Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

STATUS

Recruiting
End date

Jul 23, 2025
participants needed

1800
sponsor

Sanofi Pasteur, a Sanofi Company

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Updated on 19 February 2024

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Accepts healthy volunteers

Summary

Primary Objective:

To describe the safety profile of the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines in healthy adults, adolescents, toddlers and infants, when administered alone (Stages 1-4) or concomitantly with MenQuadfiTM (MenACYW conjugate vaccine) (for Stages 2-4 only), and with age-appropriated routine pediatric vaccines (for Stages 3-4 only)
1. To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;
2. To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;
3. To describe the safety profile of the SP MenB vaccine formulations,
when administered alone
when administered with MenQuadfiTM (MenACYW conjugate vaccine)
when administered with routine infant immunizations
To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines after the last dose of primary vaccination in healthy adults, adolescents, toddlers and infants, when administered alone, or concomitantly with MenQuadfi Vaccine or other routine vaccines, as measured by the serum bactericidal assay using human complement (hSBA) in the primary panel of MenB strains by Stage, by age group and by vaccine schedule

Secondary Objective:

To describe the immune response to the SP MenB vaccine formulations and the 2 licensed MenB comparator vaccines at each timepoint in healthy adults, adolescents, toddlers and infants, when administered alone or concomitantly with MenQuadfi Vaccine or other routine vaccines as measured by hSBA in the primary panel of MenB strains by Stage by age group and by vaccine schedule
To describe the immune response (breadth of coverage) in the secondary panel of MenB strains in participants (adults and adolescents) in Stage 1 and 2 after the last dose of the primary series in each group
To describe the persistence of immune response following primary series at D366, and immune response 1 month after a booster dose of the SP MenB vaccine given 1-year post-dose 1 (at D366) in a subset of adults and adolescents in Stage 2 who received SP MenB vaccine formulations, Bexsero Vaccine or Trumenba Vaccine as measured by hSBA in the primary panel of MenB strains by age group
To describe the immune response against meningococcal serogroups A, C, W and Y measured with hSBA in participants from each agegroup receiving MenQuadfi Vaccine

Description

Study duration per participant will be approximately: 7 months for Stage 1 participants, 12 to 18.5 months for Stage 2 participants, 12 months for Stage 3 participants and 18 months for Stage 4 participants

In each vaccine group at each age group (Stage 1, 3 and 4 only), the first 5 participants enrolled (sentinels) will be assessed via early safety data review (ESDR) as a cohort for the evaluation of biological safety and overall safety profile for D01-D08 post dose 1. The safety data collected will be reviewed before proceeding with recruitment of remaining participants in each study group. Enrollment of remaining participants randomized to each group will be based on the outcome of the safety assessments of the sentinels: only a positive review outcome will allow the enrollment of the sentinel cohort of the respective lower age group.

