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Investigating the Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba)

NCT02569632 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2021-02-02

Study results available
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Summary

This study will investigate the breadth of protection against meningococcal disease in humans immunized with a newly FDA approved meningococcal B vaccine, trade name "Trumenba®" manufactured by Pfizer Vaccines. As a secondary goal the investigators will investigate underlying mechanisms by which human anti-FHbp antibodies elicit complement-mediated bactericidal activity.

Conditions

  • Meningococcal Infections

Interventions

BIOLOGICAL

Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)

All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER

  • UCSF Benioff Children's Hospital Oakland

    lead OTHER

Principal Investigators

  • Dan Granoff, MD · Children's Hospital Oakland Research Institute, Center for Immunobiology and Vaccine Development

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02569632 on ClinicalTrials.gov