Clinical Trial Results:
A phase IIb, open, randomised, controlled primary vaccination study to evaluate the non-inferiority and the persistence of the immune response of GSK Biologicals’ meningococcal serogroup ACWY conjugate vaccine given intramuscularly versus Mencevax ACWY given subcutaneously to healthy subjects aged 11 to 55 years of age
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
Summary
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EudraCT number |
2012-002722-75 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
16 Feb 2013
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Results information
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Results version number |
v2 |
This version publication date |
12 Jun 2016
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First version publication date |
18 Jul 2015
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Other versions |
v1 (removed from public view) , v3 |
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 |
107386
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01934140 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
107392: eTrack number, 107398: eTrack number, 107402: eTrack number, 107404: eTrack number, 107406: eTrack number | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
16 Feb 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Feb 2013
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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 |
One month after vaccination:
• To evaluate the non-inferiority of the vaccine response induced by the MenACWY TT conjugate vaccine when compared to the licensed Mencevax ACWY.
• To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptom within 4 days after vaccination.
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Protection of trial subjects |
Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Dec 2006
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
5 Years | ||
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 |
Philippines: 400
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Country: Number of subjects enrolled |
Saudi Arabia: 100
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Worldwide total number of subjects |
500
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
500
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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 |
- | |||||||||||||||
Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | |||||||||||||||
Period 1
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Period 1 title |
Active Phase
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
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Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Period 2
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Period 2 title |
Year 1
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
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Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects. |
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Period 3
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Period 3 title |
Year 2
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
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Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Notes [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects. |
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Period 4
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Period 4 title |
Year 3
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
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Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Notes [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects. |
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Period 5
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Period 5 title |
Year 4
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
||||||||||||||||
Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
||||||||||||||||
Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Notes [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects. |
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Period 6
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Period 6 title |
Year 5
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Is this the baseline period? |
No | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
One dose administered intramuscularly in the non-dominant deltoid region.
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Arm title
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Mencevax Group | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Mencevax™
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Investigational medicinal product code |
||||||||||||||||
Other name |
GSK Biologicals’ meningococcal serogroups A, C, W-135, Y plain polysaccharide vaccine
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
One dose administered subcutaneously into the non-dominant upper arm.
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Notes [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: Not all study participants returned in time for every study visit, but they were allowed to continue the study nonetheless. The number of participants who started each study period depends on the actual rate of return of the subjects. |
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Baseline characteristics reporting groups
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Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group
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Reporting group description |
- | ||
Reporting group title |
Mencevax Group
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Reporting group description |
- |
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End point title |
Vaccine response for rSBA antibodies | ||||||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
One Month after vaccination
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Statistical analysis title |
Difference in % for rSBA-MenA antibodies | ||||||||||||||||||||||||
Statistical analysis description |
To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
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Comparison groups |
Nimenrix Group v Mencevax Group
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Number of subjects included in analysis |
442
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||||||||||||||
Method |
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Parameter type |
Difference in % for rSBA-MenA antibodies | ||||||||||||||||||||||||
Point estimate |
13
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Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
3.52 | ||||||||||||||||||||||||
upper limit |
23.5 | ||||||||||||||||||||||||
Notes [1] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was > -15%. |
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Statistical analysis title |
Difference in % for rSBA-MenC antibodies | ||||||||||||||||||||||||
Statistical analysis description |
To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
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Comparison groups |
Nimenrix Group v Mencevax Group
|
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Number of subjects included in analysis |
442
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in % for rSBA-MenC antibodies | ||||||||||||||||||||||||
Point estimate |
4.18
|
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Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-1.03 | ||||||||||||||||||||||||
upper limit |
11.36 | ||||||||||||||||||||||||
Notes [2] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%. |
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Statistical analysis title |
Difference in % for rSBA-MenW antibodies | ||||||||||||||||||||||||
Statistical analysis description |
To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
|
||||||||||||||||||||||||
Comparison groups |
Nimenrix Group v Mencevax Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
442
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [3] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in % for rSBA-MenW-135 antibo | ||||||||||||||||||||||||
Point estimate |
4.58
|
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Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-0.07 | ||||||||||||||||||||||||
upper limit |
11.49 | ||||||||||||||||||||||||
Notes [3] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%. |
|||||||||||||||||||||||||
Statistical analysis title |
Difference in % for rSBA-MenY antibodies | ||||||||||||||||||||||||
Statistical analysis description |
To evaluate the non-inferiority of the vaccine response* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.
