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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1255-4941 | Registry Identifier | ICTRP | |
| 2021-000104-38 | EudraCT Number |
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The purpose of the MEQ00073 study is to assess the immunogenicity and safety of a booster dose in children who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as toddlers as part of the MET51 study, and to describe the persistence of a priming dose in children and adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years or 10 years earlier as toddlers as part of the MET51 study, the immunogenicity and safety of a booster dose in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study, and the immunogenicity and safety of a second booster dose in adolescents approximately 5 years after a first booster dose as children approximately 5 years after the priming dose as toddlers.
The duration of each participant's participation will be approximately 5.5 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive a first booster dose of MenACYW conjugate vaccine at Day 1 and a second booster dose at year 5 of study MEQ00073 |
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| Group 2 | Experimental | Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine | Biological | Liquid solution for injection Intramuscular |
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| Measure | Description | Time Frame |
|---|---|---|
| Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | 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 is defined as: percentage of participants with a pre-vaccination titer < 1:8, who had achieved a post-vaccination titer >= 1:16 or participants 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%. | Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants 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 | 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 participants 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 2460009 | Espoo | 02230 | Finland | |||
| Investigational Site Number : 2460001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40169489 | Derived | Martinon-Torres F, Simko R, Ebert R, Ramet M, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) and Immunogenicity and Safety of a Booster Dose in Children. Infect Dis Ther. 2025 May;14(5):991-1010. doi: 10.1007/s40121-025-01121-6. Epub 2025 Apr 1. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 209 participants 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 a later date.
The study was conducted at 26 centers in 4 countries from 23 August 2022 to 06 February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACYW: Group 1 | Participants received a first intramuscular (IM) booster dose of 0.5 milliliter (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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 16, 2022 | Mar 22, 2024 |
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| At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51) |
| Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | 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. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | 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. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | 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. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | 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. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | 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. | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
| Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | 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. | From Baseline (Day 1) until end of the study (approximately 5.5 years) |
| Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical study participant, 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). | Within 30 minutes after vaccination |
| Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | 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 localized or topical manifestations that are not associated with the vaccination or administration site. | 7 days after vaccination |
| Group 1: Number of Participants With Unsolicited AEs | An AE is any untoward medical occurrence in a participant or clinical study participant, 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. | Within 30 days after vaccination |
| Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) | A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, 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. | From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks |
| Helsinki |
| 00100 |
| Finland |
| Investigational Site Number : 2460006 | Helsinki | 00930 | Finland |
| Investigational Site Number : 2460002 | Jarvenpaa | 04400 | Finland |
| Investigational Site Number : 2460004 | Kokkola | 67100 | Finland |
| Investigational Site Number : 2460007 | Oulu | 90220 | Finland |
| Investigational Site Number : 2460003 | Pori | 28100 | Finland |
| Investigational Site Number : 2460008 | Tampere | 33100 | Finland |
| Investigational Site Number : 2460010 | Turku | 20520 | Finland |
| Investigational Site Number : 2760011 | Bönnigheim | 74357 | Germany |
| Investigational Site Number : 2760001 | Bramsche | 49565 | Germany |
| Investigational Site Number : 2760007 | Bretten | 75015 | Germany |
| Investigational Site Number : 2760004 | Erfurt | 99086 | Germany |
| Investigational Site Number : 2760015 | Hamburg | 22415 | Germany |
| Investigational Site Number : 2760002 | Mönchengladbach | 41236 | Germany |
| Investigational Site Number : 2760008 | Mönchengladbach | 41236 | Germany |
| Investigational Site Number : 2760006 | Schönau | 83471 | Germany |
| Investigational Site Number : 2760003 | Tauberbischofsheim | 97941 | Germany |
| Investigational Site Number : 3480002 | Budapest | 1042 | Hungary |
| Investigational Site Number : 3480001 | Budapest | 1188 | Hungary |
| Investigational Site Number : 3480005 | Miskolc | 3527 | Hungary |
| Investigational Site Number : 3480006 | Székesfehérvár | 8000 | Hungary |
| Investigational Site Number : 7240006 | Santiago de Compostela | Galicia [Galicia] | 15706 | Spain |
| Investigational Site Number : 7240001 | Madrid | Madrid, Comunidad de | 28046 | Spain |
| Investigational Site Number : 7240002 | Madrid | 28007 | Spain |
| Investigational Site Number : 7240003 | Seville | 41014 | Spain |
| FG001 | MenACYW: Group 2 | Participants 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). |
| COMPLETED |
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| NOT COMPLETED |
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Participants with data in Case report form (CRF) consisted of all study participants with CRF, i.e with data in the clinical database.
