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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Meningitis, Meningococcal, Serogroup B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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rMenB+OMV NZ

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

Group Type EXPERIMENTAL

Meningococcal (group B) multicomponent recombinant adsorbed vaccine

Intervention Type BIOLOGICAL

One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

Interventions

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Meningococcal (group B) multicomponent recombinant adsorbed vaccine

One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.

Intervention Type BIOLOGICAL

Other Intervention Names

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rMenB+OMV NZ

Eligibility Criteria

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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;

4\. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes