Meningococcal Vaccine
Conditions
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.
Interventions
BIOLOGICALMenACWY-CRM
Meningococcal group A, C, W-135, and Y conjugate vaccine
BIOLOGICALMenABCWY
N meningitidis groups A, B, C, W, and Y vaccine
BIOLOGICALSaline
Placebo
BIOLOGICALTrumenba
Bivalent recombinant lipoprotein 2086 vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) | 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. |
| 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) | Within 30 minutes after Vaccination 2 | 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. |
| 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) | Within 30 minutes after Vaccination 1 | 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. |
| 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 | Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 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'. |
| 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 | Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 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'. |
| 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 | 1 month 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. |
| 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 | Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 | 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. |
| 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) | Within 7 days after Vaccination 1 | 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. |
| 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) | Within 7 days after Vaccination 2 | 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. |
| 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) | Within 7 days after Vaccination 1 | 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. |
| 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) | Within 7 days after Vaccination 2 | 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. |
| 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) | Within 7 days after Vaccination 1 | 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. |
| 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) | Within 7 days after Vaccination 2 | 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. |
| 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) | Within 30 days after Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With 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) | Within 30 days after Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With 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) | Within 30 days after any vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With AEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) | From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. |
| Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 1: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) | Within 30 days after Vaccination 1 | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| 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) | Within 30 days after Vaccination 2 | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With 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) | Within 30 days after any vaccination | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With SAEs During Vaccination Phase: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) | From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With 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) | From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With SAEs Throughout the Study: By MenABCWY Group (Groups 1, 3, 5, and 7 Combined) and Trumenba Group (Groups 2, 4, 6, and 8 Combined) | From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) | An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/ incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method. |
| Percentage of Participants With 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) | Within 30 days after Vaccination 1 | 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. |
| 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) | Within 30 days after Vaccination 2 | 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. |
| 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) | Within 30 days after any vaccination | 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. |
| 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) | From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) | 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. |
| 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) | From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) | 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. |
| 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) | From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) | 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. |
| 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) | Within 30 days after Vaccination 1 | 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. |
| 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) | Within 30 days after Vaccination 2 | 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. |
| 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) | Within 30 Days after any vaccination | 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. |
| 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) | From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months) | 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. |
| 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) | From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months) | 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. |
| 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) | From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1 | 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. |
| 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 | Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1 | 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. |
Countries
Czechia, Denmark, Hungary, Poland, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 547 |
| 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. | 274 |
| 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. | 526 |
| 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. | 260 |
| 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. | 537 |
| 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. | 56 |
| 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. | 153 |
| 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. | 59 |
| Total | 2,412 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Follow-up Phase (Approx. 5 Months) | Lost to Follow-up | 3 | 5 | 0 | 0 | 1 | 0 | 2 | 1 |
| Follow-up Phase (Approx. 5 Months) | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Vaccination Phase (Approx. 7 Months) | Adverse Event | 3 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Vaccination Phase (Approx. 7 Months) | Lost to Follow-up | 26 | 15 | 42 | 22 | 30 | 3 | 18 | 5 |
| Vaccination Phase (Approx. 7 Months) | Medication error without associated adverse event | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Vaccination Phase (Approx. 7 Months) | No longer met eligibility criteria | 5 | 1 | 5 | 2 | 3 | 0 | 2 | 3 |
| Vaccination Phase (Approx. 7 Months) | Other | 0 | 0 | 3 | 2 | 0 | 1 | 0 | 1 |
| Vaccination Phase (Approx. 7 Months) | Pregnancy | 1 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
| Vaccination Phase (Approx. 7 Months) | Protocol Violation | 1 | 0 | 5 | 3 | 0 | 0 | 3 | 0 |
| Vaccination Phase (Approx. 7 Months) | Withdrawal by parent/guardian | 10 | 4 | 11 | 7 | 16 | 4 | 3 | 2 |
| Vaccination Phase (Approx. 7 Months) | Withdrawal by Subject | 11 | 5 | 18 | 14 | 10 | 3 | 5 | 4 |
| Vaccination Phase (Approx. 7 Months) | Withdrawn before vaccination | 5 | 2 | 2 | 0 | 7 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | ACWY-Experienced: Group 3 MenABCWY + Saline (Immunogenicity and Safety Set) | ACWY-Experienced: Group 4 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | ACWY-Naive: Group 5 MenABCWY + Saline (Safety Set) | ACWY-Naive: Group 6 Trumenba+ MenACWY - CRM (Safety Set) | ACWY-Experienced: Group 7 MenABCWY + Saline (Safety Set) | ACWY-Experienced: Group 8 Trumenba+ MenACWY - CRM (Safety Set) | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 16.7 Years STANDARD_DEVIATION 5.49 | 16.7 Years STANDARD_DEVIATION 5.39 | 17.3 Years STANDARD_DEVIATION 3.17 | 17.4 Years STANDARD_DEVIATION 3.28 | 13.5 Years STANDARD_DEVIATION 4.05 | 13.5 Years STANDARD_DEVIATION 4.5 | 17.1 Years STANDARD_DEVIATION 3.04 | 16.0 Years STANDARD_DEVIATION 2.75 | 16.1 Years STANDARD_DEVIATION 4.55 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 93 Participants | 53 Participants | 156 Participants | 86 Participants | 131 Participants | 15 Participants | 58 Participants | 29 Participants | 621 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 450 Participants | 217 Participants | 366 Participants | 173 Participants | 405 Participants | 41 Participants | 93 Participants | 30 Participants | 1775 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 16 Participants |
