Clinical Trial Results:
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
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Summary
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EudraCT number |
2015-000979-27 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Feb 2016
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First version publication date |
27 Feb 2016
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Other versions |
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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 |
V102_16
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02140762 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics
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Sponsor organisation address |
via Fiorentina 1, Siena, Italy, 53100
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Feb 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Feb 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 assess the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US Neisseria meningitidis (N. meningitidis) serogroup B invasive disease strains as measured by bactericidal activity at 1:4 dilution using endogenous complement human Serum Bactericidal Assay (enc-hSBA) at one month after the two vaccinations, when compared to a single dose of MenACWY.
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Protection of trial subjects |
This clinical study was designed and shall be implemented and reported in accordance with the International Counsil for Harmonisation (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice, with applicable local regulations including European Directive 2001/20/EC, US Code of Federal Regulations Title 21, and Japanese Ministry of Health, Labor, and Welfare, Novartis codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
Eligible subjects may only be included in the study after providing written informed Consent.
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Background therapy |
- | ||
Evidence for comparator |
MenACWY was used as active-comparator to evaluate the effectiveness of MenABCWY. | ||
Actual start date of recruitment |
29 May 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 |
United States: 305
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Worldwide total number of subjects |
305
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EEA total number of subjects |
0
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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) |
182
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Adolescents (12-17 years) |
109
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Adults (18-64 years) |
14
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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 recruited from 8 study sites in USA. | |||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
All enrolled subjects were included in the trial. | |||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Assessor | |||||||||||||||||||||||||||
Blinding implementation details |
Observer blind
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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MenABCWY | |||||||||||||||||||||||||||
Arm description |
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenABCWY
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Investigational medicinal product code |
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Other name |
MenACWY conjugate combined with rMenB + OMV
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Pharmaceutical forms |
Powder for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL dose in the deltoid area of the non dominant arm.
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Arm title
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Placebo/MenACWY | |||||||||||||||||||||||||||
Arm description |
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2. | |||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||
Investigational medicinal product name |
MenACWY
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Investigational medicinal product code |
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Other name |
Menveo
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL dose in the deltoid area of non dominant arm.
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Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
Saline solution
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL saline solution in the deltoid area of non dominant arm.
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Baseline characteristics reporting groups
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Reporting group title |
MenABCWY
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Reporting group description |
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MenABCWY
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Reporting group description |
Subjects received one dose of MenABCWY vaccine at visit day 1 and a second dose at visit month 2. | ||
Reporting group title |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of placebo at visit day 1 and one dose of MenACWY vaccine at visit month 2. | ||
Subject analysis set title |
All enrolled set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All screened subjects who provided informed consent and received a subject ID, regardless of the subject’s randomization and treatment status in the trial.
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Subject analysis set title |
Exposed Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects in the All Enrolled Set who received a study vaccination.
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Subject analysis set title |
Full Analysis Set (FAS) effectiveness (month 3)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects in the All Enrolled Set who: received a study vaccination and provided evaluable serum sample with enc-hSBA for at least one N. meningitidis serogroup B invasive disease strain at one month after the 2-dose series (Visit Month 3).
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Subject analysis set title |
Full Analysis Set (FAS) immunogenicity (month 3)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects in the All Enrolled Set who received a study vaccination and provided evaluable serum samples respectively at one month post-second vaccination (Visit Month 3) whose immunogenicity assay result is available for at least one N. meningitidis serogroup B test strain or serogroups A, C, W or Y.
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Subject analysis set title |
Solicited Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects in the All Exposed Set who have provided any solicited adverse event data and/or other indicators or reactogenicity.
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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 All Exposed Set who have post-vaccination unsolicited adverse event records.
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Subject analysis set title |
Overall Safety Set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects in the All Exposed Set who have either post-vaccination unsolicited adverse event or reactogenicity records.
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End point title |
Percentage of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitidis (N. meningitidis) serogroup B strain at one month after the second injection | ||||||||||||
End point description |
The combined percentage of subjects without bactericidal activity at 1:4 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:4 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalised linear model.
Analysis was done on FAS effectiveness (month 3).