|
||||||||||||||||||||||||
Comparison groups |
Nimenrix Group v Mencevax Group
|
||||||||||||||||||||||||
Number of subjects included in analysis |
442
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
non-inferiority [4] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in % for rSBA-MenY antibodies | ||||||||||||||||||||||||
Point estimate |
8.05
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
1.72 | ||||||||||||||||||||||||
upper limit |
16.17 | ||||||||||||||||||||||||
Notes [4] - Criterion indicative of non-inferiority: Lower limit of the standardized asymptotic 95% confidence interval (CI) for the difference between MenACWY-TT and (minus) MenACWY in the percentage of subjects with bactericidal vaccine response was ≥ -12%. |
|
|||||||||||||||||||
End point title |
Number of subjects with Grade 3 symptoms | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
Statistical analysis title |
Difference in % Grade 3 general symptoms | ||||||||||||||||||
Statistical analysis description |
To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.
|
||||||||||||||||||
Comparison groups |
Nimenrix Group v Mencevax Group
|
||||||||||||||||||
Number of subjects included in analysis |
500
|
||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||
Analysis type |
non-inferiority [5] | ||||||||||||||||||
Method |
|||||||||||||||||||
Parameter type |
Difference in % Grade 3 general symptoms | ||||||||||||||||||
Point estimate |
1.34
|
||||||||||||||||||
Confidence interval |
|||||||||||||||||||
level |
95% | ||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||
lower limit |
-1.64 | ||||||||||||||||||
upper limit |
3.09 | ||||||||||||||||||
Notes [5] - Criterion indicative of non-inferiority: Upper limit of the standardized asymptotic 95% CI on the difference between MenACWY- TT and (minus) MenACWY in the incidence of Grade 3 systemic symptoms was below 5%. |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody titres ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Concentration of rSBA antibody titres | ||||||||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PS antibody concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Concentration of anti-PS antibodies | ||||||||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects with anti-TT antibody concentrations ≥ 0.1 IU/mL | |||||||||||||||
End point description |
||||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Concentration of anti-TT antibodies | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Prior to and 1 Month after vaccination
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody concentrations ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 1
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA antibody titres | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 1
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody concentrations ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 2
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA antibody titres | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 2
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody concentrations ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 3
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA antibody titres | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 3
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody concentrations ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 4
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA antibody titres | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 4
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA antibody concentrations ≥ 1:8 and ≥ 1:128 | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 5
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA antibody titres | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 5
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PS antibody concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 1
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Concentration of anti-PS antibodies | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 1
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PS antibody concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 2
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Concentration of anti-PS antibodies | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 2
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PS antibody concentrations ≥ 0.3 µg/mL and ≥ 2.0 µg/mL | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Year 3
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Concentration of anti-PS antibodies | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 3
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms | |||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Relationship analysis was not performed.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited general symptoms | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)], gastrointestinal and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
During the 4-day (Days 0-3) post-vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with New Onset of Chronic Illnesses (NOCIs) | ||||||||||||
End point description |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 0 up to 6 Months after vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with rash | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 0 up to 6 Months after vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with AEs resulting in emergency rooms visits | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 0 up to 6 Months after vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with unsolicited AEs | ||||||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 31 Days after vaccination
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From Day 0 up to 6 months
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Number of subjects with SAEs | ||||||||||||||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Year 1, Year 2, Year 3, Year 4, Year 5
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Occurrence of solicited local and general symptoms during the 4-day (Days 0-3) post vaccination period;
Occurrence of unsolicited AE(s) up to 31 days after vaccination;
Occurrence of SAE(s) from Day 0 up to 6 months after vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Mencevax Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on the Total Vaccinated cohort, only on subjects with their symptom sheets completed. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
19 Dec 2011 |
Amendment 1
To support the data obtained by serum bactericidal assay (SBA) testing, antibody concentrations against meningococcal polysaccharides (PSs) were planned to be assessed by enzyme-linked immunosorbent assay (ELISA). The ELISA testing was performed prior to and one month after vaccination, and one, two and three years after vaccine administration, but the sponsor decided not to perform the ELISA testing at four and five years after vaccine administration for the following reasons:
• the World Health Organisation (WHO) considers SBA the primary means of assessing immune response to meningococcal conjugate vaccines [WHO, 2006; WHO,1999].
• circulating bactericidal antibodies are more critical for persistent protection against meningococcal disease than non-functional antibodies against meningococcal PSs [Centers for Disease Control (CDC), 2011; WHO, 2006].
|
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |