Clinical trial NCT04936685: 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
Official title: A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine With 5- and/or 10-year Booster Doses in Children and Adolescents Who Had Been Primed With MenACYW Conjugate Vaccine as Toddlers.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Meningococcal Immunisation
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-06-23
Enrollment: 209
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Group 1: Percentage of Participants With Sufficiency of Serum Bactericidal Assay Using Human Complement (hSBA) Vaccine Seroresponse at 30 Days Post Booster Dose
timeFrame: Baseline (Day 1) and 30 days after the MenACYW conjugate vaccine 5-year booster dose
Secondary outcomes:
measure: 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
timeFrame: At Day 1 (approximately 5 year after the administration of a priming dose as toddlers in study MET51)
measure: Group 1: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Percentage of Participants With hSBA Titer >= 1:4 and >= 1:8
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Percentage of Participants With rSBA Titer >= 1:8 and >= 1:128
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Percentage of Participants With hSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Percentage of Participants With rSBA Titer >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Percentage of Participants With >=0.01 International Units (IU)/mL and >=0.1 IU/mL Anti-Tetanus Antibody Concentration
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
timeFrame: Baseline (Day 1) and Day 31 after the administration of a 5-year booster dose
measure: Group 2: Geometric Mean Concentrations of Anti-Tetanus Antibody Concentration
timeFrame: From Baseline (Day 1) until end of the study (approximately 5.5 years)
measure: Group 1: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
timeFrame: Within 30 minutes after vaccination
measure: Group 1: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
timeFrame: 7 days after vaccination
measure: Group 1: Number of Participants With Unsolicited AEs
timeFrame: Within 30 days after vaccination
measure: Group 1: Number of Participants With Serious AEs (SAEs) and Adverse Event of Special Interest (AESI)
timeFrame: From the first study vaccine administration up to primary completion date of 09 March 2023, approximately 28 weeks
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Investigational Site Number : 2460009
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460001
city: Helsinki
country: Finland
facility: Investigational Site Number : 2460006
city: Järvenpää
country: Finland
facility: Investigational Site Number : 2460002
city: Kokkola
country: Finland
facility: Investigational Site Number : 2460004
city: Oulu
country: Finland
facility: Investigational Site Number : 2460007
city: Pori
country: Finland
facility: Investigational Site Number : 2460003
city: Tampere
country: Finland
facility: Investigational Site Number : 2460008
city: Turku
country: Finland
facility: Investigational Site Number : 2460010
city: Bramsche
country: Germany
facility: Investigational Site Number : 2760001
city: Bretten
country: Germany
facility: Investigational Site Number : 2760007
city: Bönnigheim
country: Germany
facility: Investigational Site Number : 2760011
city: Erfurt
country: Germany
facility: Investigational Site Number : 2760004
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760015
city: Mönchengladbach
country: Germany
facility: Investigational Site Number : 2760002
city: Mönchengladbach
country: Germany
facility: Investigational Site Number : 2760008
city: Schönau
country: Germany
facility: Investigational Site Number : 2760006
city: Tauberbischofsheim
country: Germany
facility: Investigational Site Number : 2760003
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480001
city: Miskolc
country: Hungary
facility: Investigational Site Number : 3480005
city: Székesfehérvár
country: Hungary
facility: Investigational Site Number : 3480006
city: Santiago de Compostela
country: Spain
facility: Investigational Site Number : 7240006
state: Galicia [Galicia]
city: Madrid
country: Spain
facility: Investigational Site Number : 7240001
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: