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Study on immunogenicity and safety of a meningococcal ACYW conjugate vaccine in healthy infants and toddlers
EU CTIS ID: 2023-508177-85-00
What this study is testing
- To demonstrate non-inferiority of the antibody response in terms of geometric mean titers (GMTs) against meningococcal serogroups A, C, W, and Y, following the administration of a 2-dose series (1+1) of MenACYW conjugate vaccine compared to a 2 - dose series (1+1) of Nimenrix®, when each vaccine is administered to infants (dose 1) at 6-7 months of age and toddlers (dose 2) at 12-13 months of age - To demonstrate non inferiority of the antibody response in terms of vaccine seroresponse against meningococcal serogroups A, C, W, and Y, following the administration of a 2-dose series (1+1) of MenACYW conjugate vaccine compared to a 2-dose series (1+1) of Nimenrix®, when each vaccine is administered to infants (Dose 1) at 6-7 months of age and toddlers (Dose 2) at 12-13 months of age
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.