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

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ClinicalTrials.gov Identifier: NCT02305446
Recruitment Status : Completed
First Posted : December 2, 2014
Results First Posted : November 2, 2015
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meningitis, Meningococcal, Serogroup B Biological: Meningococcal (group B) multicomponent recombinant adsorbed vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 3b, Open Label, Uncontrolled, Single-arm, Single-centre Study to Evaluate the Safety of Two Doses of Novartis Meningococcal Group B Vaccine When Administered to Healthy Adults From 18 to 50 Years of Age and to Collect Blood Donations to Develop Vaccines Against Neisseria Meningitidis
Study Start Date : December 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rMenB+OMV NZ
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Biological: 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.
Other Name: rMenB+OMV NZ




Primary Outcome Measures :
  1. Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67) ]
    Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.


Other Outcome Measures:
  1. Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. [ Time Frame: Study day 1 blood sample was drawn between day -5 and day 1. Postvaccination 2 blood sample was drawn between day 23 and day 37 postvaccination 2. ]
    The number of identified healthy adult volunteers with pre and postvaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02305446


Locations
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Poland
01, Novartis Investigational Site
Krakow, Poland
Sponsors and Collaborators
Novartis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT02305446     History of Changes
Other Study ID Numbers: V72_74
2014-002972-95 ( EudraCT Number )
First Posted: December 2, 2014    Key Record Dates
Results First Posted: November 2, 2015
Last Update Posted: January 5, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs