Infections, Meningococcal
Conditions
Keywords
Meningococcal disease, Toddlers, Neisseria meningitidis, Meningococcal vaccines, Immunogenicity, Human serum bactericidal assay, Safety, Vaccines, conjugate, Booster vaccination
Brief summary
The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Detailed description
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone. Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study. The protocol posting has been updated following a protocol amendment.
Interventions
BIOLOGICALGSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection
BIOLOGICALGSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
One dose in the booster phase as intramuscular injection
BIOLOGICALInfanrix®
One dose as intramuscular injection
BIOLOGICALActHIB®
Three doses in the priming phase as intramuscular injection
BIOLOGICALPediarix®
Three doses in the priming phase as intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after 36 weeks gestation. * For inclusion in the booster phase, subjects must have received all three doses in the primary phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | One month post vaccination at 12-15 months of age (Month 11) | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 |
| Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | One month post vaccination at 15-18 months of age (Month 14) | The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group | One month post vaccination at 12-15 months of age (Month 11) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | One month post vaccination at 15-18 months of age (Month 14) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | One month post vaccination at 15-18 months of age (Month 14) | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group | One month post vaccination at 12-15 months of age (Month 11) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group | One month post vaccination at 12-15 months of age (Month 11) | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8 |
| Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | One month after vaccination at 15-18 months of age (Month 14) | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | One month after vaccination at 15-18 months of age (Month 14) | Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | One month after vaccination at 15-18 months of age (Month 14) | The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL). |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | One month after vaccination at 15-18 months of age (Month 14) | The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4 |
| Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group | One month after vaccination with Infanrix at 15-18 months of age (Month 14) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (\>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination | Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature \> 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | One month after vaccination at 12-15 months of age (Month 11) | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase | Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was \> 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. |
| Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) | NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | During a 31-day follow-up period (Day 0-30) | Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination | During the 31-day follow-up period (Day 0-30) | Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13). | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any Rash | From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22) | Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae. |
| Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group | One month after vaccination at 12-15 months of age (Month 11) | The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4 |
| Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group | One month after vaccination at 12-15 months of age (Month 11) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | Prior to vaccination at 15-18 months of age (Month 13) | Antibody titers were expressed as Geometric mean titers (GMTs) |
| Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | Prior to vaccination at 15-18 months of age (Month 13) | The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8 |
| Anti-D and Anti-T Geometric Mean Antibody Concentrations | One month after vaccination with Infanrix at 15-18 months of age (Month 14) | Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL). |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | One month after vaccination with Infanrix at 15-18 months of age (Month 14) | The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL). |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | One month after vaccination with Infanrix at 15-18 months of age (Month 14) | The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) |
Countries
United States
Participant flow
Pre-assignment details
A total of 1558 subjects (1276 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were enrolled; however, 4 of these subjects never received vaccine. Thus, 1554 subjects (1272 in the Menhibrix 1 Group and 282 in ActHIB- Infanrix Group) were vaccinated during primary vaccination phase.
