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

NCT04893811 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: B19710602018-002588-24
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 14

Brief 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.

Conditions

Meningococcal Vaccine

Keywords

Meningococcal Vaccine; Meningitis Vaccine; Asplenia; Sickle cell anemia; Complement deficiencies

Outcome Measures

Primary Outcomes (30)

• 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

  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.

  Baseline (Before Vaccination 1 on Day 1/Month 0)

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

  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.

  1 Month after Vaccination 2 (Vaccination 2 at Month 6)

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

  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).

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

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

  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).

  Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

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

  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).

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

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

  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).

  Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

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

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

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

  Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

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

  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.

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

• Percentage of Participants Reporting AEs During 30 Days After Vaccination 2

  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.

  30 Days after Vaccination 2 (Vaccination 2 at Month 6)

• Percentage of Participants Reporting AEs During 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.

  30 Days after any Vaccination

• Percentage of Participants Reporting AEs During the Vaccination Phase

  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.

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

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

  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.

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

• Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2

  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.

  30 Days after Vaccination 2 (Vaccination 2 at Month 6)

• Percentage of Participants Reporting SAEs During 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.

  30 Days after any Vaccination

• Percentage of Participants Reporting SAEs During the Vaccination Phase

  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.

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

• Percentage of Participants Reporting SAEs During the Follow-up Phase

  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.

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

• Percentage of Participants Reporting SAEs During the Entire Study

  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.

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

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

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

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

• Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2

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

  30 Days after Vaccination 2 (Vaccination 2 at Month 6)

• Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination

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

  30 Days after any Vaccination

• Percentage of Participants Reporting MAEs During the Vaccination Phase

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

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

• Percentage of Participants Reporting MAEs During the Follow-up Phase

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

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

• Percentage of Participants Reporting MAEs During the Entire Study

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

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

• Percentage of Participants Reporting Immediate AEs After Vaccination 1

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

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

• Percentage of Participants Reporting Immediate AEs After Vaccination 2

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

  30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)

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

  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.

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

• Percentage of Participants With NDCMC During the Follow-up Phase

  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.

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

• Percentage of Participants With NDCMC During the Entire Study

  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.

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

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

  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.

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

Study Arms (1)

Single Arm

EXPERIMENTAL

Bivalent recombinant lipoprotein 2086 vaccine

Biological: Trumenba

Interventions

Trumenba BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

Single Arm

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (14)

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

Brno, 613 00, Czechia

Location

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

Brno, 61300, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

IN-VIVO Sp. z o.o.

Bydgoszcz, 85-048, Poland

Location

Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

Krakow, 30-348, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, 00-728, Poland

Location

Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ

Warsaw, 01-809, Poland

Location

Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi

Adana, Yüreği̇r, 01120, Turkey (Türkiye)

Location

Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi

Adana, Yüreği̇r, Turkey (Türkiye)

Location

Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi

Adana, 01120, Turkey (Türkiye)

Location

Acibadem Adana Hastanesi

Adana, 01130, Turkey (Türkiye)

Location

Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi

Adana, 01240, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi

Ankara, 06230, Turkey (Türkiye)

Location

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, 33343, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Anemia, Sickle Cell; Hereditary Complement Deficiency Diseases

Interventions

MenB-FHbp vaccine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: PfizerClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-8007181021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: August 18, 2021
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CZ (3); PL (4); TU (7)