CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)biological
Likely dose
Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02569632
NCT02569632Phase 4Completed
CompareCT.gov

Immunogenicity of a U.S.-Licensed Meningococcal Serogroup B Vaccine (Trumenba) in Adults at Increased Risk of Meningococcal Disease Because of Occupational Exposure

UCSF Benioff Children's Hospital Oakland·interventional·Posted Oct 7, 2015·Updated Feb 2, 2021

In Brief

A Phase 4 clinical trial evaluating Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals) for Meningococcal Infections. Completed, enrolled 18 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeningococcal Infections
CountriesUnited States
CollaboratorsUniversity of Massachusetts, Worcester

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 7, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.7 years ago

Interventions

Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)biological

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.