-Booster | 141.1 Titers |
| ACAC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Post-Booster | 1784.8 Titers |
| CC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Post-Booster | 1663.7 Titers |
| CC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Pre-Booster | 327.2 Titers |
| CC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Pre-Booster | 37.1 Titers |
| CC GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Post-Booster | 3429.6 Titers |
| HibACPS GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Post-Booster | 172.5 Titers |
| HibACPS GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Post-Booster | 411.5 Titers |
| HibACPS GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L10), Pre-Booster | 33.8 Titers |
| HibACPS GROUP | Anti-rSBA-MenA Antibody Titers | rSBA-MenA (L11), Pre-Booster | 468.3 Titers |
Secondary
Anti-SBA-MenC Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Pre-Booster) | 295.2 Titers |
| ACAC GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Post-Booster) | 4891.2 Titers |
| CC GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Pre-Booster) | 6.3 Titers |
| CC GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Post-Booster) | 1868.4 Titers |
| HibACPS GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Pre-Booster) | 143.8 Titers |
| HibACPS GROUP | Anti-SBA-MenC Antibody Titers | Anti-SBA-MenC (Post-Booster) | 8068.6 Titers |
Secondary
Anti-TT Antibody Concentrations
Antibody concentrations were presented as Geometric Mean Concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Pre-Booster) | 0.709 IU/mL |
| ACAC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Post-Booster) | 16.313 IU/mL |
| CC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Pre-Booster) | 0.648 IU/mL |
| CC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Post-Booster) | 18.942 IU/mL |
| HibACPS GROUP | Anti-TT Antibody Concentrations | Anti-TT (Pre-Booster) | 0.617 IU/mL |
| HibACPS GROUP | Anti-TT Antibody Concentrations | Anti-TT (Post-Booster) | 12.531 IU/mL |
| HibHibPS GROUP | Anti-TT Antibody Concentrations | Anti-TT (Post-Booster) | 13.125 IU/mL |
| HibHibPS GROUP | Anti-TT Antibody Concentrations | Anti-TT (Pre-Booster) | 0.537 IU/mL |
| CC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Pre-Booster) | 0.566 IU/mL |
| CC GROUP | Anti-TT Antibody Concentrations | Anti-TT (Post-Booster) | 10.792 IU/mL |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 4-day (Day 0 to Day 3) post-vaccination period
Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 206 Participants |
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 55 Participants |
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 142 Participants |
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 5 Participants |
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 114 Participants |
| ACAC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 48 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 90 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 68 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 18 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 38 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 61 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 44 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 15 Participants |
| HibACPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 2 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 6 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 19 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 20 Participants |
| HibHibPS GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 31 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 51 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 55 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 22 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 4 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 5 Participants |
| CC GROUP | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 87 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 6 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 21 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 159 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 198 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 198 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 133 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 133 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 159 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 14 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 130 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| ACAC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 130 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 56 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 89 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 2 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 54 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 71 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 6 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 71 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 3 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 56 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 89 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 54 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 3 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 7 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 46 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 1 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 46 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 58 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 4 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 58 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 32 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 32 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 43 Participants |
| HibACPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 43 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 29 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 24 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 2 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 19 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 29 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 20 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 20 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 24 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 4 Participants |
| HibHibPS GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 19 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 79 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 55 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 58 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 2 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 4 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 79 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 55 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 8 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 57 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 57 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 58 Participants |
| CC GROUP | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 11 Participants |
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 (Days 0-30) post-vaccination period
Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACAC GROUP | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 7 Participants |
| CC GROUP | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 4 Participants |
| HibACPS GROUP | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 0 Participants |
| HibHibPS GROUP | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 2 Participants |
| CC GROUP | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 8 Participants |
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: Up to one month Post-Booster vaccination
Population: The Booster Total Vaccinated cohort included all subjects vaccinated during the Booster stage.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ACAC GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 8 Participants |
| CC GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| HibACPS GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| HibHibPS GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| CC GROUP | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 15 ELISA units per milliliter (EL.U/mL).
Time frame: One month Post-Booster vaccination
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | 98.2 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | 100 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | 100 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | 97.4 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value | 99.1 Percentage |
Secondary
Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.1 international units per milliliter (IU/mL) as assessed by enzyme-linked immunosorbent assay (ELISA) or ≥ 0.016 IU/ml as assessed by Vero cell neutralization test if concentrations were \< 0.1 IU/ml when assessed by ELISA.
Time frame: One month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after the booster vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | 99.2 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | 100 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | 100 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | 100 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values | 100 Percentage |
Secondary
Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value
Antibody concentrations cut-off value was ≥ 10 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Pre-Booster) | 82.6 Percentage |
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Post-Booster) | 95.8 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Pre-Booster) | 90.8 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Post-Booster) | 97.5 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Pre-Booster) | 94.7 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Post-Booster) | 98.7 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Post-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Pre-Booster) | 90.2 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Pre-Booster) | 81.6 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value | Anti-HBs (Post-Booster) | 96.6 Percentage |
Secondary
Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off value was ≥ 0.1 international units per milliliter (IU/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence, for whom data concerning the immunogenicity measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component pre/after the booster vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Pre-Booster) | 99.2 Percentage |
| ACAC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Pre-Booster) | 99.2 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Pre-Booster) | 97.4 Percentage |
| HibACPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Post-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Post-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Pre-Booster) | 97.6 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Pre-Booster) | 96.6 Percentage |
| CC GROUP | Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values | Anti-TT (Post-Booster) | 100 Percentage |
Secondary
Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.15 and ≥ 1 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster According-to-Protocol (ATP) cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Pre-Booster) | 100 Percentage |
| ACAC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Post-Booster) | 100 Percentage |
| ACAC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Pre-Booster) | 88.3 Percentage |
| ACAC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Pre-Booster) | 99.2 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Pre-Booster) | 86.1 Percentage |
| HibACPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Pre-Booster) | 88.2 Percentage |
| HibACPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Pre-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Pre-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Post-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Post-Booster) | 100 Percentage |
| HibHibPS GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Pre-Booster) | 87.8 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 1 µg/mL (Pre-Booster) | 89.3 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values | Anti-PRP ≥ 0.15 µg/mL (Pre-Booster) | 99.2 Percentage |
Secondary
Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Pre-Booster) | 78.9 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Post-Booster) | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Pre-Booster) | 12.6 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Post-Booster) | 97.6 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Pre-Booster) | 18.4 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Pre-Booster) | 2.6 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Post-Booster) | 0.0 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Post-Booster) | 15.0 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 2 µg/ml (Pre-Booster) | 2.4 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSA ≥ 0.3 µg/ml (Pre-Booster) | 7.3 Percentage |
Secondary
Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values
Antibody concentrations cut-off values were ≥ 0.3 and ≥ 2 micrograms per milliliter (µg/mL).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 97.2 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Post-Booster) | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 33.6 Percentage |
| ACAC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Post-Booster) | 99.2 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 3.9 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 1.3 Percentage |
| CC GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 2 µg/mL (Pre-Booster) | 30.3 Percentage |
| HibACPS GROUP | Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values | Anti-PSC ≥ 0.3 µg/mL (Pre-Booster) | 97.5 Percentage |
Secondary
Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenC conjugate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Pre-Booster) | 95.1 Percentage |
| ACAC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Post-Booster) | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:128 (Pre-Booster) | 82.1 Percentage |
| ACAC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥1:128 (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥1:128 (Post-Booster) | 100 Percentage |
| CC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Pre-Booster) | 10.7 Percentage |
| CC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:128 (Pre-Booster) | 8.0 Percentage |
| CC GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥1:128 (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Post-Booster) | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:128 (Pre-Booster) | 61.3 Percentage |
| HibACPS GROUP | Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values | Anti-SBA-MENC ≥ 1:8 (Pre-Booster) | 90.8 Percentage |
Secondary
Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:8 and (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Time frame: Prior to (PRE) and one month after (POST) the Booster vaccination at 15-24 months of age
Population: The Booster ATP cohort for Immunogenicity included all evaluable subjects from the Booster ATP cohort for Persistence and for whom data concerning the immunogenicity measures were available. This analysis focused only on subjects from groups boosted with a vaccine containing a MenA conjugate.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Pre-Booster | 99.6 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Post-Booster | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:128 Pre-Booster | 96.9 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥1:128 Post-Booster | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Pre-Booster | 88.8 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Post-Booster | 100 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Pre-Booster | 66.1 Percentage |
| ACAC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Post-Booster | 100 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:128 Pre-Booster | 85.7 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Pre-Booster | 42.4 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥1:128 Post-Booster | 100 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Pre-Booster | 54.2 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Post-Booster | 100 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Pre-Booster | 88.6 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Post-Booster | 100 Percentage |
| CC GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Post-Booster | 100 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:128 Pre-Booster | 94.1 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Post-Booster | 97.4 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥ 1:8 Pre-Booster | 94.1 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L11) ≥1:128 Post-Booster | 97.4 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Pre-Booster | 42.4 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Post-Booster | 90.0 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:8 Pre-Booster | 57.6 Percentage |
| HibACPS GROUP | Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values | rSBA-MenA (L10) ≥ 1:128 Post-Booster | 70.0 Percentage |