Clinical Trial Results:
A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose of GlaxoSmithKline Biologicals Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
Summary
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EudraCT number |
2015-001030-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
11 Jun 2015
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Results information
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Results version number |
v3(current) |
This version publication date |
07 Sep 2018
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First version publication date |
24 Jun 2016
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Other versions |
v1 , v2 |
Version creation reason |
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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 |
205232
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02285777 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart,, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.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 |
18 Jun 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
26 Mar 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jun 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 N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity at 1:4 dilution using enc-hSBA at one month after the 3-dose series, when compared to a single dose of MenACWY.
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Protection of trial subjects |
Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel. The measures of safety used in this study are routine clinical procedures. They include a close vigilance for, and stringent reporting of, selected local and systemic adverse events routinely monitored in vaccine clinical studies as indicators of reactogenicity. The period of observation for AEs extends from the time the subject signs informed consent until he or she completes the final study visit (Visit Month 4) or terminates the study early (whichever comes first).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 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 |
United States: 189
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Worldwide total number of subjects |
189
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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) |
81
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Adolescents (12-17 years) |
97
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Adults (18-64 years) |
11
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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 |
189 subjects were enrolled from 1 center in United States | ||||||||||||||||||
Pre-assignment
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Screening details |
An Interactive Response Technology (IRT) was used in the study. At Month 6 Visit of the parent study, IRT allocated the study vaccines (either MenABCWY or placebo) to the subject. Subject received either a 3rd dose of MenABCWY or one dose of a placebo, depending on their assigned vaccine group in parent study. | ||||||||||||||||||
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 |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | ||||||||||||||||||
Blinding implementation details |
Trial is observer-blinded. Observer-blind means that during the course of study, the subject, the parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint (e.g. safety and reactogenicity) will be unaware which vaccine was administered. The vaccine preparation and administration will be done by designated medical personnel who will not participate in any of the clinical study evaluations.
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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 Group | ||||||||||||||||||
Arm description |
Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
1 dose of 0.5 millilitres
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Arm title
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MenACWY Group | ||||||||||||||||||
Arm description |
Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
1 dose of 0.5 millilitres
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Baseline characteristics reporting groups
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Reporting group title |
MenABCWY Group
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Reporting group description |
Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY Group
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Reporting group description |
Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MenABCWY Group
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Reporting group description |
Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. | ||
Reporting group title |
MenACWY Group
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Reporting group description |
Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. |
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End point title |
Percentages of subjects without bactericidal activity at 1:4 dilution against each US Neisseria meningitides (N. meningitidis) serogroup B strain at 1 month after the 3-dose vaccination series. | |||||||||||||||
End point description |
The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 month after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the human Serum Bactericidal Assay (hSBA) against each strain in MenABCWY group and MenACWY group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Month 7)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination,& who provided evaluable serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 7.
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End point type |
Primary
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End point timeframe |
At Month 7 (1 month after the 3-dose vaccination series)
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Statistical analysis title |
Statistical analysis 1 | |||||||||||||||
Statistical analysis description |
The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage 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 |
MenABCWY Group v MenACWY Group
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Number of subjects included in analysis |
186
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||||||||
P-value |
= 0.0001 | |||||||||||||||
Method |
Generalized Linear Model | |||||||||||||||
Parameter type |
Vaccine Effectiveness | |||||||||||||||
Point estimate |
71
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
69 | |||||||||||||||
upper limit |
73 | |||||||||||||||
Notes [1] - Pre-specified. |
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End point title |
Percentages of subjects without bactericidal activity at 1:4 dilution against each US N. meningitidis serogroup B strain at 4 months after the 3-dose vaccination series. | |||||||||||||||
End point description |
The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 4 months after the 3-dose vaccination series was evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:4 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:4 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Month 10
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End point type |
Secondary
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End point timeframe |
At Month 10 (4 months after the 3-dose vaccination series)
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Statistical analysis title |
Statistical analysis 1 | |||||||||||||||
Statistical analysis description |
The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:4 dilution in MenABCWY group/percentage 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 |
MenABCWY Group v MenACWY Group
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Number of subjects included in analysis |
180
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Analysis specification |
Pre-specified
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Analysis type |
other [2] | |||||||||||||||
P-value |
= 0.0001 | |||||||||||||||
Method |
Generalized Linear Model | |||||||||||||||
Parameter type |
Vaccine Effectiveness | |||||||||||||||
Point estimate |
51
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
48 | |||||||||||||||
upper limit |
55 | |||||||||||||||
Notes [2] - Pre-specified. |
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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 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||
End point description |
The effectiveness of three doses of MenABCWY vaccine when compared to one dose of MenACWY vaccine against a panel of US N. meningitidis serogroup B invasive disease strains at 1 and 4 months after the 3-dose vaccination series were evaluated in terms of: the combined percentage of subjects without bactericidal activity at 1:8 dilution using the hSBA against each strain in MenABCWY Group and MenACWY Group. The data provided is an average of the percentage of subjects without bactericidal activity at 1:8 dilution across all 110 strains.Analysis was performed on FAS-Effectiveness (Months 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received subject ID & vaccination, & provided evaluable serum sample with the enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain at Months 7 & 10.