| Race (NIH/OMB) Asian | 19 Participants | 4 Participants | 18 Participants | 6 Participants | 7 Participants | 1 Participants | 1 Participants | 1 Participants | 57 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 19 Participants | 74 Participants | 32 Participants | 57 Participants | 5 Participants | 27 Participants | 5 Participants | 245 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 3 Participants | 12 Participants | 3 Participants | 7 Participants | 2 Participants | 2 Participants | 0 Participants | 38 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants | 7 Participants | 48 Participants | 22 Participants | 42 Participants | 1 Participants | 18 Participants | 10 Participants | 171 Participants |
| Race (NIH/OMB) White | 467 Participants | 239 Participants | 370 Participants | 195 Participants | 419 Participants | 46 Participants | 103 Participants | 42 Participants | 1881 Participants |
| Sex: Female, Male Female | 289 Participants | 140 Participants | 279 Participants | 131 Participants | 253 Participants | 20 Participants | 96 Participants | 28 Participants | 1236 Participants |
| Sex: Female, Male Male | 258 Participants | 134 Participants | 247 Participants | 129 Participants | 284 Participants | 36 Participants | 57 Participants | 31 Participants | 1176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 547 | 0 / 274 | 0 / 526 | 0 / 260 | 0 / 537 | 0 / 56 | 0 / 153 | 0 / 59 |
| other Total, other adverse events | 533 / 547 | 262 / 274 | 504 / 526 | 244 / 260 | 512 / 537 | 53 / 56 | 148 / 153 | 58 / 59 |
| serious Total, serious adverse events | 6 / 547 | 1 / 274 | 3 / 526 | 2 / 260 | 2 / 537 | 1 / 56 | 0 / 153 | 0 / 59 |
Outcome results
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'.
Time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 3 and 1 month after Vaccination 1 in Group 4
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenC | 93.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenW | 97.1 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenY | 93.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenA | 93.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenA | 96.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenC | 94.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenY | 93.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenW | 96.4 Percentage of participants |
Comparison: MenA95% CI: [-6.5, 0.5]
Comparison: MenC95% CI: [-4.6, 3.3]
Comparison: MenW95% CI: [-2.2, 4.3]
Comparison: MenY95% CI: [-4.6, 3.8]
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'.
Time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2 in Group 1 and 1 month after Vaccination 1 in Group 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenA | 97.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenC | 93.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenW | 97.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenY | 94.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenY | 70.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenA | 95.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenW | 73.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenC | 52.4 Percentage of participants |
Comparison: MenA95% CI: [-0.2, 6]Based on Miettinen and Nurminen method.
Comparison: MenC95% CI: [34.4, 47.5]
Comparison: MenW95% CI: [18.8, 30.4]
Comparison: MenY95% CI: [18, 30.1]
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.
Time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | A22 | 83.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | B24 | 68.1 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | B44 | 86.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | A56 | 95.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | B44 | 79.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | A22 | 79.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | A56 | 94.5 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | B24 | 57.2 Percentage of participants |
Comparison: A2295% CI: [-0.7, 8.9]
Comparison: A5695% CI: [-1, 4.3]
Comparison: B2495% CI: [5.2, 16.6]
Comparison: B4495% CI: [2.9, 11.9]
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.
Time frame: 1 month after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | 78.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | 68.7 Percentage of participants |
95% CI: [4.2, 15.2]
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.
Time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 5.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 4.5 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 5.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 6.5 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 20.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 20.3 Percentage of participants |
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.
Time frame: Within 30 days after any vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 9.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 9.1 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 5.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 3.7 Percentage of participants |
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.
Time frame: Within 30 minutes after Vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0 Percentage of participants |
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.
Time frame: Within 30 minutes after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Mild | 8.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Moderate | 49.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Moderate | 14.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Moderate | 13.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Severe | 2.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Severe | 7.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Mild | 10.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Severe | 1.2 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Mild | 32.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Mild | 31.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Moderate | 12.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Severe | 0.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Moderate | 47.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Severe | 6.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Mild | 7.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Moderate | 10.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Severe | 2.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Mild | 8.3 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Mild | 7.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Severe | 3.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Mild | 10.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Moderate | 12.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Swelling: Severe | 1.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Mild | 29.1 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Moderate | 48.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Pain at injection site: Severe | 6.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Redness: Moderate | 12.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Mild | 33.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Mild | 6.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Moderate | 7.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Redness: Severe | 0.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Moderate | 40.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Mild | 6.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Moderate | 8.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Pain at injection site: Severe | 5.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Swelling: Severe | 0.2 Percentage of participants |
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.
