BridgeMD
MENACWY=MEN7B-003
EU CTIS ID: 2023-506449-40-00
What this study is testing
To evaluate the safety and reactogenicity of the 2 formulations of MenABCWY-2nd Gen vaccine, the MenABCWY-1st Gen, the MenB vaccine and the MenACWY-TT vaccine. To assess the immune response to the 2 formulations of MenABCWY-2nd Gen vaccine, to the MenABCWY-1st Gen and to the MenB vaccine against all serogroup B indicator strains To assess the immune response to the 2 formulations of MenABCWY-2nd Gen vaccine, to the MenABCWY-1st Gen vaccine and to the MenACWY-TT vaccine against serogroups A, C, W and Y
- Phase I and Phase II (Integrated)- Other
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
- Participants’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
- Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.
You likely can't join if
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Any neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
- Congenital or peripartum disorders resulting in a chronic condition (including but not limited to chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
- Major congenital defects, as assessed by the investigator
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
See the full eligibility criteria
- Participants’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
- Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.
- Current or previous, confirmed or suspected disease caused by N. meningitidis.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Any neuroinflammatory disorders (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital and peripartum neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple seizures or febrile convulsions).
- Congenital or peripartum disorders resulting in a chronic condition (including but not limited to chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
- Major congenital defects, as assessed by the investigator
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
- Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).
- Child in care.
- Study personnel as an immediate family or household member.
- For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.
- Abnormal function or modification of the immune system resulting from: - Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes). - Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed. - Administration of antineoplastic and immunomodulating agents or radiotherapy from birth. - Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab)..
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines from birth, or planned use during the study period.
- Previous vaccination with any meningococcal vaccine.
- Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
- Progressive, unstable or uncontrolled clinical conditions.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
- Dominican Republic
- 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 South Africa; Dominican Republic; 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.