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End point type |
Secondary
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End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||
Statistical analysis description |
The Vaccine Effectiveness (VE) at 1 month after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 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 |
MenACWY Group v MenABCWY Group
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Number of subjects included in analysis |
186
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||||||||
P-value |
= 0.0001 | ||||||||||||||||||
Method |
Generalized Linear Model | ||||||||||||||||||
Parameter type |
Vaccine Effectiveness | ||||||||||||||||||
Point estimate |
51
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
48 | ||||||||||||||||||
upper limit |
54 | ||||||||||||||||||
Notes [3] - Pre-specified. |
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Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||
Statistical analysis description |
The Vaccine Effectiveness (VE) at 4 months after the 3-dose vaccination series for each strain is defined as [1 - (percentage of subjects without bactericidal activity at 1:8 dilution in MenABCWY group/percentage of subjects without bactericidal activity at 1:8 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 |
MenACWY Group v MenABCWY Group
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Number of subjects included in analysis |
186
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Analysis specification |
Pre-specified
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Analysis type |
other [4] | ||||||||||||||||||
P-value |
= 0.0001 | ||||||||||||||||||
Method |
Generalized Linear Model | ||||||||||||||||||
Parameter type |
Vaccine Effectiveness | ||||||||||||||||||
Point estimate |
24
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Confidence interval |
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level |
95% | ||||||||||||||||||
sides |
2-sided
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lower limit |
20 | ||||||||||||||||||
upper limit |
28 | ||||||||||||||||||
Notes [4] - Pre-specified. |
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End point title |
Percentages of US N. meningitidis serogroup B strains killed at 1:4 and 1:8 dilutions at 1 and 4 months after the 3-dose vaccination series | ||||||||||||||||||||||||||||||
End point description |
The mean percentage of US N. meningitidis serogroup B strains killed by each subject, at 1:4 and 1:8 dilutions before the 3-dose vaccination series, at Month 6 (PRE) and at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).Analysis was performed on FAS-Effectiveness (Months 6, 7 & 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, got subject ID & vaccination, & provided serum sample with enc-hSBA result for at least 1 endemic N. meningitidis serogroup B invasive disease strain before Month 6 & at Months 7 & 10
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End point type |
Secondary
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End point timeframe |
At Month 6 (before the 3-dose vaccination series) and at Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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No statistical analyses for this end point |
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End point title |
Percentages of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥1:8 at 1 and 4 months after the 3-dose vaccination series | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three 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 ≥ 1:8 against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) at 1 and 4 months after the 3-dose vaccination series (Month 7 and Month 10).Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
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End point type |
Secondary
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End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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No statistical analyses for this end point |
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End point title |
HT-hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs against four N. meningitidis serogroup B test strains (M14459, M07-0241084, 96217 and NZ98/254) after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Months 7 &10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
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End point type |
Secondary
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End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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No statistical analyses for this end point |
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End point title |
Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ Lower Limit of Quantitation (LLQ) at 1 month after the 3-dose vaccination series. | ||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (96217, M07-0241084,M14459 and NZ98/254), at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain. The LLQ cut off values for strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6, 8.9, 8 and 8.2 respectively.
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End point type |
Secondary
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End point timeframe |
At Month 7 (1 month after the 3-dose vaccination series)
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No statistical analyses for this end point |
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End point title |
Percentages of subjects with HT-hSBA titers against N. meningitidis serogroup B test strains ≥ LLQ at 4 months after the 3-dose vaccination series | ||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ LLQ against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup strain.The LLQ cut off values for the strains 96217, M07-0241084,M14459 and NZ98/254 were 8.6,8.9, 8 and 8.2 respectively.