Participants by arm
| Arm | Count |
|---|---|
| Menhibrix 1 Group Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase. | 1,272 |
| ActHIB- Infanrix Group Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase. | 282 |
| Total | 1,554 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Booster Vaccination Phase | Adverse Event | 0 | 0 | 1 | 1 | 0 |
| Booster Vaccination Phase | Lost to Follow-up | 0 | 5 | 17 | 10 | 8 |
| Booster Vaccination Phase | Other | 0 | 1 | 3 | 2 | 1 |
| Booster Vaccination Phase | Protocol Violation | 0 | 0 | 2 | 3 | 0 |
| Booster Vaccination Phase | Withdrawal by Subject | 0 | 0 | 4 | 3 | 4 |
| Primary Vaccination Phase | Adverse Event | 6 | 0 | 0 | 0 | 0 |
| Primary Vaccination Phase | Lost to Follow-up | 26 | 8 | 0 | 0 | 0 |
| Primary Vaccination Phase | Other | 4 | 0 | 0 | 0 | 0 |
| Primary Vaccination Phase | Protocol Violation | 9 | 3 | 0 | 0 | 0 |
| Primary Vaccination Phase | Withdrawal by Subject | 45 | 6 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | ActHIB- Infanrix Group | Total | Menhibrix 1 Group |
|---|---|---|---|
| Age, Continuous | 8.7 Weeks STANDARD_DEVIATION 1.25 | 8.6 Weeks STANDARD_DEVIATION 1.25 | 8.6 Weeks STANDARD_DEVIATION 1.25 |
| Race/Ethnicity, Customized African heritage / African American | 20 Participants | 155 Participants | 135 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan native | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian heritage | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - East Asian heritage | 1 Participants | 5 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian - Japanese heritage | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - South East Asian heritage | 2 Participants | 10 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unspecified | 32 Participants | 159 Participants | 127 Participants |
| Race/Ethnicity, Customized White - Arabic / North African heritage | 3 Participants | 17 Participants | 14 Participants |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 223 Participants | 1197 Participants | 974 Participants |
| Sex: Female, Male Female | 150 Participants | 756 Participants | 606 Participants |
| Sex: Female, Male Male | 132 Participants | 798 Participants | 666 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 | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 181 / 233 | 387 / 432 | 211 / 229 | 337 / 409 |
| serious Total, serious adverse events | 58 / 1,272 | 14 / 282 | 15 / 432 | 3 / 229 | 9 / 409 |
Outcome results
Primary
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on Nimenrix 2 and ActHIB- Infanrix Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ActHIB- Infanrix Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-PT | 91.0 EL.U/mL |
| ActHIB- Infanrix Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-FHA | 422.9 EL.U/mL |
| ActHIB- Infanrix Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-PRN | 315.1 EL.U/mL |
| Nimenrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-PT | 67.7 EL.U/mL |
| Nimenrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-FHA | 353.2 EL.U/mL |
| Nimenrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-PRN | 189.2 EL.U/mL |
Primary
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Menhibrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group | hSBA-MenC | 2676.1 titer |
| Menhibrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group | hSBA-MenY | 2227.7 titer |
Primary
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group | hSBA-MenC | 3845.0 titer |
| Nimenrix 1 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group | hSBA-MenY | 4800.9 titer |
Primary
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: One month post vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | hSBA-MenC | 7230.5 titer |
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | hSBA-MenY | 7487.6 titer |
Primary
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Time frame: One month post vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. It was performed on the Nimenrix 2 and ActHIB- Infanrix Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-D | 146 Participants |
| ActHIB- Infanrix Group | Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-T | 145 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-D | 253 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group | Anti-T | 253 Participants |
Primary
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Time frame: One month post vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | hSBA-MenA | 248 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | hSBA-MenC | 293 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | hSBA-MenW-135 | 279 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group | hSBA-MenY | 303 Participants |
Primary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Menhibrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Menhibrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group | hSBA-MenC | 155 Participants |
| Menhibrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group | hSBA-MenY | 157 Participants |
Primary
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Time frame: One month post vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | hSBA-MenA | 254 Participants |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | hSBA-MenC | 286 Participants |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | hSBA-MenW-135 | 270 Participants |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group | hSBA-MenY | 291 Participants |
Secondary
Anti-D and Anti-T Geometric Mean Antibody Concentrations
Concentrations were provided as Geometric Mean Concentrations(GMCs) and expressed as International Units per milliliter (IU/mL).
