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Safety and immunogenicity of an investigational Pentavalent Meningococcal ABCYW vaccine against meningococcal disease in children, toddlers, and infants
EU CTIS ID: 2023-510465-10-00
What this study is testing
- To describe the safety profile of the MenPenta vaccine formulations in healthy children (Stage 1), toddlers (Stage 2), and infants (Stage 3) - To describe the immune response to the MenPenta vaccine formulations and the comparator vaccines 30 days after the 2nd dose of vaccination given at approximately 4 months of age when administered to healthy infants in Stage 3 as measured by hSBA in the A, C, W-135, Y, and the reference MenB strains - To describe the immune response to the MenPenta vaccine formulations and the comparator vaccines 30 days after the 3rd dose of vaccination given at 12-15 MoA when administered to healthy infants in Stage 3 as measured by hSBA in the A, C, W-135, Y, and reference MenB strains - To describe immune response to MenPenta vaccine formulations and comparator vaccines at each time point when administered to healthy children (Stage 1) and toddlers (Stage 2) in A, C, W-135, Y, and reference MenB strains
- Therapeutic exploratory (Phase II)
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 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
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 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 meningococcal 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
- History of Guillain-Barré syndrome
- For Stage 3 infants: History of intussusception
See the full eligibility 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
- 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 meningococcal 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Honduras
- Brazil
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.
Where is this trial taking place?
Study sites include United Kingdom; Honduras; Brazil. Enter your location above to see the nearest site and check your eligibility.
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.