Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Studying a Vaccine for Meningococcal Disease in Kids
Study Overview
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age. The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in children (Stage 1) or concomitantly with routine pediatric vaccines in toddlers (Stage 2) and infants (Stage 3).
Study details include:
The study duration per participant will be up to 12 months for children in Stage 1 and toddlers in Stage 2 and 16 to-19 months for infants in Stage 3.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Meningococcal Immunization, Healthy Volunteers
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Age: 56 days - 9 years
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Gender: All
Inclusion Criteria:
- Aged 2 to 9 years (Stage 1) or 12 to 15 months (Stage 2) or 56 to 89 days (Stage 3) on the day of inclusion
- For infants and toddlers, born at full term of pregnancy (≥37 weeks) and with a birth weight ≥ 2.5 Kg or born after a gestation period of period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 Kg and in both cases medically stable as assessed by the investigator, based on the following definition: "Medically stable" refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study intervention
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgement of the investigator
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- 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 since birth for infants; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months or since birth for and infants)
- History of any meningitis infection, confirmed either clinically, serologically, or microbiologically
- At high risk of meningococcal infection during the study
- Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Individual with active tuberculosis
- History of Guillain-Barré syndrome
- For Stage 3 infants: History of intussusception
- Previous vaccination against meningococcal serogroups A, B, C, W, and/or Y with an investigational or marketed vaccine
- For Stage 3 infants: receipt of the first dose of rotavirus vaccine less than 28 days before the first trial vaccination
NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
This study investigates a meningococcal vaccine in children under 10 years old. Meningococcal disease is a serious illness caused by bacteria that can lead to infections in the brain and spinal cord. The purpose of this study is to compare two formulations of a new investigational vaccine with existing vaccines. Children will receive the vaccines either alone or with other routine vaccines, depending on their age group.
Participants will undergo specific study procedures, which include receiving the investigational vaccine or a licensed vaccine. The study is divided into three stages based on age groups: children, toddlers, and infants. Each participant's health will be monitored through medical evaluations, including checking their medical history and conducting physical exams.
- Who can participate: Children aged 2 to 9 years, toddlers aged 12 to 15 months, and infants aged 56 to 89 days may participate. Infants and toddlers must be born at full term or have specific birth weights if born prematurely. All participants should be in good health as determined by a medical evaluation.
- Study details: Participants will receive either the investigational vaccine or a licensed vaccine. The study includes medical evaluations such as checking medical history and physical exams. Infants and toddlers will receive the vaccines with routine pediatric vaccines.
- Study timelines: The study will last up to 12 months for children and toddlers, and 16 to 19 months for infants.
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