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ActHIB- Infanrix Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-D | 8.259 IU/mL |
| ActHIB- Infanrix Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-T | 5.500 IU/mL |
| Nimenrix 1 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-T | 7.400 IU/mL |
| Nimenrix 1 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-D | 7.214 IU/mL |
| Menhibrix 2 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-D | 7.360 IU/mL |
| Menhibrix 2 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-T | 8.458 IU/mL |
| Nimenrix 2 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-D | 7.458 IU/mL |
| Nimenrix 2 Group | Anti-D and Anti-T Geometric Mean Antibody Concentrations | Anti-T | 11.751 IU/mL |
Secondary
Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-PT | 73.3 EL.U/mL |
| Nimenrix 1 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-FHA | 321.6 EL.U/mL |
| Nimenrix 1 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-PRN | 203.8 EL.U/mL |
| Menhibrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-PT | 86.9 EL.U/mL |
| Menhibrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-FHA | 371.7 EL.U/mL |
| Menhibrix 2 Group | Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group | Anti-PRN | 220.2 EL.U/mL |
Secondary
Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group | hSBA-MenA | 94.8 titer |
| Nimenrix 1 Group | Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group | hSBA-MenW-135 | 923.9 titer |
Secondary
Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group | hSBA-MenA | 92.4 titer |
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group | hSBA-MenW-135 | 1582.9 titer |
Secondary
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
Antibody titers were expressed as Geometric mean titers (GMTs)
Time frame: Prior to vaccination at 15-18 months of age (Month 13)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | hSBA-Men C | 67.6 titer |
| Nimenrix 2 Group | Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group | hSBA-MenY | 142.3 titer |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was greater than (\>) 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Time frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any pain | 156 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 pain | 7 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any redness | 171 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 redness | 3 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any swelling | 97 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 swelling | 3 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 swelling | 1 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any pain | 104 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 redness | 1 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any swelling | 54 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 pain | 4 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any redness | 90 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 pain | 2 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any redness | 169 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 swelling | 3 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Grade 3 redness | 5 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any pain | 170 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine | Any swelling | 105 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine
Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 redness and swelling was \> 30 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful.
Time frame: During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any pain | 99 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 pain | 4 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any redness | 121 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 redness | 4 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any swelling | 80 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 swelling | 5 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 swelling | 6 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 redness | 9 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any pain | 145 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any redness | 175 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 pain | 5 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any swelling | 114 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 pain | 2 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any redness | 102 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 redness | 5 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 swelling | 5 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any swelling | 73 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any pain | 99 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any swelling | 113 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 swelling | 2 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 pain | 4 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Grade 3 redness | 2 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any pain | 156 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine | Any redness | 171 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 2 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 15 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 3 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 9 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13).
Population: The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 58 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 1 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAE(s) | 14 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase
Any fever was defined as axillary temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 fever was axillary temperature \> 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase and had symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose4 | 14 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 loss of appetite, Dose4 | 3 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 4 | 7 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 fever, Dose 4 | 0 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 4 | 1 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of apetite, Dose4 | 42 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose4 | 55 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose4 | 90 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 4 | 62 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 4 | 79 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 irritability, Dose 4 | 7 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 4 | 114 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 4 | 148 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 4 | 171 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 4 | 7 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose4 | 46 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 fever, Dose 4 | 2 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 4 | 32 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 4 | 230 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 irritability, Dose 4 | 13 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose4 | 202 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose4 | 144 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 loss of appetite, Dose4 | 7 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of apetite, Dose4 | 115 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 5 | 132 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 5 | 7 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 5 | 114 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose 5 | 34 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 fever, Dose 5 | 0 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 5 | 23 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 5 | 195 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 irritabiity, Dose 5 | 12 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose 5 | 171 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose 5 | 117 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 loss of appetite, Dose 5 | 2 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of appetite, Dose 5 | 86 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 4 | 6 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 fever, Dose 5 | 0 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose4 | 73 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose 5 | 62 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 fever, Dose 4 | 2 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose4 | 23 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 5 | 60 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 4 | 16 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 irritabiity, Dose 5 | 8 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 4 | 128 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 4 | 80 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose 5 | 16 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 irritability, Dose 4 | 11 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of appetite, Dose 5 | 53 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose4 | 106 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose 5 | 99 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 loss of appetite, Dose4 | 5 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 4 | 97 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 5 | 12 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of apetite, Dose4 | 55 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade 3 loss of appetite, Dose 5 | 5 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 5 | 67 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 5 | 103 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 5 | 6 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any loss of appetite, Dose4 | 138 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any drowsiness, Dose 4 | 161 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related fever, Dose 4 | 23 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any fever, Dose4 | 37 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 loss of appetite, Dose4 | 7 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related drowsiness, Dose 4 | 132 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 drowsiness, Dose 4 | 8 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 fever, Dose 4 | 1 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related loss of apetite, Dose4 | 105 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Related irritability, Dose4 | 188 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Any irritability, Dose 4 | 218 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase | Grade3 irritability, Dose 4 | 12 Participants |
Secondary
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 13 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 29 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 73 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 19 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 11 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 49 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 18 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 76 Participants |
Secondary
Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits
NOCIs include autoimmune disorders, asthma, type I diabetes and allergies. AEs prompting emergency room visits or physician visits are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13)
Population: The analysis was performed on Primary Total Vaccinated cohort which included all subjects who had received a study vaccine during the primary phase.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 128 Participants |
| ActHIB- Infanrix Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 293 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any NOCI(s) | 29 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits | Any ER visit(s) | 55 Participants |
Secondary
Number of Subjects Reporting Any Rash
Examples of rash included hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22)
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any Rash | 40 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any Rash | 93 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any Rash | 54 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any Rash | 83 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During a 31-day follow-up period (Day 0-30)
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | 101 Participants |
| Nimenrix 1 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | 194 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | 105 Participants |
| Nimenrix 2 Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination | 182 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: During the 31-day follow-up period (Day 0-30)
Population: The analysis was performed on Booster Total Vaccinated cohort which included all subjects who had received a study vaccine during the booster phase. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination | 167 Participants |
| Menhibrix 2 Group | Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination | 79 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 0.1 International Units per milliliter (IU/mL).
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-D | 146 Participants |
| ActHIB- Infanrix Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-T | 146 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-T | 252 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-D | 252 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-D | 132 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-T | 132 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-D | 254 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-T | 253 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group
The cut-off values assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | Anti-D | 250 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | Anti-T | 250 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | Anti-D | 132 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group | Anti-T | 132 Participants |
Secondary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value
The cut-off values assessed were greater than or equal to (≥) 5 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Time frame: One month after vaccination with Infanrix at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ActHIB- Infanrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PRN | 146 Participants |
| ActHIB- Infanrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PT | 146 Participants |
| ActHIB- Infanrix Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-FHA | 146 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PRN | 251 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-FHA | 252 Participants |
| Nimenrix 1 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PT | 252 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PT | 130 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-FHA | 132 Participants |
| Menhibrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PRN | 132 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PRN | 253 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-PT | 254 Participants |
| Nimenrix 2 Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value | Anti-FHA | 253 Participants |
Secondary
Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group
The cut-off values assessed for hSBA-MenA and hSBA-MenW-135 were greater than or equal to (≥) 1:4
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 1 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group | hSBA-MenA | 256 Participants |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group | hSBA-MenW-135 | 270 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY were greater than or equal to (≥) 1:4
Time frame: One month after vaccination at 15-18 months of age (Month 14)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenA | 253 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenC | 293 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenW-135 | 279 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenY | 303 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4
Time frame: One month after vaccination at 12-15 months of age (Month 11)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was performed on the Nimenrix 1 and Menhibrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | hSBA-MenC | 286 Participants |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | hSBA-MenY | 291 Participants |
| Menhibrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | hSBA-MenC | 155 Participants |
| Menhibrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group | hSBA-MenY | 157 Participants |
Secondary
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:4 and ≥ 1:8
Time frame: Prior to vaccination at 15-18 months of age (Month 13)
Population: Analysis was performed on Booster According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available against at least one study vaccine antigen component during booster phase vaccination. Analysis was only performed on the Nimenrix 2 Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenC ≥ 1:4 | 243 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenC ≥ 1:8 | 241 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenY ≥ 1:4 | 258 Participants |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group | hSBA-MenY ≥ 1:8 | 258 Participants |