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End point type |
Primary
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End point timeframe |
One month after the second vaccination (month 3)
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Statistical analysis title |
Combined Serogroup B Strains Vaccine Effectiveness | ||||||||||||
Statistical analysis description |
H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%.
If the lower limit of 95% CI for VE is > 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the 2nd injection for each strain is defined as [1 - (% of subjects without bactericidal activity at 1:4 dilution in MenABCWY group / % of subjects without bactericidal activity at 1:4 dilution in MenACWY group)] x 100. The combined VE across all strains was computed by mean of a generalized linear model.
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Comparison groups |
Placebo/MenACWY v MenABCWY
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Number of subjects included in analysis |
274
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Analysis specification |
Pre-specified
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Analysis type |
superiority [1] | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
Generalized Linear Model | ||||||||||||
Parameter type |
Vaccine Effectiveness | ||||||||||||
Point estimate |
67
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
65 | ||||||||||||
upper limit |
69 | ||||||||||||
| Notes [1] - VE is based on the relative risk (RR). The Poisson Distibution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center). |
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End point title |
Percentages of Subjects Without Bactericidal Activity at 1:8 dilution against each US N. meningitidis serogroup B strain at one month after the second injection | ||||||||||||
End point description |
The combined percentage of subjects without bactericidal activity at 1:8 dilution using the endogenous complement human Serum Bactericidal Assay (enc-hSBA) across all strains in MenABCWY group and MenACWY group is reported at one month after the second injection. The percentage of subjects without bactericidal activity at 1:8 dilution was used to assess the effectiveness of two doses of MenABCWY vaccine when compared to one dose of Men ACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains. Least Square (LS)-mean computed from the generalized linear model.
Analysis was done on FAS effectiveness (month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3)
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Statistical analysis title |
Combined Serogroup B Strains Vaccine Effectiveness | ||||||||||||
Statistical analysis description |
H0 (Null Hypothesis): Vaccine Effectiveness (VE) ≤10%.
If the lower limit of the 95% CI for VE is > 10% the null hypothesis is to be rejected and effectiveness declared. The VE at 1 month after the second injection for each strain is defined as [1 -(% of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/% of subjects without bactericidal activity at 1:8 dilution in MenACWY group)]x100. The combined VE across all strains was computed by mean of a generalized linear model.
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Comparison groups |
MenABCWY v Placebo/MenACWY
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Number of subjects included in analysis |
274
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Analysis specification |
Pre-specified
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Analysis type |
superiority [2] | ||||||||||||
P-value |
< 0.0001 | ||||||||||||
Method |
Generalized Linear Model | ||||||||||||
Parameter type |
Vaccine Effectiveness | ||||||||||||
Point estimate |
46
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
43 | ||||||||||||
upper limit |
49 | ||||||||||||
| Notes [2] - VE is based on the relative risk (RR). The Poisson Distribution and Log Link options were used in the generalized linear model to compute the log10 RR and the corresponding confidence interval. Fixed effects:treatment group, strain (and center). |
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End point title |
Percentages of strains with Vaccine Effectiveness (VE) values corresponding to predefined ranges at 1:4 dilution at one month after the second vaccination [3] | ||||||||||||||||||||||||||||||||
End point description |
Percentages of strains with VE values from 0% through <10%, from 10% through < 30%, from 30% through < 60%, from 60% through 100% at 1:4 dilution at one month after the second vaccination against each of the endemic US N. meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model.
The effectiveness of two doses of MenABCWY vaccine was compared to one dose of Men ACWY vaccine.
Analysis was done on FAS effectiveness (month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3).
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No statistical analysis was aassociated to this endpoint. |
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| Notes [4] - Number of strains tested for VE per study group |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Percentages of strains with VE values corresponding to predefined ranges at 1:8 dilution at one month after the second vaccination [5] | ||||||||||||||||||||||||||||||||
End point description |
Percentages of strains with VE values from 0% through <10%, from 10% through <30%, from 30% through <60%, 60% through 100% at 1:8 dilution at one month after the second vaccination against each of the endemic US N. meningitidis serogroup B strains. Each individual strain data was analysed separately with treatment group as only independent variable in the model. The effectiveness of two doses of MenABCWY vaccine was compared to one dose of Men ACWY vaccine.
