Clinical Trial Results:
A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 years in Korea.
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
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Summary
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EudraCT number |
2014-005083-15 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
05 Apr 2014
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Results information
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Results version number |
v2(current) |
This version publication date |
04 Jun 2016
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First version publication date |
03 May 2015
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Other versions |
v1 (removed from public view) |
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 |
V72_42
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01973218 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics
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Sponsor organisation address |
Via Fiorentina 1, Siena, Italy, 53100
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Public contact |
Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines and Diagnostics S.r.l., RegistryContactVaccinesUS@novartis.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
18 Mar 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Apr 2014
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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 |
Immunogenicity:
To assess the immunogenicity following two doses (Day 1 and Day 31) of Novartis rMenB+OMV NZ vaccine and control vaccines in healthy adolescents, as measured by the percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 against indicator strains H44/76, 5/99 and NZ98/254 one month after the second dose (Day 61).
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Protection of trial subjects |
This clinical study was designed, implemented and reported in accordance with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guidelines for Good Clinical Practice (GCP), with applicable local regulations, Novartis Vaccines and Diagnostics codes on protection of human rights, and with the ethical principles laid down in the Declaration of Helsinki (European Council 2001, US Code of Federal Regulations, ICH 1997).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Apr 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 |
Korea, Republic of: 264
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Worldwide total number of subjects |
264
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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) |
42
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Adolescents (12-17 years) |
222
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited from 7 study centers in Korea. | ||||||||||||||||||
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Pre-assignment
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Screening details |
All enrolled subjects were included in the trial. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall 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, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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rMenB | ||||||||||||||||||
Arm description |
Subjects received two doses of Meningococcal B Recombinant + Outer Membrane Vesicles New Zealand vaccine (rMenB+OMV NZ) vaccine (at Day 1 and Day 31) in the study. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
rMenB+ OMV NZ
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5mL of rMenB+OMV NZ vaccine on Day 1 and Day 31.
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Arm title
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Placebo/MenACWY | ||||||||||||||||||
Arm description |
Subjects received one dose of saline placebo (Day 1) and one dose of Meningococcal (groups A, C, W, and Y) Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine (MenACWY-CRM) (Day 31) in the study. | ||||||||||||||||||
Arm type |
Placebo/ Active comparator | ||||||||||||||||||
Investigational medicinal product name |
MenACWY
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received 0.5mL of MenACWY vaccine on Day 31 after receiving saline solution on Day 1.
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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 |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects received saline at Day 1.
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Baseline characteristics reporting groups
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Reporting group title |
rMenB
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Reporting group description |
Subjects received two doses of Meningococcal B Recombinant + Outer Membrane Vesicles New Zealand vaccine (rMenB+OMV NZ) vaccine (at Day 1 and Day 31) in the study. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of saline placebo (Day 1) and one dose of Meningococcal (groups A, C, W, and Y) Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine (MenACWY-CRM) (Day 31) in the study. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
rMenB
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Reporting group description |
Subjects received two doses of Meningococcal B Recombinant + Outer Membrane Vesicles New Zealand vaccine (rMenB+OMV NZ) vaccine (at Day 1 and Day 31) in the study. | ||
Reporting group title |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of saline placebo (Day 1) and one dose of Meningococcal (groups A, C, W, and Y) Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine (MenACWY-CRM) (Day 31) in the study. | ||
Subject analysis set title |
All Enrolled Set
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects who have signed the informed consent, undergone screening procedures and were randomized.
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Subject analysis set title |
Safety Set (overall)
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects in the Exposed Set who have either post-vaccination adverse event or “reactogenicity” records. Subjects will be analyzed as "treated" (i.e., according to the vaccine a subject received, rather than the vaccine to which the subject may have been randomized).
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Subject analysis set title |
Full Analysis Set (FAS)
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects in the Enrolled Population who received at least one dose of study vaccination and provide immunogenicity data at relevant time points.
FAS populations will be analyzed “as randomized” (i.e., subject is analyzed according to the vaccine he/she was designated to receive, which may be different from the vaccine the subject actually received).
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End point title |
1. Percentage of subjects with human serum bactericidal antibody titers (SBA) ≥1:4 against Neisseria meningitidis serogroup B by vaccine group. [1] | ||||||||||||||||||||||||||||||
End point description |
Percentage of subjects with SBA ≥1:4 against each of the three indicators strains of N.meningitidis serogroup B, at one month after second vaccination, were reported for each group.
Analysis was done on the Full Analysis Set i.e. all subjects who received at least one study vaccine and had immunogenicity data at relevant timepoints.
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End point type |
Primary
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End point timeframe |
Day 1, Day 61
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis is associated to this Endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
2. The SBA Geometric Mean Titers (GMTs) against N.meningitidis serogroup B, by vaccine group. | ||||||||||||||||||||||||||||||
End point description |
The SBA antibody titers against each of the three indicator strains of N.meningitidis serogroup B at one month after second vaccination were reported as GMTs, for each group.
Analysis was done on the Full Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 1, Day 61
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
3. The geometric mean ratio (GMRs) of post- versus pre-vaccination SBA titers Against N.meningitidis serogroup B, by vaccine group. | |||||||||||||||||||||
End point description |
The GMRs of post-vaccination versus pre-vaccination SBA titers against each of the three indicator strains of N.meningitidis serogroup B, at one month after second vaccination (Day 61/Day 1) are reported, for each group.
Analysis was done on the Full Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 61/ Day 1
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
4. The percentages of subjects with a four-fold increase in SBA antibody titers against N.meningitidis serogroup B, by vaccine group. | |||||||||||||||||||||
End point description |
Percentages of subjects with a four-fold increase in SBA antibody titers from baseline against each of the three indicator strains of N.meningitidis serogroup B, at one month after second vaccination are reported, for each group.
Analysis was done on the Full Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 61
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
5. The Geometric mean concentrations (GMCs) against vaccine antigen 287-953, by vaccine group. | ||||||||||||||||||
End point description |
The GMCs against vaccine antigen 287-953, at one month after second vaccination are reported, for each group.
Analysis was done on the Full Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 1, Day 61
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
6. The GMR of post versus pre-vaccination GMCs against vaccine antigen 287-953, by vaccine group. | |||||||||||||||
End point description |
The GMR of post-vaccination versus pre-vaccination GMCs against vaccine antigen 287-953, at one month after the second vaccination (Day 61/Day 1) are reported, for each group.
Analysis was done on the Full Analysis Set.
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End point type |
Secondary
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End point timeframe |
Day 61/Day 1
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
7. The number of subjects reporting solicited adverse events (AEs) after each study vaccination, by vaccine group. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
The number of subjects reporting solicited local and systemic AEs following vaccination rMenB+OMV NZ or placebo/MenACWY-CRM, are reported.
Analysis was done on the safety set for solicited AEs i.e all subjects who received the at least one study vaccination and had solicited AE data.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 7 after each vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
8. The number of subjects reporting unsolicited AEs after any vaccination, by vaccine group. | ||||||||||||||||||||||||||||||
End point description |
The number of subjects reporting any unsolicited AEs, serious adverse events (SAEs), AEs leading to premature withdrawal and medically attended AEs (throughout the study), following vaccination rMenB+OMV NZ or placebo/MenACWY-CRM,were reported.
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End point type |
Secondary
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End point timeframe |
Day 1 to Day 61
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Throughout the study
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Adverse event reporting additional description |
Solicited AEs were collected between Day 1 to Day 7 after each vaccination; any unsolicited AEs (including serious AEs, medically attended AEs and AEs leading to premature withdrawal) from Day 1 to Day 61 (throughout the study).
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Placebo/MenACWY
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Reporting group description |
Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
rMenB
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Reporting group description |
Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None | |||
