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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02305446
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 13.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• 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: Dec 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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 Names: rMenB+OMV NZ

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting Unsolicited Adverse Events (AEs). [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	01, Novartis Investigational Site	Krakow		Poland

Sponsors and Collaborators

• Novartis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT02305446
• Other Study ID Numbers: V72_74; 2014-002972-95
• First Posted: Dec 2, 2014
• Last Update Posted: Jan 5, 2016
• Last Verified: Dec 1, 2015

• Additional relevant MeSH terms: Meningitis, Meningococcal; Meningitis

Study Results

Participant Flow

Recruitment Details	Subjects will be enrolled at one site in Poland from December 2014 to February 2015.
Pre-assignment Detail	All enrolled subjects will be included in the trial and assigned to the same treatment group.

Arm/Group Title	rMenB+OMV NZ
Arm/Group Description	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Period Title: Overall Study
STARTED	55
COMPLETED	54
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	rMenB+OMV NZ
Arm/Group Description	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Overall Participants	55
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	27.2 (6.932)
Sex: Female, Male (Count of Participants)
Female	27 49.1%
Male	28 50.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Description	Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
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)

Outcome Measure Data

Analysis Population Description

Analysis were evaluated on the Unsolicited Safety Set

Arm/Group Title	rMenB+OMV NZ
Arm/Group Description	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Measure Participants	55
Any Serious Adverse Events (SAEs) (vaccination 1)	0
Any Serious Adverse Events (SAEs) (vaccination 2)	0
At least possibly related SAEs (vaccination 1)	0
At least possibly related SAEs (vaccination 2)	0
AEs leading to premature withdrawal (vaccination1)	0
AEs leading to premature withdrawal (vaccination2)	0
Medically attended AEs (vaccination 1)	0
Medically attended AEs (vaccination 2)	0
AESIs (AEs of Special Interest) (vaccination 1)	0
AESIs (AEs of Special Interest) (vaccination 2)	0

2. Other Pre-specified Outcome

Title	Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test.
Description	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.
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.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the all enrolled dataset.

Arm/Group Title	rMenB+OMV NZ
Arm/Group Description	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Measure Participants	55
Study Day 1 Blood Sample	55 100%
Postvaccination 2 Blood Sample	50 90.9%

Adverse Events

Time Frame	Safety was assessed from the day of first vaccination (Day 1) until and inclusive the day of study termination (pre-planned at Day 91).
Adverse Event Reporting Description	The analyses for unsolicited adverse events were done on the safety population. This study collects: throughout the study, any SAEs, AEs leading to withdrawal, AESI and medically attended AEs.
Arm/Group Title	rMenB+OMV NZ
Arm/Group Description	Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
All Cause Mortality
	rMenB+OMV NZ
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	rMenB+OMV NZ
	Affected / at Risk (%)	# Events
Total	1/55 (1.8%)
Nervous system disorders
MULTIPLE SCLEROSIS	1/55 (1.8%)	1
Other (Not Including Serious) Adverse Events
	rMenB+OMV NZ
	Affected / at Risk (%)	# Events
Total	0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.