Analysis was done on FAS effectiveness (Month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3)
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| Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: No statistical analysis was aassociated to this endpoint. |
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| Notes [6] - Number of strains tested for VE per study group |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
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End point title |
Percentages of N. meningitidis serogroup B invasive disease strains killed at 1:4 and 1:8 dilutions, for each subject | ||||||||||||||||||||||||
End point description |
The mean percentage of N. meningitidis serogroup B invasive disease strains killed by each subject, at 1:4 and 1:8 dilutions at one month after the 2-dose vaccination series is reported.
Analysis was done on FAS effectiveness (month 3).
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End point type |
Secondary
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End point timeframe |
Baseline, one month after second vaccination (month 3)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentages of subjects with enc-hSBA titer ≥ 1:4 and enc-hSBA titer ≥ 1:8 at one month after the 2-dose vaccination series | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of two doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA titer ≥ 1:8 against four N. meningitidis serogroup B test strains at one month after the 2-dose vaccination series is reported.
Analysis was done on the FAS immunogenicity (month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains | ||||||||||||||||||||||||
End point description |
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs against serogroup B test strains, at one month after the 2-dose vaccination series.
Analysis was done on the FAS immunogenicity (month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
hSBA Geometric Mean Titers (GMTs) Against the N. Meningitidis Serogroups A,C,W,Y | ||||||||||||||||||||||||
End point description |
The immunogenicity of two doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of hSBA GMTs to serogroups A, C, W, and Y, at one month after the 2-dose vaccination series.
Analysis was done on FAS Immunogenicity (Month 3).
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End point type |
Secondary
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End point timeframe |
One month after the second vaccination (month 3)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Reactogenicity was presented in terms of number of subjects reporting solicited local and systemic AEs and other indicators.
Analysis was done on Solicited Safety Set.
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End point type |
Secondary
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End point timeframe |
From day 1 (6 hours) until day 7 after any vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentages of subjects reporting unsolicited AEs | |||||||||||||||||||||||||||
End point description |
Percentages of subjects reporting unsolicited AEs including serious adverse events (SAEs).
Analysis was done on the unsolicited safety set. Analysis for AEs leading to withdrawal was done on All Enrolled Set population.
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End point type |
Secondary
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End point timeframe |
From day 1 to day 30 after any vaccination for any unsolicited AE. From day 1 to study termination (day 181) for all other categories.
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Solicited adverse events (AEs): from Day 1 to Day 7 of each study vaccination. Unsolicited AEs from Day 1 to Day 30 after each vaccination. Serious AEs, medically attended AEs, AEs leading to withdrawal were collected for the whole duration of the study.
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Adverse event reporting additional description |
Data are presented in terms of number of subjects reporting AEs. Data are presented in terms of number of subjects reporting AEs with a frequency > 5% in at least one group.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of placebo at day 1 and one dose of MenACWY vaccine after 2 months | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenABCWY
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Reporting group description |
Subjects received one dose of MenABCWY vaccine at day 1 and a second dose after 2 months | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Not all subjects in the Exposed Population provided safety information. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Mar 2014 |
The protocol has been amended:
to reflect the revised plan to restrict access to subject group assignments for both of the planned final analyses and to generate individual data listings with subject group assignments only after full unblinding of the extension study (V102_16E1);
to clarify elements of the Interactive Response Technology randomization procedures;
to address the new End of Study definition in compliance with the Novartis Quality Manual and the Corporate Data Disclosure Policy. |
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03 Feb 2015 |
The protocol has been amended:
to replace the NadA M01-0240364 strain with NadA strain 96217, in accordance to per Center for Biologics Evaluation and Research Office of Vaccines Research and Review (CBER) feedback on HT-hSBA validation plan;
to clarify that subjects should not have reportable protocol deviations leading to exclusion for period prior to Visit Month 3/Visit Month 6 (except for blood draws and serological results missing);
to revised definition and evaluation of protocol deviations, according to changes made to the Novartis Vaccines internal process of defining and evaluating protocol deviations. |
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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 | |||
