MenABCWY Noninferiority Study in Healthy Participants ≥10... | NCT04440163 | Trialant
NCT04440163
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 18, 2023Actual
Enrollment
2,431Actual
Phase
Phase 3
Conditions
Meningococcal Vaccine
Interventions
MenABCWY
Saline
Trumenba
MenACWY-CRM
Countries
United States
Czechia
Denmark
Hungary
Poland
Protocol Section
Identification Module
NCT ID
NCT04440163
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C3511001
Secondary IDs
ID
Type
Description
Link
2019-004313-13
EudraCT Number
Brief Title
MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
Official Title
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 17, 2020Actual
Primary Completion Date
Jul 24, 2022Actual
Completion Date
Jul 24, 2022Actual
First Submitted Date
Jun 15, 2020
First Submission Date that Met QC Criteria
Jun 18, 2020
First Posted Date
Jun 19, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 22, 2023
Results First Submitted that Met QC Criteria
Mar 22, 2023
Results First Posted Date
Apr 18, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 22, 2023
Last Update Posted Date
Apr 18, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to <26 years of age.
Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subject aged >=10 and <26 years at the time of randomization.
Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
Negative urine pregnancy test for all female subjects.
ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.
Exclusion Criteria:
Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide (nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.- Subjects receiving any allergen immunotherapy with a non-licensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Current chronic use of systemic antibiotics.
Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 28 days prior to study entry and/or during study participation.
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
A total of 2431 participants were enrolled and randomized in the study of which 18 participants did not receive any vaccination. Out of 2431 participants, 2413 participants received at least 1 dose of vaccination.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), Neisseria meningitidis group A, C, W, and Y (ACWY) naive participants received a single dose of 0.5 milliliter (mL) Neisseria meningitidis serogroup A, B, C, W, Y (MenABCWY) intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
1 month after Vaccination 2
Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius (C) and was 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 deg C and was 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 2
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 1
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 7 days after Vaccination 2
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after Vaccination 1
Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after Vaccination 2
Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after any vaccination
Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after Vaccination 1
Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after Vaccination 2
Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Within 30 days after any vaccination
Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 days after Vaccination 1
Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 days after Vaccination 2
Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 days after any vaccination
Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 days after Vaccination 1
Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 days after Vaccination 2
Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 Days after any vaccination
Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 minutes after Vaccination 1
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Within 30 minutes after Vaccination 2
Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Central Research Associates, Inc.
Birmingham
Alabama
35205
United States
Fiel Family and Sports Medicine, PC/CCT Research
Tempe
Arizona
85283
United States
Velocity Clinical Research (Banning)
Banning
California
92220
United States
Madera Family Medical Group
Madera
California
93637
United States
Center for Clinical Trials, LLC
Paramount
California
90723
United States
Center for Clinical Trials
Paramount
California
90723
United States
Optumcare Colorado Springs, LLC
Colorado Springs
Colorado
80922
United States
ALL Medical Research, LLC
Cooper City
Florida
33024
United States
Alliance for MultiSpecialty Research, LLC - Miami
Coral Gables
Florida
33134
United States
Health Awareness, Inc.
Jupiter
Florida
33458
United States
Altus Research
Lake Worth
Florida
33461
United States
Acevedo Clinical Research Associates
Miami
Florida
33142
United States
Healthy Life Research, Inc.
Miami
Florida
33175
United States
Bio-Medical Research, LLC
Miami
Florida
33184
United States
Crystal Biomedical Research, LLC
Miami Lakes
Florida
33014
United States
San Marcus Research Clinic, Inc.
Miami Lakes
Florida
33014
United States
Complete Health Research
Ormond Beach
Florida
32174
United States
Oviedo Medical Research, LLC
Oviedo
Florida
32765
United States
PAS Research
Tampa
Florida
33613
United States
Tekton Research, Inc.
Chamblee
Georgia
30341
United States
Velocity Clinical Research - Boise
Meridian
Idaho
83642
United States
Saltzer Health
Nampa
Idaho
83686
United States
MOC Research
Mishawaka
Indiana
46544
United States
The South Bend Clinic Center for Research
South Bend
Indiana
46617
United States
The Iowa Clinic
Ankeny
Iowa
50023
United States
The Iowa Clinic
West Des Moines
Iowa
50266
United States
Alliance for Multispecialty Research, LLC
El Dorado
Kansas
67042
United States
Alliance for Multispecialty Research, LLC
Newton
Kansas
67114
United States
Michael W. Simon, MD, PSC
Lexington
Kentucky
40517
United States
Meridian Clinical Research, LLC
Baton Rouge
Louisiana
70806
United States
Meridian Clinical Research, LLC
Baton Rouge
Louisiana
70809
United States
Acorn to Oak Pediatrics - ACC Pediatric Research
Haughton
Louisiana
71037
United States
Sundance Clinical Research, LLC
St Louis
Missouri
63141
United States
Skyline Medical Center, PC/CCT Research
Elkhorn
Nebraska
68022
United States
Quality Clinical Research
Omaha
Nebraska
68114
United States
Meridian Clinical Research, LLC
Binghamton
New York
13901
United States
PMG Research of Salisbury, LLC
Salisbury
North Carolina
28144
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28401
United States
Accellacare - Winston-Salem
Winston-Salem
North Carolina
27103
United States
PMG Research of Winston-Salem, LLC
Winston-Salem
North Carolina
27103
United States
Velocity Clinical Research - Cleveland
Cleveland
Ohio
44122
United States
Dayton Clinical Research
Dayton
Ohio
45409
United States
Pediatric Associates of Fairfield, Inc.
Fairfield
Ohio
45014
United States
Senders Pediatrics
South Euclid
Ohio
44121
United States
Lynn Institute of Norman
Norman
Oklahoma
73072
United States
Tekton Research
Yukon
Oklahoma
73099
United States
Liberty Family Practice
Erie
Pennsylvania
16508
United States
Thomas Jefferson University
Philadelphia
Pennsylvania
19107
United States
Accellacare US Inc.
Mt. Pleasant
South Carolina
29464
United States
Internal Medicine and Pediatric Associates of Bristol, PC
Bristol
Tennessee
37620
United States
Holston Medical Group
Kingsport
Tennessee
37660
United States
Family Medicine Associates of Texas
Carrollton
Texas
75010
United States
AIM Trials, LLC
Plano
Texas
75093
United States
North Texas Family Medicine
Plano
Texas
75093
United States
Tekton Research
San Antonio
Texas
78229
United States
Olympus Family Medicine/CCT Research
Holladay
Utah
84117
United States
Pediatric Care
Provo
Utah
84604
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City
Utah
84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City
Utah
84121
United States
J. Lewis Research, Inc. / Jordan River Family Medicine
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of meningococcal (groups A, C, Y, and W-135) oligosaccharide diphtheria conjugate vaccine (MenACWY-CRM) intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3,participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG002
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG003
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG004
ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2). and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG005
ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG006
ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG007
ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
FG000552 subjects
FG001276 subjects
FG002528 subjects
FG003261 subjectsOne participant initially randomized to group 3 was included in group 4 as participant received the wrong vaccination (Trumenba + saline).
FG004544 subjects
FG00557 subjects
FG006154 subjects
FG00759 subjects
Vaccination 1
FG000547 subjects
FG001274 subjects
FG002526 subjects
FG003261 subjects
FG004537 subjects
FG00556 subjects
FG006153 subjects
FG00759 subjects
Vaccination 2
FG000500 subjects
FG001254 subjects
FG002453 subjects
FG003218 subjects
FG004481 subjects
FG00546 subjects
FG006123 subjects
FG00745 subjects
COMPLETED
FG000490 subjects
FG001248 subjects
FG002440 subjects
FG003209 subjects
FG004476 subjects
FG00545 subjects
FG006122 subjects
FG00744 subjects
NOT COMPLETED
FG00062 subjects
FG00128 subjects
FG00288 subjects
FG00352 subjects
FG00468 subjects
FG00512 subjects
FG00632 subjects
FG00715 subjects
Type
Comment
Reasons
Lost to Follow-up
FG00026 subjects
FG00115 subjects
FG00242 subjects
FG00322 subjects
FG00430 subjects
FG0053 subjects
FG00618 subjects
FG0075 subjects
Medication error without associated adverse event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
No longer met eligibility criteria
FG0005 subjects
FG0011 subjects
FG0025 subjects
FG0032 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0025 subjects
FG0033 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG004
Adverse Event
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG00011 subjects
FG0015 subjects
FG00218 subjects
FG00314 subjects
FG004
Withdrawal by parent/guardian
FG00010 subjects
FG0014 subjects
FG00211 subjects
FG0037 subjects
FG004
Withdrawn before vaccination
FG0005 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Follow-up Phase (Approx. 5 Months)
Type
Comment
Milestone Data
STARTED
FG000490 subjects
FG001248 subjects
FG002440 subjects
FG003209 subjects
FG004476 subjects
FG00545 subjects
FG006122 subjects
FG00744 subjects
COMPLETED
FG000487 subjects
FG001243 subjects
FG002440 subjects
FG003208 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG003
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. One participant initially randomized to group 3 was excluded from safety population set as the participant received the wrong vaccination (Trumenba + saline).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG001
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG002
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG003
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG004
ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG005
ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG006
ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG007
ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000547
BG001274
BG002526
BG003260
BG004537
BG00556
BG006153
BG00759
BG0082412
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00016.7± 5.49
BG00116.7± 5.39
BG00217.3± 3.17
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000289
BG001140
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00093
BG00153
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving At Least 4-Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) Titer From Baseline for Each MenACWY Strains: 1 Month After Vaccination 2 in Group 1 Compared to 1 Month After Vaccination 1 in Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below limit of detection (LOD) (or hSBA titer less than [<] 1:4), 4-fold rise was defined as hSBA titer greater than or equal to (>=) 1:16; 2) baseline hSBA titer >=LOD and < lower limit of quantitation (LLOQ) (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided confidence interval (CI) using Clopper and Pearson method was presented. Analysis was performed on post-vaccination (PV) 1 evaluable immunogenicity population (EIP) for Group 2 and PV2 evaluable immunogenicity population for Group 1. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
PV1 EIP and PV2 EIP: randomized to study group of interest; eligible at visit (V) 2 and 4 respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result; no prohibited vaccine/treatment, no protocol deviations through V2 and V4, respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
ID
Title
Description
OG000
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000451
OG001254
Title
Denominators
Categories
MenA
ParticipantsOG000447
ParticipantsOG001254
Title
Measurements
OG00097.8(95.9 to 98.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MenA
Based on Miettinen and Nurminen method.
