Phase 2
Completed N=309
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Meningococcal Vaccine
Source: ClinicalTrials.gov NCT04440176 ↗
Enrolled (actual)
309
Serious AEs
1.4%
Results posted
Jan 2025
Primary outcomePrimary: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule — 7.0; 2.6; 1.7; 0.9 Percentage of participants
Summary
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule |
7.0; 2.6; 1.7; 0.9 | — |
| PRIMARY Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule |
99.1; 100.0; 98.2; 96.6 | — |
| PRIMARY Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule |
10.0; 1.1; 2.0; 1.0 | — |
| PRIMARY Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule |
100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule |
28.8 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule |
15.7 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule |
27.7 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule |
13.8 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule |
19.4 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule |
0.0; 6.2; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule |
0.0; 5.0; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule |
0.0; 7.4; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule |
0.0; 6.9; 0.8 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule |
0.0; 1.9; 0.0 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule |
34.9 | — |
| PRIMARY Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule |
32.4 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule |
0.0; 10.3; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule |
0.0; 8.8; 0.0 | — |
| PRIMARY Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule |
30.8 | — |
| PRIMARY Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule |
29.1 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule |
0.0; 8.2; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule |
0.0; 8.8; 0.0 | — |
| PRIMARY Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule |
15.7 | — |
| PRIMARY Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule |
16.2 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule |
0.0; 5.0; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule |
0.0; 6.9; 1.5 | — |
| PRIMARY Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule |
19.4 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule |
0.0; 3.9; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule |
0.7; 16.6; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule |
0.0; 14.2; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule |
0.8; 8.5; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule |
1.6; 9.4; 3.1 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule |
0.7; 23.3; 1.4 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule |
0.0; 19.6; 0.7 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule |
0.8; 13.2; 0.0 | — |
| PRIMARY Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule |
1.5; 14.6; 4.6 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule |
0.7 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule |
0.0 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule |
0.7 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule |
1.5 | — |
| PRIMARY Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule |
2.9 | — |
| PRIMARY Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule |
8.2 | — |
| PRIMARY Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule |
8.1 | — |
| PRIMARY Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule |
8.3 | — |
| PRIMARY Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule |
6.2 | — |
| PRIMARY Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule |
1.9 | — |
| SECONDARY Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population |
10.7; 98.6; 10.1; 79.3; 15.9; 98.6 | — |
| SECONDARY Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population |
6.9; 99.1; 9.6; 99.1; 16.7; 100.0 | — |
| SECONDARY Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population |
7.1; 100.0; 10.4; 80.4; 15.4; 98.6 | — |
| SECONDARY Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population |
7.1; 100.0; 12.0; 100.0; 16.2; 100.0 | — |
| SECONDARY Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule |
79.8; 86.0; 43.0; 55.5; 73.5; 75.0 | — |
| SECONDARY Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule |
100.0; 93.5; 100.0; 99.0; 98.0; 88.9 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants 11 through <15 years of age at the time of randomization.
- Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
- Available for the entire study period and can be reached by telephone.
- Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
- Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Exclusion Criteria
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
- History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
- Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
Data sourced from ClinicalTrials.gov (NCT04440176). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.