Phase 4
N=104
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
Meningococcal Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT04893811 ↗Enrolled (actual)
104
Serious AEs
10.6%
Results posted
Oct 2024
Primary outcome: 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 (MnB) Test Strains at Baseline — 32.6; 31.0; 25.6; 23.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Trumenba (Biological)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2023
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 (MnB) Test Strains at Baseline |
32.6; 31.0; 25.6; 23.3; 2.4; 23.3 | — |
| PRIMARY Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 |
75.0; 95.3; 90.9; 100.0; 70.5; 81.8 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 |
18.9; 11.8; 5.7; 5.9; 9.4; 3.9 | — |
| PRIMARY Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 |
20.0; 7.0; 6.7; 2.3; 11.1; 4.7 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 |
3.8; 2.0; 1.9; 0; 0; 2.0 | — |
| PRIMARY Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 |
2.2; 2.3; 2.2; 0; 0; 2.3 | — |
| PRIMARY Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1 |
34.0; 9.8 | — |
| PRIMARY Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2 |
28.9; 7.0 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1 |
26.4; 9.8 | — |
| PRIMARY Percentage of Participants Reporting AEs During 30 Days After Vaccination 2 |
12.8; 12.8 | — |
| PRIMARY Percentage of Participants Reporting AEs During 30 Days After Any Vaccination |
34.0; 17.6 | — |
| PRIMARY Percentage of Participants Reporting AEs During the Vaccination Phase |
60.4; 41.2 | — |
| PRIMARY Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1 |
9.4; 0 | — |
| PRIMARY Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2 |
0; 0 | — |
| PRIMARY Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination |
9.4; 0 | — |
| PRIMARY Percentage of Participants Reporting SAEs During the Vaccination Phase |
17.0; 0 | — |
| PRIMARY Percentage of Participants Reporting SAEs During the Follow-up Phase |
4.5; 2.1 | — |
| PRIMARY Percentage of Participants Reporting SAEs During the Entire Study |
18.9; 2.0 | — |
| PRIMARY Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1 |
20.8; 5.9 | — |
| PRIMARY Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2 |
12.8; 4.3 | — |
| PRIMARY Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination |
30.2; 9.8 | — |
| PRIMARY Percentage of Participants Reporting MAEs During the Vaccination Phase |
54.7; 29.4 | — |
| PRIMARY Percentage of Participants Reporting MAEs During the Follow-up Phase |
15.9; 10.4 | — |
| PRIMARY Percentage of Participants Reporting MAEs During the Entire Study |
60.4; 31.4 | — |
| PRIMARY Percentage of Participants Reporting Immediate AEs After Vaccination 1 |
0; 2.0 | — |
| PRIMARY Percentage of Participants Reporting Immediate AEs After Vaccination 2 |
0; 0 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase |
1.9; 0 | — |
| PRIMARY Percentage of Participants With NDCMC During the Follow-up Phase |
0; 0 | — |
| PRIMARY Percentage of Participants With NDCMC During the Entire Study |
1.9; 0 | — |
| PRIMARY Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase |
12.7; 2.5 | — |
Summary
The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥10 years of age at the time of consent.
- Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
- Negative urine pregnancy test for all female participants.
Exclusion Criteria
- Previous vaccination with any meningococcal serogroup B vaccine.
- Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- Any confirmed or suspected human immunodeficiency virus infection.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
- Current chronic use of systemic antibiotics.
- Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
- Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.
Data sourced from ClinicalTrials.gov (NCT04893811). 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.