Difference in percentage of participants
2.5
2-Sided
95
-0.2
6.0
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was greater than (>) minus (-)10 percent (%), the non-inferiority was concluded.
Primary
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each of the MenACWY Strains: 1 Month After Vaccination 2 in Group 3 Compared to 1 Month After Vaccination 1 in Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e., hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented. Here, 'Overall Number of Participants Analyzed' represented as 'N' and 'Number Analyzed' represented as 'n'.
PV1 and PV2 EIP for Group 4 and Group 3, respectively: randomized to study group of interest; eligible at V2 and V4, respectively; received vaccine at V1 or V1 and V3, respectively; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenACWY/MenB assay result, no prohibited vaccines/treatment, no protocol deviations through V2 and V4 respectively. N=participants evaluable for outcome measure; n=participants evaluable for rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
ID
Title
Description
OG000
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants Achieving hSBA Titer Greater Than or Equal to (>=) LLOQ for All Primary Neisseria Meningitidis Group B (MenB) Test Strains Combined (Composite Response): Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Percentage of participants achieving hSBA titer >= LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for all MenB test strains (A22, A56, B24 and B44) combined were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; had at least 1 valid, determinate MenACWY or MenB assay result at V4; received no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
1 month after Vaccination 2
ID
Title
Description
OG000
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants Achieving At Least a 4-Fold Rise in hSBA Titer From Baseline For Each Primary MenB Test Strains at 1 Month After Vaccination 2: Groups 1 and 3 Combined Versus Groups 2 and 4 Combined
Percentage of participants achieving at least a 4-fold rise in hSBA titer for each primary MenB test strains (A22, A56, B24 and B44) were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
PV2 EIP: participants randomized to study group of interest; eligible at V4; received vaccine at V1 and V3; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY or MenB assay result at V4; no prohibited vaccines; no protocol deviations through V4. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for outcome measure and 'Number Analyzed' signifies number of participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
ID
Title
Description
OG000
Groups 1+3 Combined MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" (N) signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 7 days after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in caliper units. 1 caliper unit =0.5 cm and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm and severe: >10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. Percentage of participants with local reactions at injection site were reported in this outcome measure. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 degrees (deg) Celsius (C) and was 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Systemic events were recorded by participants in e-diary. Fever was defined as temperature >=38.0 deg C and was 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. Fatigue, headache, chills, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication was recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
The use of antipyretic medication recorded by participants in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With AEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With AEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after any vaccination
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With SAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With SAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after any vaccination
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With SAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With MAEs Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With MAEs Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after any vaccination
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With MAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With MAEs During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With MAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 days after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With NDCMC Within 30 Days After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With NDCMC Within 30 Days After Any Vaccination: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 Days after any vaccination
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With NDCMC During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With NDCMC During Follow-up Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Number
95% Confidence Interval
Percentage of participants
From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Primary
Percentage of Participants With NDCMC Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
An NDCMC was defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
95% Confidence Interval
Percentage of participants
Within 30 minutes after Vaccination 1
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
Primary
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
Immediate AEs were defined as AEs occurring within the first 30 minutes after investigational product administration. Exact 2-sided CI was based on the Clopper and Pearson method.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination. 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
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
OG001
Primary
Percentage of Participants Who Missed Days of School or Work Due to AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined)
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. Percentage of participants who missed days of school or work due to AEs during vaccination phase were reported in this outcome measure.
Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
Posted
Number
Percentage of participants
From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
ID
Title
Description
OG000
Groups 1+3+5+7 Combined MenABCWY + Saline
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Secondary
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 1 Compared to Group 2
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4times LLOQ; 3) baseline hSBA titer >=LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
PV1 EIP: participants randomized to study group of interest; eligible at V2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines; no protocol deviations through V2. Here "Overall Number of Participants Analyzed" = participants evaluable for outcome measure and "Number Analyzed" = number of participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
ID
Title
Description
OG000
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Secondary
Percentage of Participants Achieving At Least 4-Fold Rise in hSBA Titer From Baseline for Each MenACWY Test Strains: 1 Month After Vaccination 1 in Group 3 Compared to Group 4
4-fold increase was defined as: 1) for participants with baseline hSBA titer below LOD (or hSBA titer <1:4), 4-fold rise was defined as hSBA titer >=1:16; 2) baseline hSBA titer >=LOD (i.e., hSBA titer of >=1:4) and < LLOQ (i.e. hSBA titer of 1:8), 4-fold rise was defined as hSBA titer >=4 times LLOQ; 3) baseline hSBA titer > =LLOQ, 4-fold rise was defined as hSBA titer >=4 times baseline titer. Exact 2-sided CI using Clopper and Pearson method was presented.
PV1 EIP: participants randomised to study group of interest; eligible at V 2; received vaccine at V1; blood drawn for assay testing at specified time points; at least 1 valid, determinate MenACWY assay result at V2; no prohibited vaccines and no protocol deviations through V2. Here "Overall Number of Participants Analyzed" = participants evaluable for outcome measure and "Number Analyzed" = number of participants evaluable for specified rows.
Posted
Number
95% Confidence Interval
Percentage of participants
Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
ID
Title
Description
OG000
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Time Frame
Local reactions and systemic events recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 6 months after vaccination 2 (approximately 12 months) and other AEs recorded using non-systematic assessment from Day 1 up to 1 month after vaccination 2 (approximately 7 months)
Description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
547
6
547
533
547
EG001
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
274
1
274
262
274
EG002
ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
526
3
526
504
526
EG003
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
260
2
260
244
260
EG004
ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
537
2
537
512
537
EG005
ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
56
1
56
53
56
EG006
ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL MenABCWY intramuscularly into the left deltoid muscle along with 0.5 mL of saline intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of MenABCWY intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
153
0
153
148
153
EG007
ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to safety analyses only. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
0
59
0
59
58
59
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Postural orthostatic tachycardia syndrome
Cardiac disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG0030 affected260 at risk
EG004
Appendicitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0011 affected274 at risk
EG0020 affected526 at risk
EG003
Escherichia urinary tract infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Spinal cord injury
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Food intolerance
Metabolism and nutrition disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Status migrainosus
Nervous system disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Disruptive mood dysregulation disorder
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerumen impaction
Ear and labyrinth disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0011 affected274 at risk
EG0024 affected526 at risk
EG0032 affected260 at risk
EG0042 affected537 at risk
EG0050 affected56 at risk
EG0061 affected153 at risk
EG0072 affected59 at risk
Ear pain
Ear and labyrinth disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0023 affected526 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0022 affected526 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0010 affected274 at risk
EG0025 affected526 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0022 affected526 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Diarrhoea (DIARRHEA)
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00069 affected547 at risk
EG00150 affected274 at risk
EG002116 affected526 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0010 affected274 at risk
EG0022 affected526 at risk
EG003
Vomiting (VOMITING)
Gastrointestinal disorders
MedDRA 25.0
Systematic Assessment
EG00023 affected547 at risk
EG00113 affected274 at risk
EG00222 affected526 at risk
EG003
Chills (CHILLS)
General disorders
MedDRA 25.0
Systematic Assessment
EG000155 affected547 at risk
EG00178 affected274 at risk
EG002151 affected526 at risk
EG003
Fatigue
General disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Fatigue (FATIGUE)
General disorders
MedDRA 25.0
Systematic Assessment
EG000364 affected547 at risk
EG001183 affected274 at risk
EG002337 affected526 at risk
EG003
Injection site pain (PAIN AT INJECTION SITE)
General disorders
MedDRA 25.0
Systematic Assessment
EG000522 affected547 at risk
EG001247 affected274 at risk
EG002486 affected526 at risk
EG003
Pyrexia
General disorders
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0010 affected274 at risk
EG0022 affected526 at risk
EG003
Pyrexia (FEVER)
General disorders
MedDRA 25.0
Systematic Assessment
EG00044 affected547 at risk
EG00124 affected274 at risk
EG00229 affected526 at risk
EG003
Swelling (SWELLING)
General disorders
MedDRA 25.0
Systematic Assessment
EG000186 affected547 at risk
EG00171 affected274 at risk
EG002158 affected526 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
COVID-19
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG00022 affected547 at risk
EG00112 affected274 at risk