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End point type |
Secondary
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End point timeframe |
At Month 10 (4 months after the 3-dose vaccination series)
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No statistical analyses for this end point |
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End point title |
Percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
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End point type |
Secondary
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End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
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||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At months 7 and 10 (1 and 4 months after 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroup B test strains, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination (month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
HT-hSBA GMTs against N. meningitidis serogroups A, C, W and Y. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY compared to a single dose of MenACWY vaccine, in terms of HT-hSBA GMTs to serogroups A, C, W, and Y, at 1 and 4 months after the 3-dose vaccination series.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subjects D & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 1 month after the 3- dose vaccination series | ||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.The LLQ cut off values for serogroups A,C,W and Y were 22.7,5.2, 39.6 and 14.7 respectively. Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 7 (1 month after the 3-dose vaccination series)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentages of subjects with HT-hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 4 months after the 3-dose vaccination series | ||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ LLQ against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.The LLQ cut off values for serogroups A, C, W and Y were 22.7,5.2,39.6 and 14.7 respectively.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided informed consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 and whose immunogenicity assay result was available for at least one serogroup B strain
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 10 (4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of subjects with two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C,W and Y at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a two-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. The two-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 2 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least two times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of subjects with three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a three-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The three-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 3 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least three times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of subjects with four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y at 1 and 4 months after the 3-dose vaccination series. | ||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with a four-fold rise in HT-hSBA titers against the N. meningitidis serogroups A, C, W and Y, at 1 and 4 months after the 3-dose vaccination series. The four-fold titers rise is defined as: a) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers < LLQ, postvaccination HT-hSBA titers ≥ 4 LLQ; b) for subjects with pre-vaccination(month 6 from the parent study) HT-hSBA titers ≥ LLQ, an increase of at least four times the pre-vaccination HT-hSBA titers.Analysis was performed on the FAS-Immunogenicity (months 7 and 10)- included all screened subjects who provided consent & demographic &/baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at months 7 & 10 & whose immunogenicity assay result was available for at least one serogroup B strain.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Months 7 and 10 (1 and 4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 1 Month After the 3-dose Vaccination Series | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup B test strain.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 7 (1 month after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentages of Subjects With HT-hSBA Titers Against N. Meningitidis Serogroup B Test Strains ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 at 4 Months After the 3-dose Vaccination Series | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of percentages of subjects with HT-hSBA titers ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroup N. meningitidis B test strains (M14459, M07-0241084, 96217 and NZ98/254), at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup B test strain.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 10 (4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 1 Month After the 3- Dose Vaccination Series | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 against serogroups A, C, W, Y, at 1 month after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 7)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 7 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 7 (1 month after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentages of Subjects With HT-hSBA Titers Against the N. Meningitidis Serogroup A, C, W and Y ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 at 4 Months After the 3-dose Vaccination Series | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The immunogenicity of three doses of MenABCWY vaccine compared to a single dose of MenACWY, in terms of the percentages of subjects with HT-hSBA titers≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against serogroups A, C, W, Y, at 4 months after the 3-dose vaccination series.Analysis was performed on FAS-Immunogenicity (Month 10)- included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & vaccination, & provided evaluable serum samples at Month 10 & whose immunogenicity assay result was available for at least one serogroup A, C, W and Y test strain.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 10 (4 months after the 3-dose vaccination series)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited local or systemic Adverse Events (AEs) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subjects reporting any solicited local or systemic AEs from Day 1 (6 hours) to Day 7 after any meningococcal vaccination is reported. Assessed solicited local symptoms were induration, erythema and pain. Assessed solicited general symptoms were fatigue, myalgia, arthralgia, headache, fever, chills and loss of appetite. Other solicited data included prevention of pain/fever and treatment of pain/fever. Any = occurrence of the symptom regardless of intensity grade.Analysis was performed on Safety Set (solicited AEs & other solicited reactions)-included all screened subjects who provided consent & demographic &/or baseline screening assessments, received a subject ID & a study vaccination, & provided post-vaccination reactogenicity data.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 1 (6 hours) to Day 7 after vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any unsolicited AEs | ||||||||||||
End point description |
The number of subjects reporting unsolicited AEs after any vaccination is reported. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.Analysis was performed on Safety set (unsolicited AEs)- included all screened subjects who provided informed consent & demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and had post-vaccination unsolicited adverse event records.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Day 1 to Day 30 after any vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs), medically-attended AEs and AEs leading to premature withdrawal. | ||||||||||||||||||
End point description |
The number of subjects reporting any SAEs, medically-attended AEs and AEs leading to premature withdrawal during the entire study period is reported. SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any unsolicited AE regardless of intensitygrade or relation to vaccination.Analysis was performed on Safety Set (overall)- included all screened subjects who provide informed consent and demographic and/or baseline screening assessments, received a subject ID and a study vaccination, and have either post-vaccination reactogenicity data or post-vaccination unsolicited adverse event records.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
During the entire study period (from Day 0 up to Month 10)
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited local and general AEs were collected from Day 1 to Day 7. Unsolicited AEs were collected from Day 1 to Day 30. SAEs, medically-attended AEs and AEs leading to withdrawal are collected for the entire duration of the study (from Day 0 to Month 10)
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Total number of subjects at risk for the frequent AEs were analysed from the exposed set & the number of subjects at risk for each of the individual adverse event were analysed from overall safety set. Therefore, the number of subjects at risk for each adverse event is lesser than total number of subjects at risk
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
21.0
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects who received 1 dose of placebo and 1 dose of MenACWY vaccine in the parent study and 1 dose of placebo in the current study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenABCWY Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects who received 2 doses of MenABCWY vaccine in the parent study and a 3rd dose of MenABCWY vaccine in the current study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - 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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed [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: The analysis was performed on the Exposed set, only on subjects with their symptom sheets completed |
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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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03 Feb 2015 |
Rationale-As per CBER feedback on HT-hSBA validation plan, CBRE agreed to replace strain M01-0240364 with 96217. The minimum required safety follow-up after last vaccination was specified.In addition, need to obtain safety information at the planned last study contact was justified. Footnote for compostion of intervention was added for consistency. |
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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 reported |