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

Meningitis, Meningococcal, Serogroup B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305446
• Other study ID #: V72_74
• Secondary ID: 2014-002972-95
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2014
• Last updated: December 3, 2015
• Start date: December 2014
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis, Meningococcal
• Meningitis, Meningococcal, Serogroup B

Intervention

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.

Locations

Country	Name	City	State
Poland	01, Novartis Investigational Site	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.	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.	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.	No
Primary	Number of Subjects Reporting Unsolicited Adverse Events (AEs).	Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.	From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)	No