EG00224 affected526 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0011 affected274 at risk
EG0021 affected526 at risk
EG003
Impetigo
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Influenza
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Lice infestation
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0011 affected274 at risk
EG0020 affected526 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0016 affected274 at risk
EG0021 affected526 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0012 affected274 at risk
EG0020 affected526 at risk
EG003
Otitis media
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0012 affected274 at risk
EG0024 affected526 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0005 affected547 at risk
EG0014 affected274 at risk
EG00210 affected526 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0012 affected274 at risk
EG0023 affected526 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0005 affected547 at risk
EG0014 affected274 at risk
EG0024 affected526 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG00010 affected547 at risk
EG0017 affected274 at risk
EG00217 affected526 at risk
EG003
Viral infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0012 affected274 at risk
EG0020 affected526 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0012 affected274 at risk
EG0021 affected526 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0011 affected274 at risk
EG0026 affected526 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0006 affected547 at risk
EG0012 affected274 at risk
EG0025 affected526 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0002 affected547 at risk
EG0012 affected274 at risk
EG0020 affected526 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0011 affected274 at risk
EG0020 affected526 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 25.0
Non-systematic Assessment
EG0006 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 25.0
Non-systematic Assessment
EG0004 affected547 at risk
EG0012 affected274 at risk
EG0028 affected526 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0012 affected274 at risk
EG0024 affected526 at risk
EG003
Arthralgia (JOINT PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG000156 affected547 at risk
EG00175 affected274 at risk
EG002156 affected526 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Myalgia (MUSCLE PAIN)
Musculoskeletal and connective tissue disorders
MedDRA 25.0
Systematic Assessment
EG000198 affected547 at risk
EG00197 affected274 at risk
EG002207 affected526 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0011 affected274 at risk
EG0021 affected526 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Headache (HEADACHE)
Nervous system disorders
MedDRA 25.0
Systematic Assessment
EG000330 affected547 at risk
EG001152 affected274 at risk
EG002312 affected526 at risk
EG003
Migraine
Nervous system disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0011 affected274 at risk
EG0021 affected526 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0021 affected526 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0011 affected274 at risk
EG0021 affected526 at risk
EG003
Heavy menstrual bleeding
Reproductive system and breast disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0010 affected274 at risk
EG0026 affected526 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0022 affected526 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 25.0
Non-systematic Assessment
EG0003 affected547 at risk
EG0012 affected274 at risk
EG0023 affected526 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0011 affected274 at risk
EG0025 affected526 at risk
EG003
Alopecia areata
Skin and subcutaneous tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0011 affected274 at risk
EG0020 affected526 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0001 affected547 at risk
EG0011 affected274 at risk
EG0020 affected526 at risk
EG003
Erythema (REDNESS)
Skin and subcutaneous tissue disorders
MedDRA 25.0
Systematic Assessment
EG000183 affected547 at risk
EG00175 affected274 at risk
EG002162 affected526 at risk
EG003
Keratosis pilaris
Skin and subcutaneous tissue disorders
MedDRA 25.0
Non-systematic Assessment
EG0000 affected547 at risk
EG0010 affected274 at risk
EG0020 affected526 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenW
Difference in percentage of participants
24.3
2-Sided
95
18.8
30.4
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenY
Difference in percentage of participants
23.8
2-Sided
95
18.0
30.1
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG001
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000387
OG001227
Title
Denominators
Categories
MenA
ParticipantsOG000385
ParticipantsOG001227
Title
Measurements
OG00093.8(90.9 to 96.0)
OG00196.9(93.7 to 98.8)
MenC
ParticipantsOG000386
ParticipantsOG001226
Title
Measurements
OG00093.8(90.9 to 96.0)
OG001
MenW
ParticipantsOG000386
