Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants

  • STATUS
    Recruiting
  • End date
    Dec 3, 2025
  • participants needed
    1800
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 27 October 2022
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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
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 IdentifierNCT04825223
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on27 October 2022

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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