Clinical Trial Results:
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
Summary
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EudraCT number |
2019-004461-41 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
14 Sep 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Aug 2021
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First version publication date |
12 Aug 2021
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Other versions |
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 |
MET59
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04084769 | ||
WHO universal trial number (UTN) |
U1111-1217-2137 | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur Inc.
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Sponsor organisation address |
Discovery Drive, Swiftwater, PA, United States, 18370-0187
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Public contact |
Trial Transparency Team, Sanofi Pasteur Inc, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi Pasteur Inc, 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) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-001930-PIP01-16 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
23 Mar 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Sep 2020
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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 |
To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in subjects who were first vaccinated with 1 dose of MenACYW Conjugate vaccine or Menveo (meningococcal Group B) vaccine 3-6 years before the booster dose (Groups 1 and 2).
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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 |
03 Sep 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Puerto Rico: 40
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Country: Number of subjects enrolled |
United States: 530
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Worldwide total number of subjects |
570
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
546
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Adults (18-64 years) |
24
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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 |
Study subjects were enrolled from 03-September-2019 to 07-March-2020 at 30 active sites in the United States and Puerto Rico. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 570 subjects who received MenACYW Conjugate vaccine or Menveo vaccine in Study MET50 (NCT02199691) or Study MET43 (NCT02842853), or outside of Sanofi Pasteur trials were enrolled in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Blinding implementation details |
Partially-randomised design: all subjects primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while subjects primed with Menveo vaccine were automatically allocated to Group 2 (not randomised).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1: MenACYW Conjugate Vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Arm title
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Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Arm title
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Group 3: MenACYW Conjugate vaccine + Trumenba vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Investigational medicinal product name |
Meningococcal Group B vaccine (Trumenba®)
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Investigational medicinal product code |
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Other name |
Trumenba®
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Arm title
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Group 4: MenACYW Conjugate vaccine + Bexsero vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Investigational medicinal product name |
Meningococcal Group B vaccine (Bexsero®)
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Investigational medicinal product code |
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Other name |
Bexsero®
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM, single dose.
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Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data. [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: SAfAS: Subjects who had received study vaccine in MET59 and had available safety data. [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by serum bactericidal assay using human complement (hSBA) assessed at Day 06 after vaccination in Group 1 and 2. [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2. [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2. [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS1: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Group 1 and 2. [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or serum bactericidal assay using baby rabbit complement (rSBA) assessed at Day 30 after vaccination [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: PPAS2: Subjects who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination. |
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Baseline characteristics reporting groups
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Reporting group title |
Group 1: MenACYW Conjugate Vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
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Reporting group description |
Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: MenACYW Conjugate vaccine + Trumenba vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1: MenACYW Conjugate Vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||
Reporting group title |
Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
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Reporting group description |
Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | ||
Reporting group title |
Group 3: MenACYW Conjugate vaccine + Trumenba vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). | ||
Reporting group title |
Group 4: MenACYW Conjugate vaccine + Bexsero vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). | ||
Subject analysis set title |
Pooled Groups 1, 3 and 4: MenACYW Conjugate Vaccine
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Included all subjects of Groups 1, 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Subjects of Group 1 received a single IM dose of MenACYW Conjugate vaccine and Group 3 and 4 subjects received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).
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Subject analysis set title |
Pooled Groups 3 and 4: MenACYW Conjugate Vaccine
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Included all subjects of Groups 3 and 4 who received MenACYW Conjugate vaccine in previous studies MET50 or MET43. Subjects of Group 3 and 4 subjects received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine and Bexsero vaccine at Day 0 in the present study (MET59).
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End point title |
Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 [1] [2] | ||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for subjects with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. Analysis was performed on PPAS2 population that included subjects who received 1 dose of study vaccine in MET59 and had a valid post-vaccination serology result with no relevant protocol deviation; defined for evaluating the immune response of MenACYW vaccine measured by hSBA or rSBA assessed at Day 30 after vaccination.
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End point type |
Primary
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End point timeframe |
Day 30 (post-vaccination) in study MET59
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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: There was a statistical hypothesis as described in the endpoint description but could not reported due to single arm design. [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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2 [3] [4] | ||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%. Analysis was performed on PPAS2 population.