ParticipantsOG001222
Title
Measurements
OG00097.1(94.8 to 98.5)
OG001
MenY
ParticipantsOG000387
ParticipantsOG001223
Title
Measurements
OG00093.0(90.0 to 95.4)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MenA
Difference in percentage of participants
-3.2
2-Sided
95
-6.5
0.5
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenC
Difference in percentage of participants
-0.9
2-Sided
95
-4.6
3.3
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenW
Difference in percentage of participants
0.7
2-Sided
95
-2.2
4.3
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenY
Difference in percentage of participants
-0.7
2-Sided
95
-4.6
3.8
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG001
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000755
OG001383
Title
Denominators
Categories
Title
Measurements
OG00078.3(75.2 to 81.2)
OG00168.7(63.8 to 73.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference in percentage of participants
9.6
2-Sided
95
4.2
15.2
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG001
Groups 2+4 Combined Trumenba + MenACWY-CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000845
OG001419
Title
Denominators
Categories
A22
ParticipantsOG000778
ParticipantsOG001396
Title
Measurements
OG00083.0(80.2 to 85.6)
OG00179.0(74.7 to 82.9)
A56
ParticipantsOG000807
ParticipantsOG001400
Title
Measurements
OG00095.9(94.3 to 97.2)
OG001
B24
ParticipantsOG000833
ParticipantsOG001418
Title
Measurements
OG00068.1(64.8 to 71.2)
OG001
B44
ParticipantsOG000845
ParticipantsOG001419
Title
Measurements
OG00086.5(84.0 to 88.7)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
A22
Difference in percentage of participants
4.0
2-Sided
95
-0.7
8.9
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
A56
Difference in percentage of participants
1.4
2-Sided
95
-1.0
4.3
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
B24
Difference in percentage of participants
10.9
2-Sided
95
5.2
16.6
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
B44
Difference in percentage
7.3
2-Sided
95
2.9
11.9
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001722
OG001630
Title
Denominators
Categories
Redness: Mild
Title
Measurements
OG0008.8(7.5 to 10.3)
OG0017.3(5.4 to 9.6)
Redness: Moderate
Title
Measurements
OG00014.5(12.8 to 16.2)
OG00110.0(7.8 to 12.6)
Redness: Severe
Title
Measurements
OG0002.5(1.8 to 3.3)
OG0012.2(1.2 to 3.7)
Swelling: Mild
Title
Measurements
OG00010.5(9.0 to 12.0)
OG0018.3(6.2 to 10.7)
Swelling: Moderate
Title
Measurements
OG00013.3(11.7 to 15.0)
OG00112.4(9.9 to 15.2)
Swelling: Severe
Title
Measurements
OG0001.2(0.7 to 1.8)
OG0010.8(0.3 to 1.8)
Pain at injection site: Mild
Title
Measurements
OG00032.3(30.1 to 34.6)
OG00131.1(27.5 to 34.9)
Pain at injection site: Moderate
Title
Measurements
OG00049.5(47.1 to 51.9)
OG00147.6(43.7 to 51.6)
Pain at injection site: Severe
Title
Measurements
OG0007.5(6.3 to 8.8)
OG0016.3(4.6 to 8.5)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001456
OG001529
Title
Denominators
Categories
Redness: Mild
Title
Measurements
OG0007.7(6.4 to 9.2)
OG0016.6(4.7 to 9.1)
Redness: Moderate
Title
Measurements
OG00012.6(10.9 to 14.4)
OG0017.2(5.1 to 9.7)
Redness: Severe
Title
Measurements
OG0003.0(2.1 to 4.0)
OG0010.9(0.3 to 2.2)
Swelling: Mild
Title
Measurements
OG00010.4(8.9 to 12.1)
OG0016.4(4.5 to 8.9)
Swelling: Moderate
Title
Measurements
OG00012.8(11.1 to 14.6)
OG0018.1(5.9 to 10.8)
Swelling: Severe
Title
Measurements
OG0001.0(0.5 to 1.6)
OG0010.2(0.0 to 1.0)
Pain at injection site: Mild
Title
Measurements
OG00029.1(26.7 to 31.5)
OG00133.1(29.1 to 37.3)
Pain at injection site: Moderate
Title
Measurements
OG00048.8(46.2 to 51.4)
OG00140.3(36.1 to 44.6)
Pain at injection site: Severe
Title
Measurements
OG0006.5(5.3 to 7.9)
OG0015.3(3.5 to 7.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001739
OG001638
Title
Denominators
Categories
Fever: 38.0 deg C to 38.4 deg C
Title
Measurements
OG0003.7(2.8 to 4.7)
OG0012.0(1.1 to 3.5)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0001.6(1.0 to 2.3)
OG0012.8(1.7 to 4.4)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000.6(0.3 to 1.1)
OG0010.9(0.3 to 2.0)
Fever: >40.0 deg C
Title
Measurements
OG0000.0(0.0 to 0.2)
OG0010.0(0.0 to 0.6)
Fatigue: Mild
Title
Measurements
OG00023.5(21.5 to 25.5)
OG00125.7(22.4 to 29.3)
Fatigue: Moderate
Title
Measurements
OG00025.5(23.4 to 27.6)
OG00125.7(22.4 to 29.3)
Fatigue: Severe
Title
Measurements
OG0003.2(2.4 to 4.1)
OG0013.3(2.0 to 5.0)
Headache: Mild
Title
Measurements
OG00025.6(23.6 to 27.8)
OG00124.5(21.2 to 28.0)
Headache: Moderate
Title
Measurements
OG00019.2(17.4 to 21.1)
OG00120.4(17.3 to 23.7)
Headache: Severe
Title
Measurements
OG0001.9(1.3 to 2.7)
OG0012.0(1.1 to 3.5)
Chills: Mild
Title
Measurements
OG00012.6(11.1 to 14.2)
OG00110.2(8.0 to 12.8)
Chills: Moderate
Title
Measurements
OG0006.7(5.5 to 7.9)
OG0017.8(5.9 to 10.2)
Chills: Severe
Title
Measurements
