Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
- Conditions
- Meningococcal ImmunisationHealthy Volunteers
- Interventions
- Biological: Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
- Registration Number
- NCT04936685
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief 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.
- Detailed Description
The duration of each participant's participation will be approximately 5.5 years
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 209
- Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
- Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
- Covered by health insurance, if required by local regulations
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
- At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
- Personal history of Guillain-Barré syndrome (GBS)
- Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
- Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine 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 Group 2 Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073
- Primary Outcome Measures
Name Time Method Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year 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%.
- Secondary Outcome Measures
Name Time Method Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose 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.
Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) Within 30 minutes after vaccination 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).
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 At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51) 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).
Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 Baseline (Day 1) and Day 31 after the administration of a 5-year 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 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.
Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128 Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose 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.
Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose 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.
Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination Baseline (Day 1) and Day 31 after the administration of a 5-year 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 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.
Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose 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.
Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions 7 days after vaccination 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.
Group 1: Number of Participants With Unsolicited AEs Within 30 days after vaccination 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.
Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8 From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration From Baseline (Day 1) until end of the study (approximately 5.5 years) 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.
Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI) From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks 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.
Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose 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.
Trial Locations
- Locations (26)
Investigational Site Number : 2760002
🇩🇪Mönchengladbach, Germany
Investigational Site Number : 2460002
🇫🇮Järvenpää, Finland
Investigational Site Number : 2460010
🇫🇮Turku, Finland
Investigational Site Number : 2460009
🇫🇮Espoo, Finland
Investigational Site Number : 2460001
🇫🇮Helsinki, Finland
Investigational Site Number : 2460006
🇫🇮Helsinki, Finland
Investigational Site Number : 2460004
🇫🇮Kokkola, Finland
Investigational Site Number : 2460007
🇫🇮Oulu, Finland
Investigational Site Number : 2460003
🇫🇮Pori, Finland
Investigational Site Number : 2460008
🇫🇮Tampere, Finland
Investigational Site Number : 2760001
🇩🇪Bramsche, Germany
Investigational Site Number : 2760007
🇩🇪Bretten, Germany
Investigational Site Number : 2760011
🇩🇪Bönnigheim, Germany
Investigational Site Number : 2760006
🇩🇪Schönau, Germany
Investigational Site Number : 2760015
🇩🇪Hamburg, Germany
Investigational Site Number : 2760004
🇩🇪Erfurt, Germany
Investigational Site Number : 2760008
🇩🇪Mönchengladbach, Germany
Investigational Site Number : 2760003
🇩🇪Tauberbischofsheim, Germany
Investigational Site Number : 3480001
🇭🇺Budapest, Hungary
Investigational Site Number : 3480005
🇭🇺Miskolc, Hungary
Investigational Site Number : 3480002
🇭🇺Budapest, Hungary
Investigational Site Number : 7240001
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 3480006
🇭🇺Székesfehérvár, Hungary
Investigational Site Number : 7240006
🇪🇸Santiago de Compostela, Galicia [Galicia], Spain
Investigational Site Number : 7240003
🇪🇸Sevilla, Spain
Investigational Site Number : 7240002
🇪🇸Madrid, Spain