Time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 9.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 7.5 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 14.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 14.3 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 19.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 18.3 Percentage of participants |
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.
Time frame: Within 30 days after any vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 6.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 6.3 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 3.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 2.8 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 3.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 4.3 Percentage of participants |
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.
Time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 1.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.3 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 1.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.3 Percentage of participants |
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.
Time frame: Within 30 Days after any vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.06 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: From 1 month after Vaccination 2 up to 6 months after Vaccination 2 (approximately 5 months)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.8 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 1 month after Vaccination 2 (approximately 7 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: From day of Vaccination 1 (Day 1) up to 6 months after Vaccination 2 (approximately 12 months)
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.6 Percentage of participants |
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.
Time frame: Within 30 days after any vaccination
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: Within 30 days after Vaccination 1
Population: Safety population included all randomized participants who received at least 1 dose of investigational product and had safety data reported after vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 0.06 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 0.0 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >38.9 deg C to 40.0 deg C | 0.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >40.0 deg C | 0.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Mild | 23.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Moderate | 25.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Moderate | 19.2 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Severe | 1.9 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Mild | 12.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Moderate | 6.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Severe | 0.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Moderate | 0.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Mild | 8.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Moderate | 2.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Severe | 0.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Mild | 13.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Moderate | 10.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Severe | 1.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Severe | 1.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: 38.0 deg C to 38.4 deg C | 3.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >38.4 deg C to 38.9 deg C | 1.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Severe | 3.2 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Mild | 25.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Mild | 2.5 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Mild | 10.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Moderate | 8.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Moderate | 7.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Moderate | 11.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Severe | 3.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Mild | 25.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Severe | 2.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Mild | 24.5 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Mild | 12.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Moderate | 8.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Severe | 2.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Mild | 11.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Severe | 1.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Moderate | 20.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Severe | 1.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Mild | 2.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: 38.0 deg C to 38.4 deg C | 2.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Moderate | 0.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Mild | 10.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >38.4 deg C to 38.9 deg C | 2.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >38.9 deg C to 40.0 deg C | 0.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Moderate | 1.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >40.0 deg C | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Moderate | 25.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Mild | 13.5 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 2
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Mild | 21.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Moderate | 1.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >40.0 deg C | 0.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Moderate | 21.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Mild | 10.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: 38.0 deg C to 38.4 deg C | 1.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Moderate | 11.9 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Muscle Pain: Severe | 0.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Mild | 9.9 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Mild | 9.6 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Moderate | 6.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Moderate | 8.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Chills: Severe | 0.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Joint Pain: Severe | 0.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >38.9 deg C to 40.0 deg C | 0.2 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fever: >38.4 deg C to 38.9 deg C | 0.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Moderate | 16.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Headache: Severe | 1.7 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Mild | 1.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Moderate | 0.1 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Severe | 2.9 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Vomiting: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Fatigue: Mild | 22.8 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | Diarrhea: Mild | 6.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Mild | 10.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: 38.0 deg C to 38.4 deg C | 0.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >38.4 deg C to 38.9 deg C | 0.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >38.9 deg C to 40.0 deg C | 0.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fever: >40.0 deg C | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Mild | 22.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Moderate | 19.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Fatigue: Severe | 1.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Moderate | 16.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Severe | 0.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Severe | 1.5 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Moderate | 0.2 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Mild | 6.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Moderate | 2.4 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Diarrhea: Severe | 0.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Severe | 0.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Mild | 7.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Moderate | 6.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Headache: Mild | 21.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Mild | 8.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Chills: Moderate | 5.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Vomiting: Mild | 0.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Muscle Pain: Moderate | 11.5 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | Joint Pain: Severe | 0.9 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 1
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 29.5 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 28.1 Percentage of participants |
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.
Time frame: Within 7 days after Vaccination 2
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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) | 25.1 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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) | 20.5 Percentage of participants |
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.
Time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenA | 97.0 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenC | 62.9 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenW | 79.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenY | 82.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenY | 70.6 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenA | 95.3 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenW | 73.0 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenC | 52.4 Percentage of participants |
Comparison: MenA95% CI: [-1, 5.3]
Comparison: MenC95% CI: [3, 17.9]
Comparison: MenW95% CI: [-0.1, 13.1]
Comparison: MenY95% CI: [5, 18.2]
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.
Time frame: Baseline (pre-vaccination on Day 1), 1 month after Vaccination 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenC | 93.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenW | 97.4 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenY | 94.3 Percentage of participants |
| ACWY-Naive: Group 1 MenABCWY + Saline (Immunogenicity and Safety Set) | 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 | MenA | 94.8 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenA | 96.9 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenC | 94.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenY | 93.7 Percentage of participants |
| ACWY-Naive: Group 2 Trumenba+ MenACWY - CRM (Immunogenicity and Safety Set) | 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 | MenW | 96.4 Percentage of participants |
Comparison: MenA95% CI: [-5.2, 1.4]
Comparison: MenC95% CI: [-4.9, 2.9]
Comparison: MenW95% CI: [-1.6, 4.6]
Comparison: MenY95% CI: [-3, 5]