A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

NCT03135834

Last updated date
Study Location
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235, United States
Contact
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
10-25 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subject aged >=10 and <26 years at the time of enrollment.

- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

- Negative urine pregnancy test for all female subjects.

- Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

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 or purely polysaccaride
(nonconjugate) meningococcal vaccine.


- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.


- A known or suspected defect of the immune system that would prevent an immune response
to the vaccine, such as subjects with congenital or acquired defects in B cell
function, those receiving chronic systemic (oral, intravenous, or intramuscular)
corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
United States with terminal complement deficiency are excluded from participation in
this study.


- Significant neurological disorder or history of seizure (excluding simple febrile
seizure).


- Current chronic use of systemic antibiotics.


- Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.


- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

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Meningococcal VaccineA Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age. NCT03135834
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  6. Harrisburg, Arkansas
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  23. Omaha, Nebraska
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  25. Endwell, New York
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  27. Raleigh, North Carolina
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  29. Cleveland, Ohio
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  32. Oklahoma City, Oklahoma
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  34. Charleston, South Carolina
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  36. Mount Pleasant, South Carolina
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  39. Bristol, Tennessee
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  39. Omaha, Nebraska
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  41. Mineola, New York
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  43. Mineola, New York
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  47. Raleigh, North Carolina
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  56. Kingsport, Tennessee
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  60. Charlottesville, Virginia
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  72. Odolena Voda,
  73. Pardubice,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Official Title  ICMJE A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE
Brief Summary This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal pentavalent vaccine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Meningococcal Vaccine
Intervention  ICMJE
  • Biological: MenABCWY
    N meningitidis group A, B, C, W, and Y vaccine
  • Biological: Saline
    Placebo
  • Biological: rLP2086
    Bivalent recombinant lipoprotein 2086 vaccine
  • Biological: MenACWY-CRM
    meningococcal group A, C, W-135, and Y conjugate vaccine
Study Arms  ICMJE
  • Experimental: Group 1 (ACWY Naive subjects, MenABCWY/Saline)
    ACWY Naive subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)
    ACWY Naive subjects, rLP2086/MenACWY-CRM
    Interventions:
    • Biological: rLP2086
    • Biological: MenACWY-CRM
  • Experimental: Group 3 (ACWY Experienced subjects, MenABCWY/Saline)
    ACWY Experienced subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)
    ACWY Experienced subjects, rLP2086/MenACWY-CRM
    Interventions:
    • Biological: rLP2086
    • Biological: MenACWY-CRM
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
1590
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 18, 2023
Estimated Primary Completion Date January 18, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subject aged >=10 and <26 years at the time of enrollment.
  • Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • Negative urine pregnancy test for all female subjects.
  • Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

Exclusion Criteria:

  • Previous vaccination with any meningococcal serogroup B or purely polysaccaride (nonconjugate) meningococcal vaccine.
  • Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
  • Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • Current chronic use of systemic antibiotics.
  • Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
  • Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Czechia,   Finland,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03135834
Other Study ID Numbers  ICMJE B1971057
2016-004421-17 ( 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 November 2019

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