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACYW: Group 1 | Participants had a blood sample before receiving 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). |
| BG001 | MenACYW: Group 2 | Participants had a blood sample at Day 1 (Visit 1, at child age approximately 5 years post priming dose as toddlers in study MET51). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | year |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
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| Primary | Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose | 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 is defined as: percentage of participants with a pre-vaccination titer < 1:8, who had achieved a post-vaccination titer >= 1:16 or participants 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) is a subset of the Full analysis set (FAS). The FAS consisted of participants who had received the study vaccine and had a valid post-vaccination serology result 5-years after priming vaccination at visit 1. Participants data whose titers meet the hSBA vaccine seroresponse criteria have been reported. | Posted | Number | 97.5% Confidence Interval | percentage of participants | Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose |
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| Secondary | Antibody Persistence of Meningococcal (Groups 1 and 2): Percentage of Participants 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 | 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 participants 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 participants who had a valid baseline serology results (hSBA or rSBA accordingly). Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51) |
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| Secondary | Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | 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 participants for Group 1 visit 1. Only data from the participants analyzed were reported. | Posted | Geometric Mean | 95% Confidence Interval | titer | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y | 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. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | The PPAS is a subset of the FAS and hSBA PPAS1 consisted of participants for Group 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination hSBA titer >= 1:8. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | The PPAS is a subset of the FAS and rSBA PPAS1 consisted of participants for Group 1. Only data from the participants analyzed were reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination | 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 participants with pre-vaccination rSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase at post baseline for participants with pre-vaccination rSBA titer >= 1:8. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | 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 participants for Group 1. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration | 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. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | 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 participants for Group 1. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose |
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| Secondary | Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration | 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. | Not Posted | Dec 2028 | From Baseline (Day 1) until end of the study (approximately 5.5 years) | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant or clinical study participant, 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 participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1). | Posted | Count of Participants | Participants | No | Within 30 minutes after vaccination |
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| Secondary | Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | 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 localized or topical manifestations that are not associated with the vaccination or administration site. | The SafAS 1 consisted of participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1). | Posted | Count of Participants | Participants | No | 7 days after vaccination |
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| Secondary | Group 1: Number of Participants With Unsolicited AEs | An AE is any untoward medical occurrence in a participant or clinical study participant, 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 participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1). | Posted | Count of Participants | Participants | No | Within 30 days after vaccination |
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| Secondary | Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) | A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, 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 participants who had received the study vaccine 5 years after priming vaccination (Visit 1) and had any safety data available (Group 1). | Posted | Count of Participants | Participants | No | From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks |
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From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks.
Analysis was performed on SafAS1 population. For 'MenACYW: Group 2', no safety data will be collected as no vaccine administration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MenACYW: Group 1 | Participants 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). | 0 | 93 | 3 | 93 | 72 | 93 |
| EG001 | MenACYW: Group 2 | Participants 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). | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
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| Giardiasis | Infections and infestations | MedDra 26.0 | Systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | MedDra 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Erythema | General disorders | MedDra 26.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDra 26.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDra 26.0 | Systematic Assessment |
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| Malaise | General disorders | MedDra 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDra 26.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 26.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDra 26.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2023 | Mar 22, 2024 | SAP_003.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Serogroup W |
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| Serogroup Y |
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