Clinical Trial Results:
A Phase 3b, Open-Label, Randomized, Multicenter Study to Assess the Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal group B Vaccine When Administered Concomitantly with GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants
Summary
|
|
EudraCT number |
2016-005117-44 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
14 Oct 2016
|
Results information
|
|
Results version number |
v1 |
This version publication date |
22 Oct 2017
|
First version publication date |
22 Oct 2017
|
Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
205240
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT02106390 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
11 Aug 2017
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
14 Oct 2016
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
14 Oct 2016
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
The purpose of this trial was to assess the immunological non-inferiority of rMenB+OMV NZ and MenACWY when concomitantly administered compared to either alone in healthy infants at 3, 5, 7 and 13 months of age, as measured by the ratio of hSBA Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains (for rMenB+OMV NZ) and serogroups A, C, W-135 and Y (for MenACWY) at one month after the fourth vaccination.
|
||
Protection of trial subjects |
The subjects were observed closely for at least 30 minutes following the administration of vaccine(s), with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Jun 2014
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Argentina: 163
|
||
Country: Number of subjects enrolled |
Mexico: 587
|
||
Worldwide total number of subjects |
750
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
750
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment details |
750 healthy infants, aged 3 months were recruited from 3 sites in Argentina and 4 sites in Mexico. | ||||||||||||||||||||||||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||
Screening details |
All enrolled subjects were included in the study. | ||||||||||||||||||||||||||||||||||||||||
Period 1
|
|||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||
Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
This trial is designed as an open-label trial; therefore, no blinding procedures were used.
|
||||||||||||||||||||||||||||||||||||||||
Arms
|
|||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
rMenB+ACWY Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GlaxoSmithKline Biologicals Meningococcal group B Vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
rMenB+OMV NZ; Bexsero
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
1 mL pre-filled syringe. The volume delivered in a single dose was 0.5 mL.
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GlaxoSmithKline Biologicals Meningococcal ACWY Conjugate Vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
MenACWY; Menveo
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Powder and solution for solution for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Powder (vial) + Solution (syringe or vial). The volume delivered after reconstitution was 0.5 mL.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
rMenB Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GlaxoSmithKline Biologicals Meningococcal group B Vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
rMenB+OMV NZ; Bexsero
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
1 mL pre-filled syringe. The volume delivered in a single dose was 0.5 mL.
|
||||||||||||||||||||||||||||||||||||||||
Arm title
|
MenACWY Group | ||||||||||||||||||||||||||||||||||||||||
Arm description |
Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
GlaxoSmithKline Biologicals Meningococcal ACWY Conjugate Vaccine
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||||||||||||||||||||||||
Other name |
MenACWY; Menveo
|
||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Powder and solution for solution for injection
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Powder (vial) + Solution (syringe or vial). The volume delivered after reconstitution was 0.5 mL.
|
||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
rMenB+ACWY Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
rMenB Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
rMenB+ACWY Group
|
||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | ||
Reporting group title |
rMenB Group
|
||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age. | ||
Reporting group title |
MenACWY Group
|
||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. |
|
|||||||||||||||||||||||||
End point title |
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) against each of the serogroup B indicator strains [1] | ||||||||||||||||||||||||
End point description |
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 after receiving 4 doses of rMenB+OMV NZ/MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. The analysis was done on the Per Protocol Set (PPS).
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [1] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the H44/76 serogroup B indicator strain, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
rMenB+ACWY Group v rMenB Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
306
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [2] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
0.89
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.71 | ||||||||||||||||||||||||
upper limit |
1.1 | ||||||||||||||||||||||||
Notes [2] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the 5/99 serogroup B indicator strain, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
rMenB+ACWY Group v rMenB Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
306
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [3] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.03
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.74 | ||||||||||||||||||||||||
upper limit |
1.45 | ||||||||||||||||||||||||
Notes [3] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the NZ98/254 serogroup B indicator strain, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
rMenB+ACWY Group v rMenB Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
306
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [4] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.01
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.82 | ||||||||||||||||||||||||
upper limit |
1.25 | ||||||||||||||||||||||||
Notes [4] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ) was performed for the M10713 serogroup B indicator strain, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
rMenB+ACWY Group v rMenB Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
306
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [5] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.03
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.77 | ||||||||||||||||||||||||
upper limit |
1.4 | ||||||||||||||||||||||||
Notes [5] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus rMenB+OMV NZ is > 0.5 for all serogroup B indicator strains. |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroups A, C, W-135 and Y [6] | ||||||||||||||||||||||||
End point description |
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ/MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. The analysis was done on the PPS.
