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
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine: Liquid solution for injection Intramuscular
Study summary
The purpose of the MEQ00073 study is to describe the immunogenicity and safety of a booster dose and persistence of a priming dose of MenACYW conjugate vaccine (MenQuadfi®) in adolescents who had been vaccinated approximately 10 years earlier as toddlers as part of the MET51 study and to describe the immunogenicity and safety of a second booster dose (as adolescents approximately 5 years after the first booster dose) and the persistence of a first booster dose of MenACYW in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study and had received a first booster dose as children approximately 5 years after the priming dose.
Eligibility
Sex
ALL
Min age
6 Years
Max age
7 Years
Healthy volunteers
Accepted
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 outcome measure(s)
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%.
Trial sites (27)
Facility
City
Region
Status
Investigational Site Number : 2460009
Espoo
Finland
Investigational Site Number : 2460001
Helsinki
Finland
Investigational Site Number : 2460006
Helsinki
Finland
Investigational Site Number : 2460002
Jarvenpaa
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 : 2460010
Turku
Finland
Investigational Site Number : 2760011
Bönnigheim
Germany
Investigational Site Number : 2760001
Bramsche
Germany
Investigational Site Number : 2760007
Bretten
Germany
Investigational Site Number : 2760004
Erfurt
Germany
Investigational Site Number : 2760009
Goch
Germany
Investigational Site Number : 2760015
Hamburg
Germany
Investigational Site Number : 2760002
Mönchengladbach
Germany
Investigational Site Number : 2760008
Mönchengladbach
Germany
Investigational Site Number : 2760006
Schönau am Königssee
Germany
Investigational Site Number : 2760003
Tauberbischofsheim
Germany
Investigational Site Number : 3480002
Budapest
Hungary
Investigational Site Number : 3480001
Budapest
Hungary
Investigational Site Number : 3480005
Miskolc
Hungary
Investigational Site Number : 3480006
Székesfehérvár
Hungary
Investigational Site Number : 7240006
Santiago de Compostela
Galicia [Galicia]
Investigational Site Number : 7240001
Madrid
Madrid, Comunidad de
Investigational Site Number : 7240002
Madrid
Spain
Investigational Site Number : 7240003
Seville
Spain
More Sanofi Pasteur, a Sanofi Company trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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