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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04936685
Other study ID # MEQ00073
Secondary ID U1111-1255-49412
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date August 23, 2022
Est. completion date December 26, 2027

Study information

Verified date April 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The duration of each participant's participation will be approximately 5.5 years


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Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
Liquid solution for injection Intramuscular

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Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

Finland,  Germany,  Hungary,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
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%. Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
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). At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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. Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
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. From Baseline (Day 1) until end of the study (approximately 5.5 years)
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). Within 30 minutes after vaccination
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. 7 days after vaccination
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. Within 30 days after vaccination
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. From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks
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