Clinical trial
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
Name
B1971060
Description
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.
Trial arms
Trial start
2021-08-18
Estimated PCD
2023-09-06
Trial end
2023-09-06
Status
Completed
Phase
Early phase I
Treatment
Trumenba
Bivalent recombinant lipoprotein 2086 vaccine
Arms:
Single Arm
Size
53
Primary endpoint
1. The 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.
1 month after Vaccination 2 in immunocompromised participants compared to historical age-matched healthy participants separately
2. Percentage of participants reporting local reactions within 7 days after each vaccination.
Within 7 days after each vaccination.
3. Percentage of participants reporting systemic events within 7 days after each vaccination.
Within 7 days after each vaccination.
4. Percentage of participants reporting use of antipyretic medication within 7 days after each vaccination.
Within 7 days after each vaccination.
5. Percentage of participants with at least 1 adverse event (AE) occurring 30 Days after each vaccination.
Within 30 Days after each vaccination
6. Percentage of participants with at least 1 AE occurring 30 Days after any vaccination.
Within 30 Days after any vaccination
7. Percentage of participants with at least 1 AE occurring during the vaccination phase.
During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2)
8. Percentage of participants with at least 1 immediate AE after each vaccination.
Throughout the study (from the time of vaccination administration until 30 minutes post vaccine administration)
9. Percentage of participants with at least 1 serious AE (SAE) within 30 Days after each vaccination.
Within 30 Days after each vaccination
10. Percentage of participants with at least 1 SAE within 30 Days after any vaccination.
Within 30 Days after any vaccination
11. Percentage of participants with at least 1 SAE during the vaccination phase.
During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2)
12. Percentage of participants with at least 1 SAE during the follow-up phase.
During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2)
13. Percentage of participants with at least 1 SAE throughout the study.
Throughout the study (from Vaccination 1 through 6 months after Vaccination 2)
14. Percentage of participants with at least 1 medically attended AE (MAE) within 30 Days after each vaccination.
Within 30 Days after each vaccination
15. Percentage of participants with at least 1 MAE within 30 Days after any vaccination.
Within 30 Days after any vaccination.
16. Percentage of participants with at least 1 MAE during the vaccination phase.
During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2)
17. Percentage of participants with at least 1 MAE during the follow-up phase.
During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2)
18. Percentage of participants with at least 1 MAE throughout the study.
Throughout the study (from Vaccination 1 through 6 months after Vaccination 2)
19. Percentage of participants with at least 1 newly diagnosed chronic medical condition (NDCMC) during the vaccination phase.
During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2)
20. Percentage of participants with at least 1 NDCMC during the follow-up phase.
During the follow-up phase (from 1 month after Vaccination 2 through 6 months after Vaccination 2)
21. Percentage of participants with at least 1 NDCMC throughout the study.
Throughout the study (from Vaccination 1 through 6 months after Vaccination 2)
22. Number of days participants missed school or work because of AEs during the vaccination phase
During the vaccination phase (from Vaccination 1 through 1 month after Vaccination 2)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 53, 'type': 'ACTUAL'}}
Updated at
2024-02-08
1 organization
1 product
1 indication
Organization
PfizerProduct
TrumenbaIndication
Meningococcal Vaccine