Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningitis, Meningococcal, Serogroup B

Treatments: Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02305446

V72_74

2014-002972-95 (EudraCT Number)

Details and patient eligibility

About

The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the Meningococcal Group B Vaccine in other studies.

Enrollment: 55 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Individuals of 18 through 50 years of age on the day of informed consent;
2. Individuals who had voluntarily given written informed consent after the nature of the study had been explained according to local regulatory requirements, prior to study entry;
3. Individuals who could comply with study procedures including follow-up;
4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method.

Exclusion criteria

1. Progressive, unstable or uncontrolled clinical conditions;

2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study;

3. Abnormal function of the immune system;

4. Chronic clinical significant conditions;

5. Been administered any group B meningococcal vaccine at any time prior to informed consent; 5. Current or previous, confirmed or suspected disease caused by N.meningitidis.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

rMenB+OMV NZ

Experimental group

Description:

Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule

Treatment:

Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine