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

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ClinicalTrials.gov Identifier: NCT01478347
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : March 6, 2015
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Disease
Meningococcal Meningitis
Intervention Biological: Recombinant meningococcal B + OMV NZ
Enrollment 18
Recruitment Details Subjects were recruited from a single center.
Pre-assignment Details All enrolled subjects participated in the study.
Arm/Group Title rMenB+OMV NZ
Hide Arm/Group Description 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.
Period Title: Visit 1-Visit 3 (Day 0-91) - Part I
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Period Title: Visit 4-Visit 7 (Day 151-331) - Part II
Started 12
Completed 4
Not Completed 8
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             4
Arm/Group Title rMenB+OMV NZ
Hide Arm/Group Description

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 Only 11 subjects (one subject was withdrawn after visit 3 due to "lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures, were administered two injections of rMenB + OMV NZ vaccine, 2 months apart in part I (Visit 1-Visit 3). In part II (Visit 4-Visit 7), subjects were re-enrolled for optional blood draws and safety follow-up.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
rMenB (part I; N=18) 34.5  (5.7)
rMenB (part II; N=11) 34.1  (5.6)
[1]
Measure Description: Of the 18 subjects enrolled for part I of the study, only 12 subjects continued participation into protocol part II of the study. Of these, 11 subjects were included in safety set.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 18 participants
rMenB( part I; female) 13
rMenB( part I; male) 5
rMenB( part II; female) 8
rMenB( part II; male) 3
1.Primary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events, Following Vaccination With Two Injections of rMenB+OMV NZ Vaccine Between Day 1 Through Day 91.
Hide Description 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.
Time Frame Day 1 to day 91
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title rMenB+OMV NZ
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: subjects
Medically attended AEs 2
At least possibly related medically 0
SAEs 0
At least possibly related SAEs 0
Premature withdrawals due to AEs 0
2.Primary Outcome
Title 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).
Hide Description 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.
Time Frame Day 92 to day 331
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title rMenB+OMV NZ
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: subjects
All AEs 0
SAEs 0
At least possibly related SAEs 0
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title rMenB+OMV NZ
Hide Arm/Group Description 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.
All-Cause Mortality
rMenB+OMV NZ
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
rMenB+OMV NZ
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rMenB+OMV NZ
Affected / at Risk (%) # Events
Total   2/18 (11.11%)    
Infections and infestations   
Pharyngitis * 1  1/18 (5.56%)  1
Urinary tract infection * 1  1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01478347     History of Changes
Other Study ID Numbers: V72_37
First Submitted: November 21, 2011
First Posted: November 23, 2011
Results First Submitted: February 20, 2015
Results First Posted: March 6, 2015
Last Update Posted: March 27, 2015