Details

Condition	Meningococcal Immunisation
Age	42days - 50year
Treatment	Placebo, Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine, Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB, Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
Clinical Study Identifier	NCT04825223
Sponsor	Sanofi Pasteur, a Sanofi Company
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	For US: Aged 10 to 25 years on the day of inclusion ("10-25 years" means from the day of
	the 10th birthday to the day before the 26th birthday) For EU: Aged 42 to 89 days or 12 to
	months or 10 to 50 years on the day of inclusion ("42 to 89 days" means from 42 days
	after birth to the 89th day after birth; "12-18 months" means from the12th month after
	birth to the day before the 19th month after birth; "10-50 years" means from the day of the
	th birthday to the day before the 51st birthday Participants or participant and
	parent/legally acceptable representative are able to attend all scheduled visits and to
	comply with all trial procedures Covered by health insurance (applicable depending on local
	regulations) Participants who are overtly healthy as determined by medical evaluation
	including medical history, physical examination, and judgement of the Investigator
	For adults: A female participant is eligible to participate if she is not pregnant or
	breastfeeding and one of the following conditions applies
	Is of non-childbearing potential. To be considered of non-childbearing potential, a
	female must be post-menopausal for at least 1 year, or surgically sterile OR
	Is of childbearing potential and agrees to use an effective contraceptive method or
	abstinence from at least 4 weeks prior to the first study intervention administration
	until at least 4 weeks after the last study intervention administration
	A female participant of childbearing potential must have a negative highly sensitive
	pregnancy test (urine or serum as required by local regulation) the day of any dose of
	study intervention
	For adolescents: A female participant is eligible to participate if she is not pregnant or
	breastfeeding and one of the following conditions applies
	Is of non-childbearing potential. To be considered of non-childbearing potential, a
	female must be pre-menarche OR
	Is of childbearing potential and agrees to use an effective contraceptive method or
	abstinence from at least 4 weeks prior to the first study intervention administration
	until at least 4 weeks after the last study intervention administration A female
	participant of childbearing potential must have a negative highly sensitive pregnancy
	test (urine or serum as required by local regulation) the day of any dose of study
	intervention -For infants: Born at full term of pregnancy (≥37 weeks) and with a birth
	weight ≥2.5 kg or born after a gestation period of 27 through 36 weeks and 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 - - -
Exclusion Criteria
	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 and toddlers; or long-term systemic
	corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within
	the past 3 months or since birth for infants and toddlers) History of any Neisseria
	meningitidis infection, confirmed either clinically, serologically, or microbiologically At
	high risk for meningococcal infection during the trial (specifically, but not limited to
	participants with persistent complement deficiency, with anatomic or functional asplenia
	or participants travelling to countries with high endemic or epidemic disease) Individuals
	with active tuberculosis Known systemic hypersensitivity to latex or to any of the vaccine
	components, or history of a life-threatening reaction to the vaccine(s) used in the trial
	or to a vaccine containing any of the same substances For adults and adolescents
	Self-report of thrombocytopenia, contraindicating intra-muscular (IM) vaccination For
	infants and toddlers: Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as
	reported by the parent/legally acceptable representative contraindicating intramuscular
	vaccination Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
	inclusion, contraindicating IM vaccination For infants and toddlers: History of
	intussusception Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial
	vaccination or planned receipt of any vaccine 4 weeks before to 4 weeks after each trial
	vaccination or study visit with collection of blood for immunogenicity assessments, except
	for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after
	any study vaccination. This exception includes monovalent pandemic influenza vaccines and
	multivalent influenza vaccines Previous vaccination against meningococcal B disease with
	either the study vaccines or another licensed or investigational vaccine (i.e., mono- or
	polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroup B) For
	infants and toddlers: Previous vaccination against meningococcal disease with either the
	study vaccines or any other licensed or investigational vaccine containing serogroups A, C
	W, Y; or meningococcal serogroup B Receipt of immune globulins, blood or blood-derived
	products in the past 3 months or since birth for infants and toddlers Receipt of oral or
	injectable antibiotic therapy within 72 hours prior to the first immunogenicity blood draw
	For infants: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis
	hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b
	Streptococcus pneumoniae, and /or rotavirus infection or disease, and receipt of more than
	previous dose of hepatitis B vaccine Participation at the time of study enrollment (or in
	the 4 weeks preceding the first trial vaccination) or planned participation during the
	present trial period in another clinical trial investigating a vaccine, drug, medical
	device, or medical procedure Chronic illness that, in the opinion of the investigator, is
	at a stage where it might interfere with trial conduct or completion Moderate or severe
	acute illness/infection (according to the investigator's judgment), febrile illness
	(temperature ≥ 38.0°C or ≥ 100.4°F). A prospective participant should not be enrolled in
	the study until the condition has resolved or the febrile event has subsided History of
	Guillain-Barré syndrome History of any neurologic disorders, including any seizures and
	progressive neurologic disorders Deprived of freedom by an administrative or court order
	or in an emergency setting, or hospitalized involuntarily For adults and adolescents
	Identified as an investigator or employee of the investigator or study center with direct
	involvement in the proposed study, or identified as an immediate family member (i.e
	parent, spouse, natural or adopted child) of the investigator or employee with direct
	involvement in the proposed study For infants and toddlers: Identified as a natural or
	adopted child of the Investigator or employee with direct involvement in the proposed study
	For adults and adolescents: Alcohol, prescription drug, or substance abuse that, in the
	opinion of the Investigator, might interfere with the study conduct or completion
	The above information is not intended to contain all considerations relevant to a patient's
	potential participation in a clinical trial

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Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

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Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants

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Description

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Study Definition

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