Clinical trial NCT04893811: Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Vaccine
Keywords: Meningococcal Vaccine
Meningitis Vaccine
Asplenia
Sickle cell anemia
Complement deficiencies
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 53
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: Baseline (Before Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2
timeFrame: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1
timeFrame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2
timeFrame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1
timeFrame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2
timeFrame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1
timeFrame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2
timeFrame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1
timeFrame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting AEs During 30 Days After Vaccination 2
timeFrame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting AEs During 30 Days After Any Vaccination
timeFrame: 30 Days after any Vaccination
measure: Percentage of Participants Reporting AEs During the Vaccination Phase
timeFrame: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1
timeFrame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2
timeFrame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination
timeFrame: 30 Days after any Vaccination
measure: Percentage of Participants Reporting SAEs During the Vaccination Phase
timeFrame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
measure: Percentage of Participants Reporting SAEs During the Follow-up Phase
timeFrame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
measure: Percentage of Participants Reporting SAEs During the Entire Study
timeFrame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
measure: Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1
timeFrame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2
timeFrame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination
timeFrame: 30 Days after any Vaccination
measure: Percentage of Participants Reporting MAEs During the Vaccination Phase
timeFrame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
measure: Percentage of Participants Reporting MAEs During the Follow-up Phase
timeFrame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
measure: Percentage of Participants Reporting MAEs During the Entire Study
timeFrame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
measure: Percentage of Participants Reporting Immediate AEs After Vaccination 1
timeFrame: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)
measure: Percentage of Participants Reporting Immediate AEs After Vaccination 2
timeFrame: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)
measure: Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
timeFrame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
measure: Percentage of Participants With NDCMC During the Follow-up Phase
timeFrame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
measure: Percentage of Participants With NDCMC During the Entire Study
timeFrame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
measure: Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase
timeFrame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Secondary outcomes:
Other outcomes:
Locations:
city: Brno 2
country: Czechia
facility: Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Bydgoszcz
country: Poland
facility: IN-VIVO Sp. z o.o.
city: Krakow
country: Poland
facility: Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
city: Adana
country: Turkey
facility: Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
state: Yüreği̇r
city: Adana
country: Turkey
facility: Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
state: Yüreği̇r
city: Adana
country: Turkey
facility: Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
city: Adana
country: Turkey
facility: Acibadem Adana Hastanesi
city: Adana
country: Turkey
facility: Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin Universitesi Tip Fakultesi Hastanesi
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: