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Completed

NCT Number: NCT04893811

Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

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.

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Key information

Conditions

Meningococcal Vaccine Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Hereditary Complement Deficiency Diseases Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3, Brno, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trumenba

Biological

Bivalent recombinant lipoprotein 2086 vaccine

Primary outcomes

  1. 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

    Time frame: Baseline (Before Vaccination 1 on Day 1/Month 0)

    Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) more than or equal to (=>)1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 are reported. Evaluable immunogenicity population (EIP) included all participants who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4.

  2. Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2

    Time frame: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)

    Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) =>1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 were reported.

  3. Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1

    Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

  4. Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2

    Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

    Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

  5. Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1

    Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree Celsius (C), 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hours [hrs]), moderate (>2 times in 24 hrs) and severe (required intravenous [IV] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).

  6. Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2

    Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

    Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree C, 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).

  7. Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1

    Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

  8. Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2

    Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

  9. Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1

    Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

  10. Percentage of Participants Reporting AEs During 30 Days After Vaccination 2

    Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

  11. Percentage of Participants Reporting AEs During 30 Days After Any Vaccination

    Time frame: 30 Days after any Vaccination

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

  12. Percentage of Participants Reporting AEs During the Vaccination Phase

    Time frame: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

  13. Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1

    Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

  14. Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2

    Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

  15. Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination

    Time frame: 30 Days after any Vaccination

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

  16. Percentage of Participants Reporting SAEs During the Vaccination Phase

    Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

  17. Percentage of Participants Reporting SAEs During the Follow-up Phase

    Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.

  18. Percentage of Participants Reporting SAEs During the Entire Study

    Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

  19. Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1

    Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  20. Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2

    Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  21. Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination

    Time frame: 30 Days after any Vaccination

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  22. Percentage of Participants Reporting MAEs During the Vaccination Phase

    Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  23. Percentage of Participants Reporting MAEs During the Follow-up Phase

    Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  24. Percentage of Participants Reporting MAEs During the Entire Study

    Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

    MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.

  25. Percentage of Participants Reporting Immediate AEs After Vaccination 1

    Time frame: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)

    Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.

  26. Percentage of Participants Reporting Immediate AEs After Vaccination 2

    Time frame: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)

    Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.

  27. Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase

    Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  28. Percentage of Participants With NDCMC During the Follow-up Phase

    Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  29. Percentage of Participants With NDCMC During the Entire Study

    Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

    A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

  30. Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase

    Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

    An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 20, 2021
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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