Phase
Condition
Healthy Volunteers
Meningococcal Infection
Treatment
MenACYW conjugate vaccine
Clinical Study ID
Ages 12-23 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 12 to 23 months on the day of inclusion
Participants who are healthy as determined by medical evaluation including medicalhistory, physical examination, and judgement of the Investigator
Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine duringinfancy before 12 months of age with an interval of at least 2 months between thelast vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose
Exclusion
Exclusion Criteria:
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 3months)
History of meningococcal infection, confirmed either clinically, serologically, ormicrobiologically
At high risk for meningococcal infection during the study (specifically but notlimited to participants with persistent complement deficiency, with anatomic orfunctional asplenia, or participants traveling to countries with high endemic orepidemic disease)
Personal history of Guillain-Barré syndrome
Personal history of an Arthus-like reaction after vaccination with a tetanus toxoidcontaining vaccine
Known systemic hypersensitivity to any of the study intervention components, orhistory of a life-threatening reaction to the study intervention used in the studyor to a product containing any of the same substances
Moderate or severe acute illness/infection (according to investigator judgment) orfebrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study interventionadministration. Prospective participant should not be included in the study untilthe condition has resolved or the febrile event has subsided
Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding thestudy intervention administration or planned receipt of any vaccine (includingCOVID-19 vaccines) in the 4 weeks following the study intervention administrationexcept for influenza vaccination, which may be received at least 2 weeks before or 2weeks after the study intervention. This exception includes monovalent pandemicinfluenza 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 firstblood draw
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0320002
Buenos Aires, Ciudad De Buenos Aires 1430
ArgentinaSite Not Available
Investigational Site Number :0320002
Buenos Aires, Ciudad De Buenos Aires 1430
ArgentinaActive - Recruiting
Investigational Site Number : 0320001
Ciudad Autonoma Buenos Aires, C1425EFD
ArgentinaSite Not Available
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