|
||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [6] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 1 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus MenACWY) was performed for serogroup A, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
MenACWY Group v rMenB+ACWY Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
317
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [7] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
2.48
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
1.97 | ||||||||||||||||||||||||
upper limit |
3.11 | ||||||||||||||||||||||||
Notes [7] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 2 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus MenACWY) was performed for serogroup C, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
MenACWY Group v rMenB+ACWY Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
317
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [8] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.07
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.83 | ||||||||||||||||||||||||
upper limit |
1.38 | ||||||||||||||||||||||||
Notes [8] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 3 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus MenACWY) was performed for serogroup W-135, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
MenACWY Group v rMenB+ACWY Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
317
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [9] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.34
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
1.04 | ||||||||||||||||||||||||
upper limit |
1.74 | ||||||||||||||||||||||||
Notes [9] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y. |
|||||||||||||||||||||||||
Statistical analysis title |
Statistical analysis 4 | ||||||||||||||||||||||||
Statistical analysis description |
The comparison of adjusted GMTs ratio (rMenB+OMV NZ + MenACWY versus MenACWY) was performed for serogroup Y, at one month after the fourth vaccination.
|
||||||||||||||||||||||||
Comparison groups |
MenACWY Group v rMenB+ACWY Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
317
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [10] | ||||||||||||||||||||||||
Method |
ANOVA | ||||||||||||||||||||||||
Parameter type |
GMT ratio | ||||||||||||||||||||||||
Point estimate |
1.05
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
0.82 | ||||||||||||||||||||||||
upper limit |
1.35 | ||||||||||||||||||||||||
Notes [10] - Non-inferiority was to be concluded if, at one month following the fourth vaccination, the lower limits of the two-sided 95% confidence interval for the between-group ratios of GMTs (rMenB+OMV NZ + MenACWY versus MenACWY) was > 0.5 for all serogroups A, C, W-135 and Y. |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroup B indicator strains [11] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at baseline (Day 1). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. Analysis was performed on the Full Analysis Set (FAS).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [11] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroup B indicator strains [12] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at one month after the third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [12] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroup B indicator strains [13] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [13] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroup B indicator strains [14] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [14] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroups A, C, W-135 and Y [15] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the serogroups A, C, W-135 and Y were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [15] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroups A, C, W-135 and Y [16] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the serogroups A, C, W-135 and Y were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [16] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroups A, C, W-135 and Y [17] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the serogroups A, C, W-135 and Y were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [17] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA Geometric Mean Titers against each of the serogroups A, C, W-135 and Y [18] | ||||||||||||||||||||||||
End point description |
hSBA GMTs against each of the N.meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the serogroups A, C, W-135 and Y were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [18] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:5 against each of the serogroup B indicator strains [19] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 before the first vaccination (Day 1). This outcome measure applies only rMenB+ACWY and rMenB groups as the serogroup B strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [19] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:5 against each of the serogroup B indicator strains [20] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 one month after the third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [20] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:5 against each of the serogroup B strains [21] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [21] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:5 against each of the serogroup B strains [22] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:5 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 one month after the fourth vaccination (Day 331). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [22] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroup B indicator strains [23] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at baseline (Day 1). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [23] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroup B indicator strains [24] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at one month after third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [24] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroup B indicator strains [25] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [25] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroup B indicator strains [26] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at one month after the fourth vaccination (Day 331). This outcome measure applies only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [26] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:4 against each of the serogroups A, C, W-135 and Y [27] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the first vaccination (Day 1). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [27] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:4 against each of the serogroups A, C, W-135 and Y [28] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [28] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:4 against each of the serogroups A, C, W-135 and Y [29] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [29] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:4 against each of the serogroups A, C, W-135 and Y [30] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:4 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [30] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Within-subject Geometric Mean Ratios (GMRs) against each of the serogroup B indicator strains [31] | ||||||||||||||||||||||||
