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

NCT04893811

Last updated date
Study Location
Jacobi Medical Center
Bronx, New York, 10461, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ?10 Years of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE Biological: Trumenba
Bivalent recombinant lipoprotein 2086 vaccine
Study Arms  ICMJE Experimental: Single Arm
Bivalent recombinant lipoprotein 2086 vaccine
Intervention: Biological: Trumenba
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2024
Estimated Primary Completion Date May 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04893811
Other Study ID Numbers  ICMJE B1971060
2018-002588-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP