Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy

Studying the Immune Response and Safety of a Booster Vaccine in Young Children

Not Recruiting
12 months - 23 months
All
Phase 4
71 participants needed

Study Overview

This study will evaluate 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 will receive a single dose of MenQuadfi® at Visit 1. Participants will provide 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments.

Study will include 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.

Study Details

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

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Meningococcal Immunisation, Healthy Volunteers
  • Age: 12 months - 23 months
  • Gender: All

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

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

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

Updated on 25 Sep 2024. Study ID: NCT05929651

This study investigates the immune response and safety of a booster vaccine in toddlers aged 12 to 23 months in Argentina. The study focuses on children who have previously received at least one dose of a quadrivalent meningococcal conjugate vaccine during infancy to protect against invasive meningococcal disease (IMD). IMD is a serious infection caused by bacteria, which can lead to conditions like meningitis.

Participants will receive a single dose of the investigational vaccine at the first visit. Two blood samples will be taken: one before the vaccination and another one month after the vaccination to assess the immune response. The study involves two visits and a follow-up phone call to monitor safety.

  • Who can participate: Toddlers aged 12 to 23 months who are healthy and have received at least one dose of a licensed quadrivalent meningococcal conjugate vaccine during infancy are eligible. Participants must have had an interval of at least 2 months since their last vaccination.
  • Study details: Participants will receive a single dose of the investigational vaccine. Blood samples will be collected before and after vaccination to evaluate immune response. A follow-up phone call will be conducted to monitor safety.
  • Study Timelines and Visits: The study will last 30 days. The study requires 2 visits.