Trial Outcomes & Findings for A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults (NCT NCT01478347)

Results Overview

The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Day 1 to day 91

Results posted on

2015-03-27

Participant Flow

Subjects were recruited from a single center.

All enrolled subjects participated in the study.

Participant milestones

Participant milestones
Measure	rMenB+OMV NZ Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
Visit 1-Visit 3 (Day 0-91) - Part I STARTED	18
Visit 1-Visit 3 (Day 0-91) - Part I COMPLETED	17
Visit 1-Visit 3 (Day 0-91) - Part I NOT COMPLETED	1
Visit 4-Visit 7 (Day 151-331) - Part II STARTED	12
Visit 4-Visit 7 (Day 151-331) - Part II COMPLETED	4
Visit 4-Visit 7 (Day 151-331) - Part II NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	rMenB+OMV NZ Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
Visit 1-Visit 3 (Day 0-91) - Part I Lost to Follow-up	1
Visit 4-Visit 7 (Day 151-331) - Part II Lost to Follow-up	4
Visit 4-Visit 7 (Day 151-331) - Part II Withdrawal by Subject	4

Baseline Characteristics

A Phase 3b Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered in Healthy At-risk Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rMenB+OMV NZ n=18 Participants Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study. In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to "lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data.
Age, Customized rMenB (part I; N=18)	34.5 years STANDARD_DEVIATION 5.7 • n=93 Participants
Age, Customized rMenB (part II; N=11)	34.1 years STANDARD_DEVIATION 5.6 • n=93 Participants
Sex/Gender, Customized rMenB( part I; female)	13 subjects n=93 Participants
Sex/Gender, Customized rMenB( part I; male)	5 subjects n=93 Participants
Sex/Gender, Customized rMenB( part II; female)	8 subjects n=93 Participants
Sex/Gender, Customized rMenB( part II; male)	3 subjects n=93 Participants

PRIMARY outcome

Timeframe: Day 1 to day 91

Population: This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part one of the study.

The number of subjects with serious adverse events (SAE), medically attended adverse events and adverse events (AEs) leading to premature withdrawal, following two injections of rMenB+OMV NZ vaccine are reported.

Outcome measures

Outcome measures
Measure	rMenB+OMV NZ n=18 Participants Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. Medically attended AEs	2 subjects
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. At least possibly related medically	0 subjects
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. SAEs	0 subjects
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. At least possibly related SAEs	0 subjects
Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91. Premature withdrawals due to AEs	0 subjects

PRIMARY outcome

Timeframe: Day 92 to day 331

Population: This analysis was done on the safety set population i.e all subjects in the exposed set with unsolicited adverse event data for part two of the study.

The number of subjects (who had received two injections of rMenB + OMV NZ vaccine in the part I of this study) reporting unsolicited AEs during the safety follow-up in part II of the study, are reported. Unsolicited AEs in part two of the study include - AEs considered to be related to blood draw procedure and all SAEs.

Outcome measures

Outcome measures
Measure	rMenB+OMV NZ n=11 Participants Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study). SAEs	0 subjects
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study). All AEs	0 subjects
Number of Subjects (Who Had Received Two Injections of rMenB+OMV NZ Vaccine in Part I of This Study) Reporting Unsolicited Adverse Events During Safety Follow-up (Part II of the Study). At least possibly related SAEs	0 subjects

Adverse Events

rMenB+OMV NZ

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rMenB+OMV NZ n=18 participants at risk Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
Infections and infestations Pharyngitis	5.6% 1/18 • Number of events 1 • All serious adverse events and other unsolicited adverse events collected from Day 1 to Day 331 (throughout the study) for subjects who participated in both part I and II of the study, are reported.
Infections and infestations Urinary tract infection	5.6% 1/18 • Number of events 1 • All serious adverse events and other unsolicited adverse events collected from Day 1 to Day 331 (throughout the study) for subjects who participated in both part I and II of the study, are reported.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Other disclosure agreement: the terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial
Publication restrictions are in place

Restriction type: OTHER