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A Phase 3b, Single-Center, Open-label Study to Assess the Immunogenicity and Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy At-Risk Adults Aged 18 to 65 Years Inclusive.

NCT01911221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-06-08

Study results available
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Summary

The study will evaluate the immunogenicity and safety of the rMenB+OMV NZ in an adult population potentially at risk for meningococcal disease (e.g. lab workers).

Conditions

  • Prevention of the Meningococcal Disease

Interventions

BIOLOGICAL

rMenB+OMV NZ

Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain

Sponsors & Collaborators

Principal Investigators

  • Novartis Vaccines and Diagnostics · Novartis Vaccines

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT01911221 on ClinicalTrials.gov