Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

Study on Vaccine Immune Response in Infants

Not Recruiting
6 months - 14 months
All
Phase 3
840 participants needed

Study Overview

This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.

Study Details

The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).

Eligibility Criteria

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

  • Conditions: Meningococcal Immunisation, Healthy Volunteers
  • Age: 6 months - 14 months
  • Gender: All

Inclusion Criteria:

  • Aged 6 to 7 months on the day of inclusion
  • Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment 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 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(s) 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. A 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) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.

Updated on 25 Mar 2025. Study ID: NCT06284915

This study investigates the immune response of a MenACYW conjugate vaccine compared to another vaccine, Nimenrix®. The purpose is to see if the MenACYW vaccine is not worse than Nimenrix® in creating an immune response in infants. The study involves healthy infants who have not received MenACWY vaccines before, with the first dose given at 6-7 months of age and a booster dose at 12-13 months.

Participants will receive two doses of the vaccine. The study will check how well the vaccines work and their safety. The vaccines aim to protect against meningococcal disease, a serious illness caused by bacteria. The study will involve medical evaluations, including checking the medical history and physical health of the participants.

  • Who can participate: Infants aged 6 to 7 months who are healthy and have not previously received MenACWY vaccines can participate. Participants should not have any known immune deficiencies or a history of meningococcal infection.
  • Study details: Participants will receive two doses of a vaccine. The first dose is given at 6-7 months, and the second dose at 12-13 months. The study will monitor the safety and immune response to the vaccine.
  • Study timelines: The study will last approximately 7 to 8.5 months.