Meningococcal Vaccine
Conditions
Brief summary
This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants \<6 months of age, followed by the booster at 12 months
Interventions
BIOLOGICALNimenrix
MenACWY-TT vaccine
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
76 Days to 104 Days
Healthy volunteers
Yes
Inclusion criteria
* Male or female infants born at \>36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1). * Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures. * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. * Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation. * Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.
Exclusion criteria
* Previous anaphylactic reaction to any vaccine or vaccine-related component. * Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. * History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. * Significant neurological disorder or history of seizure (including simple febrile seizure). * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * Other medical or psychiatric condition, including recent or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Major known congenital malformation or serious chronic disorder. * Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Within 7 days after vaccination 2 | Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Within 7 days after vaccination 2 | Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees (deg) Celsius (C), categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. |
| Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2 | Within 7 days after vaccination 2 | The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2 | Within 30 days after vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2 | Within 30 days after vaccination 2 | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2 | Within 30 days after vaccination 2 | An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2 | Within 30 minutes after vaccination 2 | Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1) | Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP). |
| Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | 1 month after vaccination 1 | Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At vaccination 2 | Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | 1 month after vaccination 2 | Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1) | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). |
| GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | 1 month after vaccination 1 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). |
| GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At vaccination 2 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). |
| GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | 1 month after vaccination 2 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Within 7 days after vaccination 1 | Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | Percentage of participants achieving rSBA Titers \>= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in Participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Within 7 days after vaccination 1 | Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded in e-diary. Fever was defined as temperature \>=38.0 deg C, categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method. |
| Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1 | Within 7 days after vaccination 1 | The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With AEs Within 30 Days After Vaccination 1 | Within 30 days after vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1 | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1 | Within 30 minutes after vaccination 1 | Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on post-dose 1 (PD1) evaluable immunogenicity population (EIP). |
| Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | Percentage of participants achieving rSBA titer \>= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution). |
| Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | Percentage of participants achieving hSBA titers \>= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | Percentage of participants achieving hSBA titers \>= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | At baseline (before vaccination 1) and 1 month after vaccination 1 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution). |
| Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | Percentage of participants achieving hSBA titers \>= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | Percentage of participants achieving hSBA titers \>= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. |
| GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution). |
Countries
Finland, Poland, Spain
Participant flow
Pre-assignment details
Total of 153 participants were screened, of which 4 were screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Participants aged 3 months were administered a single dose of 0.5 milliliter (mL) Nimenrix (Vaccination 1) intramuscularly into the left thigh muscle on Day 1 (Visit 1) and a second dose of Nimenrix (Vaccination 2) at 12 months of age (Visit 3). Participants had a safety follow-up visit 1 month after each vaccination (Visit 2 and Visit 4 respectively). | 145 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by parent/guardian | 3 |
| Overall Study | Withdrawn before vaccination | 2 |
Baseline characteristics
| Characteristic | Nimenrix |
|---|---|
| Age, Continuous | 94.4 Days STANDARD_DEVIATION 6.09 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 141 Participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 145 |
| other Total, other adverse events | 139 / 145 |
| serious Total, serious adverse events | 10 / 145 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Time frame: At baseline (before vaccination 1)
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenA | 4.0 Titer |
| Nimenrix | Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenC | 4.4 Titer |
| Nimenrix | Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 4.1 Titer |
| Nimenrix | Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenY | 5.0 Titer |
Primary
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Time frame: 1 month after vaccination 1
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenA | 54.7 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenC | 107.6 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 202.4 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenY | 187.2 Titer |
Primary
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Time frame: 1 month after vaccination 2
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA | 1818.0 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC | 1299.5 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 2714.1 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY | 1667.1 Titer |
Primary
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Time frame: At vaccination 2
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA | 9.9 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC | 21.8 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 21.7 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY | 24.5 Titer |
Primary
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: 1 month after vaccination 1
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenA | 82.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenC | 91.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 89.5 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population | MenY | 90.3 Percentage of participants |
Primary
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: 1 month after vaccination 2
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY | 100.0 Percentage of participants |
Primary
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At vaccination 2
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA | 33.6 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC | 64.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 67.2 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY | 66.4 Percentage of participants |
Primary
Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP).