OG0000.8(0.4 to 1.3)
OG0011.6(0.8 to 2.9)
Vomiting: Mild
Title
Measurements
OG0002.5(1.8 to 3.4)
OG0012.0(1.1 to 3.5)
Vomiting: Moderate
Title
Measurements
OG0000.6(0.3 to 1.1)
OG0010.9(0.3 to 2.0)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 0.2)
OG0010.0(0.0 to 0.6)
Diarrhea: Mild
Title
Measurements
OG0008.7(7.5 to 10.2)
OG00111.9(9.5 to 14.7)
Diarrhea: Moderate
Title
Measurements
OG0002.0(1.4 to 2.7)
OG0011.6(0.8 to 2.9)
Diarrhea: Severe
Title
Measurements
OG0000.3(0.1 to 0.7)
OG0010.0(0.0 to 0.6)
Muscle Pain: Mild
Title
Measurements
OG00013.6(12.0 to 15.3)
OG00113.5(10.9 to 16.4)
Muscle Pain: Moderate
Title
Measurements
OG00010.5(9.1 to 12.1)
OG00111.9(9.5 to 14.7)
Muscle Pain: Severe
Title
Measurements
OG0001.6(1.1 to 2.3)
OG0012.0(1.1 to 3.5)
Joint Pain: Mild
Title
Measurements
OG00010.7(9.3 to 12.2)
OG00112.9(10.4 to 15.7)
Joint Pain: Moderate
Title
Measurements
OG0008.6(7.3 to 10.0)
OG0018.6(6.6 to 11.1)
Joint Pain: Severe
Title
Measurements
OG0001.0(0.6 to 1.6)
OG0011.1(0.4 to 2.2)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001459
OG001532
Title
Denominators
Categories
Fever: 38.0 deg C to 38.4 deg C
Title
Measurements
OG0001.8(1.2 to 2.6)
OG0010.4(0.0 to 1.4)
Fever: >38.4 deg C to 38.9 deg C
Title
Measurements
OG0000.3(0.1 to 0.7)
OG0010.9(0.3 to 2.2)
Fever: >38.9 deg C to 40.0 deg C
Title
Measurements
OG0000.2(0.0 to 0.6)
OG0010.2(0.0 to 1.0)
Fever: >40.0 deg C
Title
Measurements
OG0000.0(0.0 to 0.3)
OG0010.0(0.0 to 0.7)
Fatigue: Mild
Title
Measurements
OG00022.8(20.7 to 25.1)
OG00122.0(18.5 to 25.8)
Fatigue: Moderate
Title
Measurements
OG00021.8(19.7 to 24.0)
OG00119.9(16.6 to 23.6)
Fatigue: Severe
Title
Measurements
OG0002.9(2.1 to 3.9)
OG0011.7(0.8 to 3.2)
Headache: Mild
Title
Measurements
OG00021.3(19.2 to 23.5)
OG00121.1(17.7 to 24.8)
Headache: Moderate
Title
Measurements
OG00016.8(14.9 to 18.8)
OG00116.2(13.1 to 19.6)
Headache: Severe
Title
Measurements
OG0001.7(1.1 to 2.5)
OG0010.6(0.1 to 1.6)
Chills: Mild
Title
Measurements
OG0009.9(8.5 to 11.6)
OG0018.8(6.6 to 11.6)
Chills: Moderate
Title
Measurements
OG0006.0(4.9 to 7.4)
OG0015.8(4.0 to 8.2)
Chills: Severe
Title
Measurements
OG0000.4(0.2 to 0.9)
OG0011.5(0.7 to 2.9)
Vomiting: Mild
Title
Measurements
OG0001.4(0.8 to 2.1)
OG0010.8(0.2 to 1.9)
Vomiting: Moderate
Title
Measurements
OG0000.1(0.0 to 0.5)
OG0010.2(0.0 to 1.0)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 0.3)
OG0010.0(0.0 to 0.7)
Diarrhea: Mild
Title
Measurements
OG0006.9(5.6 to 8.3)
OG0016.0(4.2 to 8.4)
Diarrhea: Moderate
Title
Measurements
OG0001.4(0.8 to 2.1)
OG0012.4(1.3 to 4.1)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 0.3)
OG0010.0(0.0 to 0.7)
Muscle Pain: Mild
Title
Measurements
OG00010.0(8.5 to 11.7)
OG00110.0(7.6 to 12.8)
Muscle Pain: Moderate
Title
Measurements
OG00011.9(10.3 to 13.7)
OG00111.5(8.9 to 14.5)
Muscle Pain: Severe
Title
Measurements
OG0000.8(0.4 to 1.4)
OG0010.8(0.2 to 1.9)
Joint Pain: Mild
Title
Measurements
OG0009.6(8.1 to 11.2)
OG0017.9(5.7 to 10.5)
Joint Pain: Moderate
Title
Measurements
OG0008.3(6.9 to 9.8)
OG0016.8(4.8 to 9.2)
Joint Pain: Severe
Title
Measurements
OG0000.4(0.2 to 0.9)
OG0010.9(0.3 to 2.2)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001739
OG001638
Title
Denominators
Categories
Title
Measurements
OG00029.5(27.4 to 31.7)
OG00128.1(24.6 to 31.7)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001459
OG001532
Title
Denominators
Categories
Title
Measurements
OG00025.1(22.9 to 27.4)
OG00120.5(17.1 to 24.2)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0005.8(4.7 to 7.0)
OG0016.5(4.7 to 8.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001558
OG001562
Title
Denominators
Categories
Title
Measurements
OG0005.3(4.3 to 6.6)
OG0013.7(2.3 to 5.7)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0009.7(8.4 to 11.2)
OG0019.1(7.0 to 11.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG00020.9(19.0 to 22.8)
OG00120.3(17.3 to 23.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.06(0.0 to 0.3)
OG0010.0(0.0 to 0.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001558
OG001562
Title
Denominators
Categories
Title
Measurements
OG0000.1(0.0 to 0.5)
OG0010.0(0.0 to 0.7)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.2(0.0 to 0.5)
OG0010.0(0.0 to 0.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.4(0.2 to 0.8)
OG0010.0(0.0 to 0.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001390
OG001509
Title
Denominators
Categories
Title
Measurements
OG0000.3(0.1 to 0.7)
OG0010.8(0.2 to 2.0)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.6(0.3 to 1.1)
OG0010.6(0.2 to 1.6)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0003.6(2.8 to 4.5)
OG0014.3(2.9 to 6.2)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001558
OG001562
Title
Denominators
Categories
Title
Measurements
OG0003.6(2.7 to 4.6)
OG0012.8(1.6 to 4.6)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0006.3(5.2 to 7.5)
