| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| | | Title | Denominators | Categories |
|---|
| Pain at injection site: Mild | | | Title | Measurements |
|---|
| - OG00019.7± 13.5(13.5 to 27.2)
|
| | Pain at injection site: Moderate | | | Title | Measurements |
|---|
| - OG0007.7± 3.9(3.9 to 13.4)
|
| | Pain at injection site: Severe |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
|
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 minutes after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1) | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At baseline (before vaccination 1) | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | 1 month after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | 1 month after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 7 days after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 minutes after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
| |
| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | 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). |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At baseline (before vaccination 1) and 1 month after vaccination 1 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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 | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 | | | | ID | Title | Description |
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| OG000 | 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). |
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