Clinical Trial Results:
Persistence of antibodies after vaccination with a dose of GSK Biologicals’ meningococcal vaccine GSK134612 in healthy children and safety and immunogenicity of a booster dose at 68 months post-primary vaccination.
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Summary
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EudraCT number |
2010-018730-51 |
Trial protocol |
FR DE |
Global end of trial date |
17 May 2014
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Results information
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Results version number |
v1 |
This version publication date |
01 Apr 2016
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First version publication date |
24 May 2015
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Other versions |
v2 , v3 |
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 |
113977
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01266993 | ||
WHO universal trial number (UTN) |
- | ||
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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) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Interim
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Date of interim/final analysis |
07 Jul 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
17 May 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Immunogenicity
Persistence
At 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate.
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBAMenA,
rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines 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. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jan 2011
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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 |
68 Months | ||
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 |
France: 97
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Country: Number of subjects enrolled |
Germany: 185
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Worldwide total number of subjects |
282
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EEA total number of subjects |
282
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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) |
282
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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 |
- | |||||||||
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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. | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
282 | |||||||||
Number of subjects completed |
271 | |||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
No vaccination received: 11 | |||||||||
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Period 1
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Period 1 title |
Month 32
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Month 32 Group | |||||||||
Arm description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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Arm title
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Menjugate Month 32 Group | |||||||||
Arm description |
Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix (GSK134612 vaccine) in the current study. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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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: The difference in subjects is further detailed in the pre-assignment period. |
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Period 2
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Period 2 title |
Month 44
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Month 44 Group | |||||||||
Arm description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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Arm title
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Menjugate Month 44 Group | |||||||||
Arm description |
Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix (GSK134612 vaccine) in the current study | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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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 subjects completing a study period returned for the next one. |
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Period 3
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Period 3 title |
Month 56
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Is this the baseline period? |
No | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nimenrix Month 56 Group | |||||||||
Arm description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study and a booster dose of the same vaccine in the current study. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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Arm title
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Menjugate Month 56 Group | |||||||||
Arm description |
Subjects who received Menjugate® in the primary study and a booster dose of Nimenrix (GSK134612 vaccine) in the current study | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Nimerix®
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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 |
Intramuscular administration in the non-dominant deltoid/thigh region at Day 0, 1 dose.
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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 subjects completing a study period returned for the next one. |
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Baseline characteristics reporting groups
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Reporting group title |
Nimenrix Month 32 Group
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Reporting group description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Menjugate Month 32 Group
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Reporting group description |
Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix (GSK134612 vaccine) in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nimenrix Month 32 Group
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Reporting group description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study. | ||
Reporting group title |
Menjugate Month 32 Group
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Reporting group description |
Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix (GSK134612 vaccine) in the current study. | ||
Reporting group title |
Nimenrix Month 44 Group
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Reporting group description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study received a booster dose of the same vaccine in the current study. | ||
Reporting group title |
Menjugate Month 44 Group
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Reporting group description |
Subjects who received Menjugate® in the primary study received a booster dose of Nimenrix (GSK134612 vaccine) in the current study | ||
Reporting group title |
Nimenrix Month 56 Group
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Reporting group description |
Subjects who received Nimenrix (GSK134612 vaccine) in the primary study and a booster dose of the same vaccine in the current study. | ||
Reporting group title |
Menjugate Month 56 Group
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Reporting group description |
Subjects who received Menjugate® in the primary study and a booster dose of Nimenrix (GSK134612 vaccine) in the current study | ||
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End point title |
Number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY antibody titres ≥1:8 [1] | |||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Primary
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End point timeframe |
At month 32 after primary vaccination
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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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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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, rSBA-MenY antibody titres ≥1:8 [2] | |||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Primary
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End point timeframe |
At month 44 after primary vaccination
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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 scope of this primary endpoint was descriptive, no statistical analyses were conducted. |
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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, rSBA-MenY antibody titres ≥1:8 | |||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 32 months after the primary vaccination
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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, rSBA-MenY antibody titres ≥1:8 | |||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 44 months after the primary vaccination
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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, rSBA-MenY antibody titres ≥1:128 | |||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Secondary
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End point timeframe |
At 32 months after the primary vaccination
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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, rSBA-MenY antibody titres ≥1:128 | |||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Secondary
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End point timeframe |
At 44 months after the primary vaccination
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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, rSBA-MenY antibody titres ≥1:128 | |||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 32 months after the primary vaccination
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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, rSBA-MenY antibody titres ≥1:128 | |||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 44 months after the primary vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY | ||||||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Secondary
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End point timeframe |
At 32 months after the primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY | ||||||||||||||||||||||||
End point description |
These analyses were performed by the Health Protection Agency (HPA) laboratory
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End point type |
Secondary
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End point timeframe |
At 44 months after the primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY | ||||||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 32 months after the primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY | ||||||||||||||||||||||||
End point description |
These analyses were performed by the GSK laboratory
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End point type |
Secondary
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End point timeframe |
At 44 months after the primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 32 after primary vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 44 after primary vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 32 after primary vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:8 | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 44 after primary vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 32 after primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Antibody titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY | ||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 44 after primary vaccination
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of subjects with any SAEs | |||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Up to Month 32, 44 and 56
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| No statistical analyses for this end point | ||||||||||||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Subjects with solicited local and general symptoms during the 4-day period (Days 0-3) following the booster vaccination. Unsolicited adverse events, serious adverse events and specific during the 31-day period (Days 0-30) following the booster vaccinaton.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Nimenrix Group until month 32
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Reporting group description |
- | |||||||||||||||||||||||||
Reporting group title |
Menjugate Group until month 32
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Reporting group description |
- | |||||||||||||||||||||||||
Reporting group title |
Nimenrix Group until month 44
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Reporting group description |
- | |||||||||||||||||||||||||
Reporting group title |
Menjugate Group until month 44
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Reporting group description |
- | |||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were collected up to the present timepoint in the study. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Aug 2010 |
This amendment has been done to answer the requests of the French and German ethics committees to not use Menjugate as a booster vaccination since Menjugate has no booster indication in France and also to not use Menveo as a booster vaccination since Menveo is currently not licensed for the age group in this study and has no booster indication. |
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15 Dec 2011 |
The primary objective of the study was to evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rabbit serum bactericidal assay (rSBA)-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8 at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate.
In addition, to support the data obtained by rSBA testing, antibody titres and concentrations against meningococcal polysaccharides were planned to be assessed by human (h)SBA testing and ELISA (anti-polysaccharides [PS] testing) at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate and at Month 69, one month after the MenACWY-TT booster vaccination. The sponsor decided not to perform the ELISA testing at all time points 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 polysaccharides [CDC, 2011; WHO, 2006].
Although antibody concentrations will not be determined by ELISA at 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate and at Month 69, one month after the MenACWY-TT booster vaccination, all subjects will be informed of their rSBA and hSBA antibody titres at each immunogenicity time point when statistical analyses at that time point have been completed.
In addition:
• The protocol amendment clarifies in which laboratory the different assays will be performed.
• The introduction has been updated with the current licensing status of competitor meningococcal vaccines.
• The list of abbreviations and reference list have been updated according to changes made throughout the protocol.
The authors list has been updated according to changes in the clinical study team.
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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 | |||