End point description |
GMRs of GMTs against each of the serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 were calculated at one month after the fourth vaccination (Day 331) versus prior to the fourth vaccination (Day 301). Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331/Day 301
|
||||||||||||||||||||||||
Notes [31] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Within-subject GMRs against each of serogroups A, C, W-135 and Y [32] | ||||||||||||||||||||||||
End point description |
GMRs of GMTs against each of serogroups A, C, W-135 and Y were calculated at one month after the fourth vaccination (Day 331) versus prior to the fourth vaccination (Day 301). Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331/Day 301
|
||||||||||||||||||||||||
Notes [32] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with four-fold increases in hSBA titers against each of the serogroup B indicator strains [33] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with four-fold increases in hSBA titers against each of the N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713 at one month after the fourth vaccination (Day 331) over prior to the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [33] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with four-fold increases in hSBA titers against each of the serogroups A, C, W-135 and Y [34] | ||||||||||||||||||||||||
End point description |
Percentages of subjects with four-fold increases in hSBA titers against each of the N. meningitidis serogroups A,C,W-135 and Y at one month after the fourth vaccination (Day 331) over prior to the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [34] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroups A, C, W-135 and Y [35] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at baseline (Day 1). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 1
|
||||||||||||||||||||||||
Notes [35] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroups A, C, W-135 and Y [36] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the third vaccination (Day 151). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 151
|
||||||||||||||||||||||||
Notes [36] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroups A, C, W-135 and Y [37] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y before the fourth vaccination (Day 301). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 301
|
||||||||||||||||||||||||
Notes [37] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of subjects with hSBA titers ≥1:8 against each of the serogroups A, C, W-135 and Y [38] | ||||||||||||||||||||||||
End point description |
Percentage of subjects with hSBA titers ≥ 1:8 against each of the N. meningitidis serogroups A, C, W-135 and Y at one month after the fourth vaccination (Day 331). This outcome measure applies only to rMenB+ACWY and MenACWY groups as the A, C, W-135 and Y serogroups were assessed only for these two groups. Analysis was performed on the FAS.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Day 331
|
||||||||||||||||||||||||
Notes [38] - 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: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local and systemic Adverse Events (AEs) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after each vaccination. Analysis was performed on the solicited Safety Set.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
From Day 1 (6 hours) to Day 7 after each vaccination (Days 1, 61, 121 and 301)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||
End point title |
Number of subjects with unsolicited adverse events | ||||||||||||||||||||||||||||||||
End point description |
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject who was administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Analysis was performed on the unsolicited Safety Set.
|
||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||
End point timeframe |
From Day 1 to Day 7 after each vaccination (Days 1, 61, 121 and 301)
|
||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with SAEs, AEs leading to withdrawal and medically attended AEs (MAEs) | ||||||||||||||||||||||||
End point description |
A serious adverse event is any untoward medical occurrence that at any dose results in death, is life threatening, requires prolonged hospitalization or results in persistent or significant disability, incapacity, congenital anomaly or birth defect. MAEs include 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. Analysis was performed on the unsolicited Safety Set.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Throughout the whole study period (from Day 1 up to Day 331)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited local and systemic symptoms: from Day 1 (6 hours) up to Day 7 after each vaccination; Unsolicited AEs: from Day 1 up to Day 7; SAEs: throughout the whole study period (from Day 1 to Day 331).
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.0
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
rMenB+ACWY Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ / MenACWY vaccines, concomitantly administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACWY Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of MenACWY administered at 3, 5, 7 and 13 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
rMenB Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Approximately 250 healthy infants aged 3 months who received 4 doses of rMenB + OMV NZ administered at 3, 5, 7 and 13 months of age | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |