Clinical Trial Results:
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
Summary
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EudraCT number |
2014-002972-95 |
Trial protocol |
PL |
Global end of trial date |
24 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Feb 2016
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First version publication date |
18 Feb 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V72_74
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02305446 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Novartis Pharma Services A.G.
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Sponsor organisation address |
Fabrikstrasse 2, Basel, Switzerland, 4056
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Public contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Apr 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To establish a control sera panel using pre and post-vaccination blood donations to be used as a reference in SBA test.
To assess the safety of two doses of rMenB+OMV NZ in healthy adult subjects.
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Protection of trial subjects |
This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonization (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, including the European Directive 2001/20/EC, Novartis codes on the protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Dec 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Poland: 55
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Worldwide total number of subjects |
55
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EEA total number of subjects |
55
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
55
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at one site in Poland from December 2014 to February 2015. | ||||||||||
Pre-assignment
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Screening details |
All enrolled subjects were included in the trial and assigned to the same treatment group. | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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rMenB+OMV NZ | ||||||||||
Arm description |
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Meningococcal (group B) multicomponent recombinant adsorbed vaccine
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Investigational medicinal product code |
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Other name |
rMenB+OMV NZ
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
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Baseline characteristics reporting groups
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Reporting group title |
rMenB+OMV NZ
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Reporting group description |
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
rMenB+OMV NZ
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Reporting group description |
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule. | ||
Subject analysis set title |
All Enrolled Set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All screened subjects who provide informed consent and provide demographic and/or other baseline screening measurements, regardless of the subject’s vaccination status in the trial, and receive a subject ID.
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Subject analysis set title |
Unsolicited Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects in the Exposed Set with post-vaccination unsolicited adverse event data.
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End point title |
1. Number of Subjects Reporting Unsolicited AEs [1] | ||||||||||||||||||||||||||
End point description |
Safety was assessed as the number of the subjects who reported unsolicited AEs following vaccination.
Analysis were evaluated on the Unsolicited Safety Set.
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End point type |
Primary
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End point timeframe |
From day 1 to day 7 after each vaccination
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analyses not applicable. |
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No statistical analyses for this end point |
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End point title |
2. Number of Adult Volunteers Whose Blood Can be Used as a Reference in SBA Test. | ||||||||||
End point description |
The number of identified healthy adult volunteers with pre and post-vaccination blood donations were summarized to establish a control sera panel to be used as a reference in SBA test.
The analysis was performed on the all enrolled dataset.
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End point type |
Other pre-specified
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End point 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.
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Safety was assessed from the day of first vaccination (Day 1) until and inclusive the day of study termination (pre-planned at Day 91).
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Adverse event reporting additional 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.
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Assessment type |
Non-systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
rMenB+OMV NZ
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Reporting group description |
Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule. | ||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Statistical analyses not applicable. |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |