Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MenACWY-7B low dose vaccine · 1 trial · 1 indication
The solicited administration site events include tenderness (administration site pain), erythema (redness), induration and swelling. Any solicited administration site events = occurrence of the event regardless of intensity grade. Data for solicited administration site events is presented for each intervention administered in each arm group.
The solicited systemic events included diarrhoea, drowsiness (somnolence), fever (pyrexia), irritability/fussiness, loss of appetite, and vomiting. Fever is defined as temperature \>38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Assessed unsolicited AEs include serious adverse events (SAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and medically attended AEs (MAAEs). Any = occurrence of the event regardless of the intensity grade.
MAAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. AEs leading to withdrawal are defined as AEs due which the participant is considered to have withdrawn from the study as no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine was evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains fHbp, NadA, NHBA, PorA, fHbp V1.13, fHbp V2 and fHbp V3.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y.
The immune response to the MenACWY-7B vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs.
| Arm | Type | Description |
|---|---|---|
| MenACWY-7B low dose Group | EXPERIMENTAL | Participants received a single dose of the MenACWY-7B low dose vaccine on Day 1, Day 61 and Day 301. |
| MenB+MenACWY-TT Group | ACTIVE_COMPARATOR | Participants received a single dose of the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine on Day 1, Day 61 and Day 301. |
| MenACWY-7B high dose Group | EXPERIMENTAL | Participants received a single dose of the MenACWY-7B high dose vaccine on Day 1, Day 61 and Day 301. |
| ABCWY-1Gen Group | EXPERIMENTAL | Participants received a single dose of the MenABCWY-1Gen vaccine on Day 1, Day 61 and Day 301. |
| Name | Type | Description |
|---|---|---|
| MenACWY-7B low dose vaccine | COMBINATION_PRODUCT | MenACWY-7B low dose vaccine is administered intramuscularly in the upper thigh region of the right leg. |
| MenACWY-7B high dose vaccine | COMBINATION_PRODUCT | MenACWY-7B high dose vaccine is administered intramuscularly in the upper thigh region of the right leg. |
| MenABCWY-1Gen vaccine | COMBINATION_PRODUCT | MenABCWY-1Gen vaccine is administered intramuscularly in the upper thigh region of the right leg. |
| MenB vaccine | COMBINATION_PRODUCT | MenB vaccine is administered intramuscularly in the upper thigh region of the right leg. |
| MenACWY-TT vaccine | COMBINATION_PRODUCT | MenACWY-TT vaccine is administered intramuscularly in the lower thigh region of the right leg. |
Inclusion 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 particip...
MenACWY-7B low dose vaccine is an investigational vaccine being studied for the prevention of meningococcal infections. It is designed to protect against meningococcal disease caused by serogroups A, C, W, and Y, and is being evaluated in healthy infants.
MenACWY-7B low dose vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's safety and immune response in infants.
MenACWY-7B low dose vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the vaccine remains under clinical evaluation.
MenACWY-7B low dose vaccine has been studied in one completed Phase 2 trial, NCT05082285, which evaluated the safety, tolerability, and immune response of a meningococcal combined ABCWY vaccine in healthy infants. The trial enrolled 726 participants across multiple countries.
MenACWY-7B low dose vaccine is being studied as part of a meningococcal combined ABCWY vaccine. The Phase 2 trial NCT05082285 assessed a vaccine targeting serogroups A, B, C, W, and Y, with MenACWY-7B low dose being a component of this combination.