|
||||||||||||||||
End point type |
Primary
|
||||||||||||||||
End point timeframe |
Day 30 (post-vaccination) in study MET59
|
||||||||||||||||
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: There was a statistical hypothesis as described in the endpoint description but could not reported due to single arm design. [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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||
|
|||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [5] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS1 population that included subjects who received 1 dose of study vaccine in MET59 and had valid serology result with no relevant protocol deviations; defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 06 after vaccination in Groups 1 and 2.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 6 (post-vaccination) in study MET59
|
||||||||||||||||||||||||
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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [6] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on PPAS1 population.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 6 (post-vaccination) in study MET59
|
||||||||||||||||||||||||
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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [7] | ||||||||||||||||||||||||
End point description |
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS1 population.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 6 (post-vaccination) in study MET59
|
||||||||||||||||||||||||
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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [8] | ||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS2 population.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||
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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
Statistical analysis title |
Serogroup A | ||||||||||||||||||||||||
Comparison groups |
Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
|
||||||||||||||||||||||||
Number of subjects included in analysis |
350
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
other [9] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in percentage | ||||||||||||||||||||||||
Point estimate |
1.65
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-3.58 | ||||||||||||||||||||||||
upper limit |
6.95 | ||||||||||||||||||||||||
Notes [9] - 95% Confidence Interval (CI) of the difference in percentage was calculated from the Wilson Score method without continuity correction. |
|||||||||||||||||||||||||
Statistical analysis title |
Serogroup C | ||||||||||||||||||||||||
Comparison groups |
Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
|
||||||||||||||||||||||||
Number of subjects included in analysis |
350
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
other [10] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in percentage | ||||||||||||||||||||||||
Point estimate |
-1.74
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-5.5 | ||||||||||||||||||||||||
upper limit |
1.6 | ||||||||||||||||||||||||
Notes [10] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction. |
|||||||||||||||||||||||||
Statistical analysis title |
Serogroup Y | ||||||||||||||||||||||||
Comparison groups |
Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
|
||||||||||||||||||||||||
Number of subjects included in analysis |
350
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
other [11] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in percentage | ||||||||||||||||||||||||
Point estimate |
-1.15
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-4.09 | ||||||||||||||||||||||||
upper limit |
1.14 | ||||||||||||||||||||||||
Notes [11] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction. |
|||||||||||||||||||||||||
Statistical analysis title |
Serogroup W | ||||||||||||||||||||||||
Comparison groups |
Group 1: MenACYW Conjugate Vaccine v Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)
|
||||||||||||||||||||||||
Number of subjects included in analysis |
350
|
||||||||||||||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||||||||||||||
Analysis type |
other [12] | ||||||||||||||||||||||||
Method |
|||||||||||||||||||||||||
Parameter type |
Difference in percentage | ||||||||||||||||||||||||
Point estimate |
-1.16
|
||||||||||||||||||||||||
Confidence interval |
|||||||||||||||||||||||||
level |
95% | ||||||||||||||||||||||||
sides |
2-sided
|
||||||||||||||||||||||||
lower limit |
-4.72 | ||||||||||||||||||||||||
upper limit |
2.07 | ||||||||||||||||||||||||
Notes [12] - 95% CI of the difference in percentage was calculated from the Wilson Score Method without continuity correction. |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [13] | ||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer >=1:8. Analysis was performed on PPAS2 population.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||
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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2 [14] | ||||||||||||||||||||||||||||||||||||
End point description |
GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS2 population.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||
Notes [14] - 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: For this endpoint, data were not planned to be collected and analysed for Groups 3, and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 | ||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘n’=subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 | ||||||||||||||||||||||||||||||||||||||||
End point description |
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology results. Here, ‘n’ = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43 [15] | ||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43
|
||||||||||||||||||||||||||||||||||||
Notes [15] - 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: For this endpoint, data were planned to be collected and analysed for pooled population of groups 1, 3 and 4 as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59 [16] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on full analysis set which included all subjects who had a valid pre-vaccination serology result. Here, ‘number of subjects analysed’ = subjects evaluable for this endpoint and ‘n’ = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||||||||||
Notes [16] - 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: For this endpoint, data were planned to be collected and analysed for pooled population of groups 1, 3 and 4, as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [17] | ||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for subjects with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for subjects with pre-vaccination hSBA titer >= 1:8. Analysis was performed on PPAS2 population. Here, ‘n’ = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||
Notes [17] - 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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4 only, as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Percentage of Subjects With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [18] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8. Analysis was performed on PPAS2 population. Here, ‘n’ = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [18] - 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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4, as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4 [19] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution. Analysis was performed on PPAS2 population. Here, 'n' = subjects with available data for each specified category.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [19] - 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: For this endpoint, data were planned to be collected and analysed for individual Groups 1, 3 and 4 and for pooled population of groups 3 and 4, as pre-specified in the protocol. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination) in MET59. Solicited reactions (SR): within 7 days post-vaccination in MET59. Serious AEs data: up to 30 days days post-vaccination in MET59.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Analysis performed on SafAS population.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
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Reporting groups
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Reporting group title |
Group 1: MenACYW Conjugate Vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2: MenACYW Conjugate Vaccine (Menveo Vaccine-primed)
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Reporting group description |
Subjects who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 3: MenACYW Conjugate Vaccine + Trumenba Vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 4: MenACYW Conjugate Vaccine + Bexsero Vaccine
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Reporting group description |
Subjects who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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22 Jan 2020 |
Following changes were made: •Visit 3 was changed to Visit 2 for the main cohort (all subjects excluding the subset) following updates to the table of study procedures. •Visit 3 was replaced by Day 30 since this naming convention applies for all study subjects (main cohort and subset cohort).•FAS1 (full analysis set for Day 06) and FAS2 (full analysis set for Day 30) populations were defined (2 FAS analysis sets instead of 1). •Additional details were included to the statistical analysis: Geometric Mean Titer Ratio (GMTR) was added.
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10 Apr 2020 |
Following changes were made: •Were completed to comply with changes requested by Center for Biologics Evaluation and Research (CBER)/Food and Drug Administration (FDA): - the primary objective and endpoint, and related statistical analyses, -one secondary objective; -observational objectives; calculation of sample size.
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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 |