A Descriptive, Phase IV, Open-label, Single-arm Multi-center Study to Assess the Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Healthy Toddlers 12 to 23 Months of Age Who Had Been Primed With at Least 1 Dose of Another Quadrivalent Meningococcal Conjugate Vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in Infancy.

CompletadoFase 4ClinicalTrials.gov

ID: NCT05929651Tipo: INTERVENTIONALInicio: 7 de sept de 2023Fin estimado: 9 de sept de 2024

Traducción no disponible, mostrando original

Resumen

This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.

Descripción detallada

Study duration was approximately 30 days (+14 days) per participant

Elegibilidad

Edad mínima: 12 MonthsEdad máxima: 23 MonthsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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
NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

biological

MenACYW conjugate vaccine

Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection

Ubicaciones

Investigational Site Number : 0320002

Buenos Aires, Buenos Aires F.D., Argentina

Investigational Site Number : 0320001

Ciudad Autonoma Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi Pasteur, a Sanofi Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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