Clinical Trial Results:
A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine with 5-and/or 10-year Booster Doses in Children and Adolescents who had been Primed with MenACYW Conjugate Vaccine as Toddlers
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Summary
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EudraCT number |
2021-000104-38 |
Trial protocol |
FI HU DE ES |
Global end of trial date |
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Mar 2024
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First version publication date |
08 Mar 2024
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Other versions |
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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 |
MEQ00073
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04936685 | ||
WHO universal trial number (UTN) |
U1111-1255-4941 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Pasteur Inc.
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Sponsor organisation address |
Discovery Drive, Swiftwater, Pennsylvania, United States, 18370-0187
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Public contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Interim
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Date of interim/final analysis |
08 Nov 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Mar 2023
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Global end of trial reached? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of MenACYW conjugate vaccine in subjects who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier as toddlers.
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Protection of trial subjects |
Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Aug 2022
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety | ||
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: 41
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Country: Number of subjects enrolled |
Germany: 58
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Country: Number of subjects enrolled |
Hungary: 59
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Country: Number of subjects enrolled |
Spain: 51
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Worldwide total number of subjects |
209
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EEA total number of subjects |
209
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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) |
209
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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 |
The study was conducted at 26 centres in 4 countries from 23 August 2022 to 06 February 2023. | |||||||||||||||
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Pre-assignment
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Screening details |
A total of 209 subjects were enrolled in this study. Results has been reported as per the primary completion date of 09 March 2023. Final analysis results will be reported at later date. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Not applicable
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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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MenACYW: Group 1 | |||||||||||||||
Arm description |
Subjects received a first intramuscular (IM) booster dose of 0.5 millilitre (mL) of Meningococcal polysaccharide (Serogroups A, C, Y and W) (MenACYW conjugate vaccine) at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51) and will receive a second booster dose at Year 5 of the study (visit 3, at adolescent age approximately 5 years post booster dose as children in this study). | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
MenACYW conjugate vaccine
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Investigational medicinal product code |
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Other name |
MenQuadfi®
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were administered MenACYW conjugate vaccine through IM injection in the deltoid muscle of arm at Day 1 and at Year 5 of the study.
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Arm title
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MenACYW: Group 2 | |||||||||||||||
Arm description |
Subjects will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51). | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
MenACYW conjugate vaccine
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Investigational medicinal product code |
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Other name |
MenQuadfi®
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects will be administered MenACYW conjugate vaccine through IM injection in the deltoid muscle of arm at Year 5 of the study.
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Baseline characteristics reporting groups
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Reporting group title |
MenACYW: Group 1
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Reporting group description |
Subjects received a first intramuscular (IM) booster dose of 0.5 millilitre (mL) of Meningococcal polysaccharide (Serogroups A, C, Y and W) (MenACYW conjugate vaccine) at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51) and will receive a second booster dose at Year 5 of the study (visit 3, at adolescent age approximately 5 years post booster dose as children in this study). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
MenACYW: Group 2
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Reporting group description |
Subjects will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
MenACYW: Group 1
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Reporting group description |
Subjects received a first intramuscular (IM) booster dose of 0.5 millilitre (mL) of Meningococcal polysaccharide (Serogroups A, C, Y and W) (MenACYW conjugate vaccine) at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51) and will receive a second booster dose at Year 5 of the study (visit 3, at adolescent age approximately 5 years post booster dose as children in this study). | ||
Reporting group title |
MenACYW: Group 2
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Reporting group description |
Subjects will receive a single IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Year 5 (visit 2) of the study (approximately 10 years post priming dose as toddlers in study MET51). | ||
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End point title |
Group 1: Percentage of Subjects With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose [1] [2] | ||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y was defined as: percentage of subjects with a pre-vaccination titer < 1:8, who had achieved a post-vaccination titer >= 1:16 or subjects with a pre-vaccination titer >= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is > 75%. The Per-Protocol Analysis Sets 1 (PPAS1) was a subset of the Full analysis set (FAS). The FAS consisted of subjects who had received the study vaccine and had a valid post-vaccination serology result 5-years after priming vaccination at visit 1. Here, n= number of subjects whose titers met the hSBA vaccine seroresponse criteria are analysed and 9999= Only 1-sided CI was determined.
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End point type |
Primary
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End point timeframe |
Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose. Assessed until primary analysis date.
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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: As the endpoint is descriptive in nature, no statistical analysis is provided. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Subjects Achieving Titer (Seroprotection) >=1:8 hSBA and Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Titer >=1:8 Approximately 5 Years After the Primary Vaccination | ||||||||||||||||||||||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as vaccine seroprotection. Seroprotection rate is defined as percentage of subjects with hSBA titer and rSBA titer >=1.8 who received MenACYW conjugate vaccine 5 years earlier. Antibody persistence of meningococcal serogroups A, C, W, and Y in children at 5 years (Groups 1 and 2). The FAS3 consisted of subjects who had a valid baseline serology results (hSBA or rSBA accordingly). Only data from the subjects analysed were reported. Here, n= number of subjects analysed for each specific serogroup.
