Meningococcal infection MedDRA version: 20.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 12 to 23 months on the day of inclusion - Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator - Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 study (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 - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine - Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature = 38.0°C [= 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided - Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID- 19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. - Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine -Receipt of immunoglobulins, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the immune response to a booster dose of MenQuadfi® as measured by the serum bactericidal assay using human complement (hSBA) in toddlers aged 12-23 months, who had been primed with at least 1 dose of another MCV4 vaccine during infancy • To describe the safety profile of a booster dose of MenQuadfi® administered to toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy • To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 1 month after a booster dose of MenQuadfi® as measured by hSBA in toddlers 12-23 months of age who had been primed with at least 1 dose, 1 dose or 2 doses of another MCV4 vaccine during infancy • To describe the antibody responses to tetanus toxoid before and 1 month after a booster dose of MenQuadfi® in toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy;Secondary Objective: • To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 1 month after a booster dose of MenQuadfi® as measured by rSBA in toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy;Primary end point(s): 1. hSBA antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W 2. Number of participants with immediate adverse events (AEs) 3. Number of participants with solicited injection site reactions or systemic reactions 4. Number of participants with unsolicited AEs 5. Number of participants with serious adverse events (SAEs) 6. hSBA antibody titers against meningococcal serogroups A, C, Y, and W 7. hSBA antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W 8. Percentage of Participants who achieved =4-fold rise in antibody titers over baseline measured by hSBA 9. hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse 10. Anti-tetanus antibody concentra | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W 2. rSBA antibody titers = several pre-defined thresholds against meningococcal serogroups A, C, Y, and W 3. Percentage of Participants who achieved =4-fold rise in antibody titers over baseline measured by rSBA 4. rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse;Timepoint(s) of evaluation of this end point: D01 and D31 (+14 days) after booster vaccination | — |
Countries
Argentina
Contacts
Public ContactGlobal Regulatory Affairs
Sanofi Pasteur
Outcome results
None listed