Trial Outcomes & Findings for Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age (NCT NCT04819113)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

149 participants

Primary outcome timeframe

Within 7 days after vaccination 2

Results posted on

2024-03-18

Participant Flow

Total of 153 participants were screened, of which 4 were screen failures.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	149
Overall Study Vaccination 1	147
Overall Study Safety Population	145
Overall Study Vaccination 2	143
Overall Study COMPLETED	143
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Withdrawal by parent/guardian	3
Overall Study Lost to Follow-up	1
Overall Study Withdrawn before vaccination	2

Baseline Characteristics

Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nimenrix n=145 Participants 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).
Age, Continuous	94.4 Days STANDARD_DEVIATION 6.09 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	141 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=142 Participants 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).
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 • Interval 13.5 to 27.2
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 • Interval 3.9 to 13.4
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.6
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Redness: Mild	14.1 Percentage of participants 95% Confidence Interval 8.8 • Interval 8.8 to 20.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Redness: Moderate	2.8 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 7.1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.6
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Swelling: Mild	4.9 Percentage of participants 95% Confidence Interval 2.0 • Interval 2.0 to 9.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Swelling: Moderate	1.4 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 5.0
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=142 Participants 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).
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 • Interval 13.5 to 27.2
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 • Interval 0.2 to 5.0
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 • Interval 2.9 to 11.7
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 2.0 • Interval 2.0 to 9.9
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 • Interval 1.2 to 8.0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Fever: >40.0 deg C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.6
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 • Interval 6.6 to 17.7
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Increased sleep: Mild	38.0 Percentage of participants 95% Confidence Interval 30.0 • Interval 30.0 to 46.5
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 • Interval 6.6 to 17.7
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 • Interval 0.2 to 5.0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Irritability: Mild	18.3 Percentage of participants 95% Confidence Interval 12.3 • Interval 12.3 to 25.7
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Irritability: Moderate	42.3 Percentage of participants 95% Confidence Interval 34.0 • Interval 34.0 to 50.8
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 Irritability: Severe	2.8 Percentage of participants 95% Confidence Interval 0.8 • Interval 0.8 to 7.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=142 Participants 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).
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2	55.6 Percentage of participants 95% Confidence Interval 47.1 • Interval 47.1 to 64.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=143 Participants 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).
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2	19.6 Percentage of participants 95% Confidence Interval 13.4 • Interval 13.4 to 27.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=143 Participants 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).
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2	1.4 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 5.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=143 Participants 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).
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=143 Participants 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).
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2	0.0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nimenrix n=128 Participants 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).
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 Interval 0.0 to 2.8
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 Interval 1.7 to 9.9
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 Interval 0.0 to 4.3
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 Interval 3.8 to 13.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=124 Participants 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).
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 Interval 74.4 to 88.5
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 Interval 84.7 to 95.5
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 Interval 82.7 to 94.3
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 Interval 83.7 to 94.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=125 Participants 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).
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 Interval 25.4 to 42.6
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 Interval 55.8 to 73.1
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 Interval 58.2 to 75.3
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 Interval 57.4 to 74.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=128 Participants 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).
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 Interval 97.2 to 100.0
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 Interval 97.2 to 100.0
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 Interval 97.2 to 100.0
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 Interval 97.2 to 100.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nimenrix n=128 Participants 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).
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 Interval 4.0 to 4.0
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 Interval 4.0 to 4.7
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 Interval 3.9 to 4.3
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 Interval 4.3 to 5.8

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nimenrix n=124 Participants 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).
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 Interval 141.6 to 247.5
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 Interval 41.1 to 72.9
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 Interval 81.3 to 142.5
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 Interval 149.6 to 274.0

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nimenrix n=125 Participants 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).
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 Interval 16.3 to 28.9
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 Interval 18.0 to 33.4
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 Interval 7.6 to 13.0
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 Interval 16.1 to 29.5

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Nimenrix n=128 Participants 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).
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 Interval 2233.0 to 3298.8
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 Interval 1497.8 to 2206.6
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 Interval 1052.3 to 1604.9
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 Interval 1393.9 to 1993.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=145 Participants 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).
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 • Interval 8.6 to 20.5
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 • Interval 0.8 to 6.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Redness: Mild	6.2 Percentage of participants 95% Confidence Interval 2.9 • Interval 2.9 to 11.5
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Redness: Moderate	1.4 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 4.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Redness: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Swelling: Mild	1.4 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 4.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Swelling: Moderate	1.4 Percentage of participants 95% Confidence Interval 0.2 • Interval 0.2 to 4.9
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 Swelling: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=145 Participants 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).
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 • Interval 0.4 to 5.9
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 • Interval 3.8 to 13.2
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 0.0 • Interval 0.0 to 2.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Fever: >40.0 deg C	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5
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 • Interval 9.8 to 22.1
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 • Interval 4.3 to 14.0
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Decreased appetite: Severe	0 Percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 2.5
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 • Interval 48.8 to 65.4
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 • Interval 3.8 to 13.2
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 • Interval 0.2 to 4.9
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Irritability: Mild	27.6 Percentage of participants 95% Confidence Interval 20.5 • Interval 20.5 to 35.6
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Irritability: Moderate	40.0 Percentage of participants 95% Confidence Interval 32.0 • Interval 32.0 to 48.5
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 Irritability: Severe	4.8 Percentage of participants 95% Confidence Interval 2.0 • Interval 2.0 to 9.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=145 Participants 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).
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1	39.3 Percentage of participants 95% Confidence Interval 31.3 • Interval 31.3 to 47.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=145 Participants 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).
Percentage of Participants With AEs Within 30 Days After Vaccination 1	6.9 Percentage of participants 95% Confidence Interval 3.4 • Interval 3.4 to 12.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Nimenrix n=145 Participants 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).
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 Interval 0.2 to 4.9
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 Interval 1.5 to 8.8
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 Interval 2.4 to 10.6
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 Interval 0.0 to 2.5
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 Interval 0.0 to 2.5
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 Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 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.

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.