Clinical Trial Results:
A phase III, open, multi-centre, controlled study to evaluate the long-term antibody persistence at 2 years, 3 years and 4 years after a single dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroup A, C, W-135, Y- tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of Meningitec™ administered in healthy 12 through 23-month old children who were primed in study MenACWY-TT-039 (109670) and to evaluate the immunogenicity and safety of a booster dose of the same meningococcal conjugate vaccine as given in the primary study, 4 years after priming.
Summary
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EudraCT number |
2008-003824-51 |
Trial protocol |
FI |
Global end of trial date |
10 Sep 2012
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Results information
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Results version number |
v2 |
This version publication date |
12 Aug 2016
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First version publication date |
13 Jun 2015
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Other versions |
v1 , 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 |
112036
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00955682 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000429-PIP01-08 | ||
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 |
Interim
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Date of interim/final analysis |
31 May 2013
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Dec 2009
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Sep 2012
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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
Persistence
At 24, 36, and 48 months after primary vaccination of toddlers with MenACWY-TT or Meningitec
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres ≥ 1:8 for each of the four serogroups.
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Protection of trial subjects |
All subjects were supervised for 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Aug 2009
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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 |
Finland: 342
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Worldwide total number of subjects |
342
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EEA total number of subjects |
342
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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) |
342
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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) |
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 |
- | |||||||||||||||
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. | |||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
342 | |||||||||||||||
Number of subjects completed |
295 | |||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Not fulfilling protocol criteria: 47 | |||||||||||||||
Period 1
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Period 1 title |
Year 2 Period
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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 Y2 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Arm title
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Meningitec Group Y2 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. 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 2
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Period 2 title |
Year 3 Period
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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 Y3 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Arm title
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Meningitec Group Y3 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Period 3
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Period 3 title |
Year 4 Period
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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 Y4 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Arm title
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Meningitec Group Y4 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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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 |
Booster Period (Month 49)
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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 Booster (Month 49) | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm, vaccination administered in the 109670 study. Subjects are boosted with one dose of Nimenrix™ four years after the primary vaccination.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study.
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Arm title
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Meningitec Group Booster (Month 49) | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm. Vaccination administered in the 109670 study.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm. Vaccination administered in the 109670 study. Subjects are boosted with one dose of Priorix-Tetra™ four years after the primary vaccination.
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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 5 Period
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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 Y5 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Nimenrix™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant arm.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm.
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Arm title
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Meningitec Group Y5 | |||||||||||||||
Arm description |
- | |||||||||||||||
Arm type |
Active comparator | |||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
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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 intramuscular injection in the deltoid of non-dominant arm.
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Investigational medicinal product name |
Priorix-Tetra™
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 doses administered subcutaneously into the deltoid region of the dominant 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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Baseline characteristics reporting groups
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Reporting group title |
Nimenrix Group Y2
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Meningitec Group Y2
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nimenrix Group Y2
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Reporting group description |
- | ||
Reporting group title |
Meningitec Group Y2
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group Y3
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Reporting group description |
- | ||
Reporting group title |
Meningitec Group Y3
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group Y4
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Reporting group description |
- | ||
Reporting group title |
Meningitec Group Y4
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group Booster (Month 49)
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Reporting group description |
- | ||
Reporting group title |
Meningitec Group Booster (Month 49)
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Reporting group description |
- | ||
Reporting group title |
Nimenrix Group Y5
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Reporting group description |
- | ||
Reporting group title |
Meningitec Group Y5
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Reporting group description |
- |
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End point title |
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using baby rabbit complement) titres ≥ 1:8. [1] | |||||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At Month 24 post Nimenrix™ vaccine.
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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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8. [2] | |||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the rSBA were presents at Month 24 timepoints tested at the GSK laboratory, while the other endpoints presents only the Year 3 timepoint tested at the HPA laboratory.
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End point type |
Primary
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End point timeframe |
At Month 36 post Nimenrix™ vaccine.
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Notes [2] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8. [3] | |||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3 and Year 4, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different time-points, the rSBA were presented at Month 24 time-points tested at the GSK laboratory for the Month 48 cohort, while the other endpoints presents only the Year 3 and Year 4 time-points tested at the HPA laboratory.
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
At Month 48 post Nimenrix™ vaccine.
|
|||||||||||||||||||||
Notes [3] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8. [4] | |||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
At Month 36 post-primary vaccination.
|
|||||||||||||||||||||
Notes [4] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8. [5] | |||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||
End point type |
Primary
|
|||||||||||||||||||||
End point timeframe |
At Month 48 post-primary vaccination and pre-booster vaccination.
|
|||||||||||||||||||||
Notes [5] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
||||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. | |||||||||||||||||||||
End point description |
||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At Month 24 post primary dose.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. | |||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the rSBA were presented at Month 24 timepoints tested at the GSK laboratory, while the other endpoints presents only the Year 3 timepoint tested at the HPA laboratory.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. | |||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3 and Year 4, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the rSBA were presented at Month 24 timepoints tested at the GSK laboratory for the Month 48 cohort, while the other endpoints presents only the Year 3 and Year4 timepoint tested at the HPA laboratory.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Months 24 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the rSBA were presented at Month 24 timepoints tested at the GSK laboratory, while the other endpoints presents only the Year 3 timepoint tested at the HPA laboratory.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
Note: The rSBA have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3 and Year 4, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the rSBA were presented at Month 24 timepoints tested at the GSK laboratory for the Month 48 cohort, while the other endpoints presents only the Year 3 and Year4 timepoint tested at the HPA laboratory.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. | |||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At Month 36 post-primary vaccination.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128. | |||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
At Month 48 post-primary vaccination and pre-booster vaccination.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 36 post-primary vaccination.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 48 post-primary vaccination and pre-booster vaccination.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ 1:4 and 1:8. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 24 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ 1:4 and 1:8. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with serum bactericidal assay/activity against Neisseria meningitidis serogroup A, C, W-135 and Y (using human complement) titres ≥ 1:4 and 1:8. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 24 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 24 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Note: The anti-PS have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the anti-PS were presented at Month 24 timepoints tested at the GSK laboratory, while the other endpoints presents only the Year 3 timepoint tested at the HPA laboratory.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Note: The anti-PS have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3 and Year 4, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the anti-PS were presented at Month 24 timepoints tested at the GSK laboratory for the Month 48 cohort, while the other endpoints presents only the Year 3 and Year4 timepoint tested at the HPA laboratory.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 24 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Note: The anti-PS have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the anti-PS were presented at Month 24 timepoints tested at the GSK laboratory, while the other endpoints presents only the Year 3 timepoint tested at the HPA laboratory.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 36 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Note: The anti-PS have been analysed at a different laboratory (Health Protection Agency or HPA) at Year 3 and Year 4, compared to previous years (GSK). To reflect this difference, which limits direct longitudinal comparison of the results of different timepoints, the anti-PS were presented at Month 24 timepoints tested at the GSK laboratory for the Month 48 cohort, while the other endpoints presents only the Year 3 and Year4 timepoint tested at the HPA laboratory.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 48 post primary dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 36 post-primary vaccination.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At Month 48 post-primary vaccination and pre-booster vaccination.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 36 post-primary vaccination.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-polysaccharide A (anti-PSA), anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At Month 48 post-primary vaccination and pre-booster vaccination.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres above the cut-off values. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 60 pre-primary vaccination and post-primary vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
At Month 60 pre-primary vaccination and post-primary vaccination
|
||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
rSBA-MenA results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres. | ||||||||||||||||||||||||
End point description |
|||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with anti-PSA, anti-PSC, anti-PSW, and anti-PSY above the cut-off values. | |||||||||||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Anti-PSA, anti-PSC, anti-PSW, and anti-PSY antibody concentrations. | ||||||||||||||||||||||||
End point description |
Anti-PS results for the Year 3 and Year 4 time points obtained by re-testing the samples in parallel at Public Health England (PHE).
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Number of subjects reporting any solicited local symptoms. | ||||||||||||||||||
End point description |
|||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
During the 8-day period (Days 0-7) after booster vaccination.
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of subjects reporting any solicited general symptoms. | |||||||||||||||||||||
End point description |
||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
During the 8-day period (Days 0-7) after the booster vaccination.
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any adverse events (AEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
During the 31-day period (Days 0-30) after booster vaccination.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 24 post primary dose and pre-booster vaccination.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 36
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 48
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At one month (Month 49) post booster dose.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects reporting any serious adverse events (SAEs). | ||||||||||||
End point description |
|||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At 12 months (Month 60) post booster dose.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Solicited local and general symptoms: during the 8-day period (Days 0-7) after booster vaccination. Unsolicited symptoms: during the 31-day period (Days 0-30) after booster vaccination. SAEs: during the 31-day period (Days 0-30) following vaccination.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The occurrence of reported AEs (all/related) was not available and it is encoded as equal to the number of subjects affected.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Meningitec Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nimenrix 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 |
||
07 Apr 2010 |
• At the time of writing of protocol MenACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) it was decided to test a subset of 75% of the enrolled subjects at each time point for hSBA. This was in accordance with what was initially decided for hSBA testing in the primary study MenACWY-TT-039 (109670). However, later on, it was decided to perform hSBA testing on the blood samples taken 42 days after Visit 1 in study MenACWY-TT-039 (109670) of the subjects vaccinated with MenACWY-TT (alone or co-administered with Priorix-Tetra) or Meningitec at Visit 1. Protocol MenACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) is amended to have the same subset of subjects tested for hSBA in this follow-up study. |
||
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 |