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End point type |
Secondary
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End point timeframe |
Day 1 (Visit 1) up to 5 year after the administration of a priming dose as toddlers in study MET51.
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y [3] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the rSBA and the results were expressed as geometric mean titers. The PPAS is a subset of the FAS and hSBA and rSBA PPAS1 individually consisted of subjects for Group 1 visit 1. Only data from the subjects analysed were reported. Here, n= number of subjects analysed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With hSBA Titer >= 1:4 and >= 1:8 [4] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for subjects with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for subjects with pre-vaccination hSBA titer >= 1:8. The PPAS is a subset of the FAS and hSBA PPAS1 consisted of subjects for Group 1.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With rSBA Titer >= 1:8 and >= 1:128 [5] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for subjects with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for subjects with pre-vaccination rSBA titer >= 1:8. The PPAS is a subset of the FAS and rSBA PPAS1 consisted of subjects for Group 1. Only data from the subjects analysed were reported. Here, n= number of subjects analysed at specific time point.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Subjects With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination [6] | ||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:16 for subjects with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for subjects with pre-vaccination hSBA titer >= 1:8. The PPAS is a subset of the FAS and hSBA PPAS1 consisted of subjects for Group 1.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination [7] | ||||||||||||||||
End point description |
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse is defined as a post-vaccination titer >= 1:32 for subjects with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for subjects with pre-vaccination rSBA titer >= 1:8. The PPAS is a subset of the FAS and rSBA PPAS1 consisted of subjects for Group 1. Only data from the subjects analysed were reported. Here, n= number of subjects analysed for each specific serogroup.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Percentage of Subjects With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration [8] | ||||||||||||||||
End point description |
Anti-tetanus antibodies were measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent (DTP-ECL) assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous hemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate. The PPAS is a subset of the FAS and hSBA PPAS1 consisted of subjects for Group 1.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration [9] | ||||||||||||
End point description |
Anti-tetanus antibodies were measured by DTP-ECL assay, a multiplexed serological assay that allowed for the simultaneous quantification of human antibodies to 6 specific antigens including diphtheria toxoid, tetanus toxoid, and 4 pertussis antigens: pertussis toxin, filamentous haemagglutinin, fimbriae and pertactin. The captured antibodies were then detected using a sulfotag-conjugated anti-human Ig G conjugate. The PPAS is a subset of the FAS and hSBA PPAS1 consisted of subjects for Group 1.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose. Assessed until primary analysis date.
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| Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Immediate Unsolicited Systemic Adverse Events (AEs) [10] | ||||||
End point description |
An AE is any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e, pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination). The Safety analysis set 1 (SafAS 1) consisted of subjects who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
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End point type |
Secondary
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End point timeframe |
Within 30 minutes after vaccination. Assessed until primary analysis date.
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| Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Subjects With Solicited Injection Site Reactions and Systemic Reactions [11] | ||||||||||
End point description |
All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an “expected” AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection/administration site reaction is an AR at and around the injection/administration site. Injection/administration site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localised or topical manifestations that are not associated with the vaccination or administration site. The SafAS 1 consisted of subjects who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
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End point type |
Secondary
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End point timeframe |
7 days after vaccination. Assessed until primary analysis date.
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| Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With Unsolicited AEs [12] | ||||||
End point description |
An AE is any untoward medical occurrence in a subject or clinical study subject, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination). Unsolicited AEs included both serious and non-serious unsolicited AEs. The SafAS 1 consisted of subjects who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
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End point type |
Secondary
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End point timeframe |
Within 30 days after vaccination. Assessed until primary analysis date.
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| Notes [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||
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End point title |
Number of Subjects With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) [13] | ||||||||||
End point description |
A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event. An AESI (serious or non-serious) is defined as one of scientific and medical concern specific to the Sponsor’s study vaccination or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. The SafAS 1 consisted of subjects who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1).
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End point type |
Secondary
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End point timeframe |
From the first study vaccine administration to the last study vaccine administration (approximately 5.5 years). Assessed until primary analysis date.
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| Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only subjects in reporting group "MenACYW: Group 1" were analysed at the time of primary analysis date. |
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| No statistical analyses for this end point | |||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
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Adverse event reporting additional description |
Analysis was performed on SafAS1 population.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
MenACYW Group 1
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Reporting group description |
Subjects received a first IM booster dose of 0.5 mL of MenACYW conjugate vaccine at Day 1 (visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Feb 2022 |
Amended to add a study arm in order to describe the immunogenicity and safety of a booster dose and the persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 10 years earlier as toddlers as part of the MET51 study. It was also to increase the study duration in the initial study arm to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose. |
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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 | |||