OG0016.3(4.6 to 8.5)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG00014.9(13.3 to 16.7)
OG00114.3(11.7 to 17.3)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001390
OG001509
Title
Denominators
Categories
Title
Measurements
OG0009.3(7.8 to 10.9)
OG0017.5(5.3 to 10.1)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG00019.3(17.5 to 21.2)
OG00118.3(15.4 to 21.5)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.2(0.1 to 0.6)
OG0010.0(0.0 to 0.6)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001558
OG001562
Title
Denominators
Categories
Title
Measurements
OG0000.06(0.0 to 0.4)
OG0010.0(0.0 to 0.7)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000.3(0.1 to 0.7)
OG0010.0(0.0 to 0.6)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0001.1(0.7 to 1.7)
OG0010.3(0.0 to 1.1)
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001390
OG001509
Title
Denominators
Categories
Title
Measurements
OG0000.4(0.1 to 0.8)
OG0010.0(0.0 to 0.7)
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0001.4(0.9 to 2.1)
OG0010.3(0.0 to 1.1)
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
OG0010(NA to NA)Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001558
OG001562
Title
Denominators
Categories
Title
Measurements
OG0000(NA to NA)Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
OG0010(NA to NA)Lower and upper limit of 95% CI could not be estimated, due to insufficient participants with event.
OG001
Groups 2+4+6+8 Combined Trumenba + MenACWY-CRM
On Day 1 (Visit 1), ACWY naive and ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG0001763
OG001649
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG0014.5
OG001
ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY naive participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000501
OG001254
Title
Denominators
Categories
MenA
ParticipantsOG000499
ParticipantsOG001254
Title
Measurements
OG00097.0(95.1 to 98.3)
OG00195.3(91.9 to 97.5)
MenC
ParticipantsOG000501
ParticipantsOG001252
Title
Measurements
OG00062.9(58.5 to 67.1)
OG001
MenW
ParticipantsOG000492
ParticipantsOG001244
Title
Measurements
OG00079.3(75.4 to 82.8)
OG001
MenY
ParticipantsOG000494
ParticipantsOG001248
Title
Measurements
OG00082.0(78.3 to 85.3)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MenA
Difference in percentage of participants
1.7
2-Sided
95
-1.0
5.3
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenC
Difference in percentage of participants
10.5
2-Sided
95
3.0
17.9
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenW
Difference in percentage of participants
6.3
2-Sided
95
-0.1
13.1
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenY
Difference in percentage of participants
11.4
2-Sided
95
5.0
18.2
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG001
ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set)
On Day 1 (Visit 1), ACWY experienced participants received a single dose of 0.5 mL Trumenba intramuscularly into the left deltoid muscle along with 0.5 mL of MenACWY-CRM intramuscularly into the right deltoid muscle (Vaccination 1). Participants were followed up for 1 month after Vaccination 1 (Visit 2). After 6 months of Vaccination 1 at Visit 3, participants received 0.5 mL of Trumenba intramuscularly into the left deltoid muscle (Vaccination 2) and were followed up for 1 month after Vaccination 2 (Visit 4). Vaccination phase was from Day 1 of Vaccination 1 through 1 month after Vaccination 2 (from Visit 1 to Visit 4). Participants were followed up for 6 months after last vaccination and contributed to both safety and immunogenicity analyses. . Follow-up phase was from 1 month after Vaccination 2 through 6 months after Vaccination 2.
Units
Counts
Participants
OG000442
OG001227
Title
Denominators
Categories
MenA
ParticipantsOG000439
ParticipantsOG001227
Title
Measurements
OG00094.8(92.2 to 96.7)
OG00196.9(93.7 to 98.8)
MenC
ParticipantsOG000439
ParticipantsOG001226
Title
Measurements
OG00093.4(90.7 to 95.5)
OG001
MenW
ParticipantsOG000428
ParticipantsOG001222
Title
Measurements
OG00097.4(95.4 to 98.7)
OG001
MenY
ParticipantsOG000442
ParticipantsOG001223
Title
Measurements
OG00094.3(91.8 to 96.3)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
MenA
Difference in percentage of participants
-2.2
2-Sided
95
-5.2
1.4
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenC
Difference in percentage of participants
-1.3
2-Sided
95
-4.9
2.9
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenW
Difference in percentage of participants
1.0
2-Sided
95
-1.6
4.6
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.
OG000
OG001
MenY
Difference in percentage of participants
0.6
2-Sided
95
-3.0
5.0
Non-Inferiority
95% CI for the difference in percentage of participants was calculated based on Miettinen and Nurminen. If the lower limit of the 2-sided 95% CI for the difference in percentage of participants was > -10%, the non-inferiority was concluded.