Trial Outcomes & Findings for Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ. (NCT NCT02305446)

NCT ID: NCT02305446

Last Updated: 2016-01-05

Results Overview

Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 55 participants
• Primary outcome timeframe: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)
• Results posted on: 2016-01-05

Participant Flow

Subjects will be enrolled at one site in Poland from December 2014 to February 2015.

All enrolled subjects will be included in the trial and assigned to the same treatment group.

Participant milestones

Measure	rMenB+OMV NZ Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Overall Study STARTED	55
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	rMenB+OMV NZ Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	rMenB+OMV NZ n=55 Participants Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Age, Continuous	27.2 YEARS STANDARD_DEVIATION 6.932 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: From day 1 to day 7 after each vaccination (Vaccination 1: Day 1 to Day 7; Vaccination 2: Day 61 to Day 67)

Population: Analysis were evaluated on the Unsolicited Safety Set

Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.

Outcome measures

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

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Population: The analysis was performed on the all enrolled dataset.

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.

Outcome measures

Measure	rMenB+OMV NZ n=55 Participants Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. Study Day 1 Blood Sample	55 Participants
Number of Adult Volunteers Whose Blood Can be Used as a Reference in Serum Bactericidal Activity (SBA) Test. Postvaccination 2 Blood Sample	50 Participants

Adverse Events

rMenB+OMV NZ

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	rMenB+OMV NZ n=55 participants at risk Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
Nervous system disorders MULTIPLE SCLEROSIS	1.8% 1/55 • Number of events 1 • Safety was assessed from the day of first vaccination (Day 1) until and inclusive the day of study termination (pre-planned at Day 91). 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.

Other adverse events

Adverse event data not reported

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60