Time frame: At baseline (before vaccination 1)
Population: PD2 EIP: participants enrolled and eligible through 1 month after vaccination 2; received vaccine at visit (V) 1 and V3; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and at 1 month after dose 2 (V4: window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, and MenY assay result at V4, received no prohibited vaccines/treatment and had no protocol deviations through V4. Here, N =participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenA | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenC | 4.7 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenW-135 | 0.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population | MenY | 7.8 Percentage of participants |
Primary
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: Within 30 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2 | 19.6 Percentage of participants | 95% Confidence Interval 13.4 |
Primary
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 30 minutes after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2 | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Mild | 14.1 Percentage of participants | 95% Confidence Interval 8.8 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Mild | 19.7 Percentage of participants | 95% Confidence Interval 13.5 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Moderate | 7.7 Percentage of participants | 95% Confidence Interval 3.9 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Pain at injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Moderate | 2.8 Percentage of participants | 95% Confidence Interval 0.8 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Mild | 4.9 Percentage of participants | 95% Confidence Interval 2 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2
An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 30 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2 | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 30 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2 | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (\>=) 38.0 degrees (deg) Celsius (C), categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Time frame: Within 7 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Moderate | 42.3 Percentage of participants | 95% Confidence Interval 34 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >=38.0 deg C to 38.4 deg C | 6.3 Percentage of participants | 95% Confidence Interval 2.9 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.4 deg C to 38.9 deg C | 4.9 Percentage of participants | 95% Confidence Interval 2 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >38.9 deg C to 40.0 deg C | 3.5 Percentage of participants | 95% Confidence Interval 1.2 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Fever: >40.0 deg C | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Mild | 19.7 Percentage of participants | 95% Confidence Interval 13.5 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Moderate | 11.3 Percentage of participants | 95% Confidence Interval 6.6 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Decreased appetite: Severe | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Increased sleep: Mild | 38.0 Percentage of participants | 95% Confidence Interval 30 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Increased sleep: Moderate | 11.3 Percentage of participants | 95% Confidence Interval 6.6 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Increased sleep: Severe | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Mild | 18.3 Percentage of participants | 95% Confidence Interval 12.3 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Irritability: Severe | 2.8 Percentage of participants | 95% Confidence Interval 0.8 |
Primary
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination 2
Population: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2 | 55.6 Percentage of participants | 95% Confidence Interval 47.1 |
Secondary
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution).
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Population: PD2 EIP:participants enrolled \& eligible through 1 month after vaccination2; received vaccine at visit (V) 1 \& V3;blood drawn for assay testing within time frames at Month0 (V1; before dose 1) \& at 1 month after dose2 (V4: window 28-42 days);at least 1 valid,determinate MenA, MenC, MenW-135, \& MenY assay result at V4,received no prohibited vaccines/treatment \& had no protocol deviation through V4.Here,N=participants evaluable for this outcome measure \& n=participant evaluable for specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 2.4 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 86.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 2) | 9.5 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 2 | 1208.4 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 2.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 149.8 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 2) | 74.8 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 2 | 7299.6 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 2.8 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 8.8 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 2) | 121.6 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 2 | 6955.8 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 5.7 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 19.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 2) | 45.7 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 2 | 5062.1 Titer |
Secondary
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution).
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP:participants enrolled \& eligible through V2;received vaccine at V1;blood drawn for assay testing within time frames at Month 0 (V1; before dose1) \& Month1 (V2;1 month after dose1:window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 \& MenY assay result at V2, received no prohibited vaccines/treatment \& had no protocol deviation through V2.N=signifies participants evaluable for this outcome measure.'Number Analyzed' signifies participants evaluable for specified row.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 19.2 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 2.4 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 82.0 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 2.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 128.4 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 2.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 6.9 Titer |
| Nimenrix | GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 6.6 Titer |
Secondary
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP: participants enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and Month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 4.0 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 50.1 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 4.3 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 96.7 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 4.1 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 193.3 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 4.8 Titer |
| Nimenrix | GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 172.6 Titer |
Secondary
Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers \>= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Population: PD2 EIP:participant enrolled \& eligible through 1month after vaccination2;received vaccine at V1 \&V3;blood drawn for assay testing within time frame at Month0 (V1;before dose1) \& at 1 month after dose2 (V4:window 28-42 days); at least 1 valid, determinate MenA, MenC, MenW-135, \& MenY assay result at V4, received no prohibited vaccine/treatment \& had no protocol deviation through V4.Here,N=participant evaluable for outcome measure.'Number Analyzed' signify participant evaluable for specified row
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 12.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 11.7 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 93.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Before Vaccination 2 | 85.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 38.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Before Vaccination 2 | 94.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 21.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 50.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Before Vaccination 2 | 70.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 8.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 95.5 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Before Vaccination 2 | 49.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
Secondary
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers \>= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Population: PD2 EIP:participant enrolled \& eligible through 1month after vaccination2;received vaccine at visit 1,3;blood drawn for assay testing within time frames at Month0 (V1;before dose1) \& at 1month after dose2(V4:window 28-42 days);at least 1 valid,determinate MenA, MenC,MenW-135, \& MenY assay result at V4,received no prohibited vaccine/treatment \& had no protocol deviation through V4.Here,N=participant evaluable for outcome measure. 'Number Analyzed' signify participant evaluable for specified row.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 93.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 7.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 95.5 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 2) | 46.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 11.7 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 2) | 85.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 12.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 38.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 2) | 94.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 21.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 50.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 2) | 70.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
Secondary
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers \>= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP:participants enrolled \& eligible through V2;received vaccine at V1;blood drawn for assay testing within time frames at Month 0 (V1; before dose1) \& Month1 (V2;1 month after dose1:window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 \& MenY assay result at V2, received no prohibited vaccines/treatment \& had no protocol deviation through V2.N=signifies participants evaluable for this outcome measure.'Number Analyzed' signifies participants evaluable for specified row
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 6.5 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 94.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 13.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 91.6 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 13.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 33.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 25.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 48.5 Percentage of participants |
Secondary
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA Titers \>= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in Participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Population: PD2 EIP:participants enrolled \& eligible through 1 month after vaccination2; received vaccine at visit (V) 1 \& V3;blood drawn for assay testing within time frames at Month0 (V1; before dose 1) \& at 1 month after dose2 (V4: window 28-42 days);at least 1 valid,determinate MenA, MenC, MenW-135, \& MenY assay result at V4,received no prohibited vaccines/treatment \& had no protocol deviation through V4.Here,N=participants evaluable for this outcome measure \& n=participant evaluable for specified row
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 40.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, Before Vaccination 2 | 15.2 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 0.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 67.7 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, Before Vaccination 2 | 20.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 2 | 98.4 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 0.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 79.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, Before Vaccination 2 | 23.2 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 2 | 100.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 3.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 83.1 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, Before Vaccination 2 | 27.2 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 2 | 99.2 Percentage of participants |
Secondary
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP: participants enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and Month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 35.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 65.5 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 0.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 79.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 2.6 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 81.0 Percentage of participants |
Secondary
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer \>=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on post-dose 1 (PD1) evaluable immunogenicity population (EIP).
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP: participants enrolled and eligible through V2; received vaccine at V1; blood drawn for assay testing within time frames at Month 0 (V1; before dose 1) and Month 1 (V2; 1 month after dose 1: window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 and MenY assay result at V2, received no prohibited vaccines/treatment and had no protocol deviations through V2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 81.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 5.2 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 89.7 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 0.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 88.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 7.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 87.9 Percentage of participants |
Secondary
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers \>= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Population: PD1 EIP:participants enrolled \& eligible through V2;received vaccine at V1;blood drawn for assay testing within time frames at Month 0 (V1; before dose1) \& Month1 (V2;1 month after dose1:window 28-42 days); had at least 1 valid, determinate MenA, MenC, MenW-135 \& MenY assay result at V2, received no prohibited vaccines/treatment \& had no protocol deviation through V2.N=signifies participants evaluable for this outcome measure.'Number Analyzed' signifies participants evaluable for specified row
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, Baseline (Before Vaccination 1) | 7.6 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenA, 1 Month after Vaccination 1 | 94.3 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, Baseline (Before Vaccination 1) | 13.0 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenC, 1 Month after Vaccination 1 | 91.6 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, Baseline (Before Vaccination 1) | 13.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenW-135, 1 Month after Vaccination 1 | 33.9 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, Baseline (Before Vaccination 1) | 25.8 Percentage of participants |
| Nimenrix | Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population | MenY, 1 Month after Vaccination 1 | 48.5 Percentage of participants |
Secondary
Percentage of Participants With AEs Within 30 Days After Vaccination 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Time frame: Within 30 days after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With AEs Within 30 Days After Vaccination 1 | 6.9 Percentage of participants | 95% Confidence Interval 3.4 |
Secondary
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 30 minutes after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1 | 0.0 Percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: \>0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Mild | 13.8 Percentage of participants | 95% Confidence Interval 8.6 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Moderate | 2.8 Percentage of participants | 95% Confidence Interval 0.8 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Pain at injection site: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Mild | 6.2 Percentage of participants | 95% Confidence Interval 2.9 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Moderate | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Redness: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Mild | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Swelling: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | NDCMC:From 1 Month after Vaccination 1 to 9 Month after Vaccination 1 | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | SAE: Within 30 days after Vaccination 1 | 1.4 Percentage of participants |
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | SAE: From 1 Month after Vaccination 1 to 9 Month after Vaccination 1 | 4.1 Percentage of participants |
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | SAE: From Vaccination 1 to 9 Month after Vaccination 1 | 5.5 Percentage of participants |
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | NDCMC: Within 30 days after Vaccination 1 | 0.0 Percentage of participants |
| Nimenrix | Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1 | NDCMC: From Vaccination 1 to 9 Month after Vaccination 1 | 0.0 Percentage of participants |
Secondary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded in e-diary. Fever was defined as temperature \>=38.0 deg C, categorized as \>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C,\>38.9 to 40.0 deg C and \>40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Time frame: Within 7 days after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >=38.0 deg C to 38.4 deg C | 7.6 Percentage of participants | 95% Confidence Interval 3.8 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.4 deg C to 38.9 deg C | 2.1 Percentage of participants | 95% Confidence Interval 0.4 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >38.9 deg C to 40.0 deg C | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Fever: >40.0 deg C | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Mild | 15.2 Percentage of participants | 95% Confidence Interval 9.8 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Moderate | 8.3 Percentage of participants | 95% Confidence Interval 4.3 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Decreased appetite: Severe | 0 Percentage of participants | 95% Confidence Interval 0 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Increased sleep: Mild | 57.2 Percentage of participants | 95% Confidence Interval 48.8 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Increased sleep: Moderate | 7.6 Percentage of participants | 95% Confidence Interval 3.8 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Increased sleep: Severe | 1.4 Percentage of participants | 95% Confidence Interval 0.2 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Mild | 27.6 Percentage of participants | 95% Confidence Interval 20.5 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Moderate | 40.0 Percentage of participants | 95% Confidence Interval 32 |
| Nimenrix | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Irritability: Severe | 4.8 Percentage of participants | 95% Confidence Interval 2 |
Secondary
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination 1
Population: Dose 1 safety population included participants who received the first dose of investigational product at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Nimenrix | Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1 | 39.3 Percentage of participants | 95% Confidence Interval 31.3 |