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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

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04825223
Collaborator
(none)
1,800
Enrollment
22
Locations
8
Arms
55
Anticipated Duration (Months)
81.8
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Multicomponent Meningococcal B Vaccine
  • Drug: Meningococcal Group B Vaccine MenB
  • Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
  • Drug: Placebo
  • Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
 Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
The study will be conducted in 4 stages, sequentially: Stage 1: adults and adolescents from the US, equally randomized to 8 vaccine groups Stage 2; adults and adolescents from the EU and the US, equally randomized to 11 vaccine groups Stage 3: toddlers from the EU, equally randomized to 6 vaccine groups Stage 4: infants from the EU, equally randomized to 6 vaccine groupsThe study will be conducted in 4 stages, sequentially:Stage 1: adults and adolescents from the US, equally randomized to 8 vaccine groups Stage 2; adults and adolescents from the EU and the US, equally randomized to 11 vaccine groups Stage 3: toddlers from the EU, equally randomized to 6 vaccine groups Stage 4: infants from the EU, equally randomized to 6 vaccine groups
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Stage 1 and Stage 2 (adults and adolescents) will be modified double-blind: the investigators and study staff who conduct the safety assessment and the participant will not know which vaccine is administered. Only the study staff who prepare and administer the vaccine and are not involved with the safety evaluation will know which vaccine is administered. The individual(s) responsible for the preparation / administration of the vaccines will not be authorized to collect any safety or serology data. Testing laboratories will be blinded. In order to maintain the blind in Stage 2 (adults and adolescents), a placebo injection will be used. After the 6-months safety assessment from the last dose of primary vaccination, Stage 2 will be unblinded for the administration of booster vaccinations. Stage 3 and Stage 4 (toddlers and infants) will be open-label.
Primary Purpose:
Treatment
Official Title:
Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
Actual Study Start Date :
Mar 29, 2021
Anticipated Primary Completion Date :
Oct 29, 2025
Anticipated Study Completion Date :
Oct 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stage 1: MenB vaccine formulation(s)

Assigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181

Drug: Meningococcal Group B Vaccine MenB
Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
Other Names:
  • MenB

    • Drug: Placebo
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Active Comparator: Stage 1: vaccine comparator(s)

    Bexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181

    Drug: Multicomponent Meningococcal B Vaccine
    Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular
    Other Names:
  • Trumenba®

    • Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • Bexsero®

    • Drug: Placebo
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Experimental: Stage 2: MenB vaccine formulation(s)

    Assigned MenB vaccine formulation, MenQuadfi vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of leading MenB vaccine formulation single injection at Day 366

    Drug: Meningococcal Group B Vaccine MenB
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • MenB

    • Drug: Placebo
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular

    Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Other Names:
  • MenQuadfi™

    		•
    Active Comparator: Stage 2: vaccine comparator(s)

    Bexsero vaccine or Trumenba vaccine and Placebo single injection in the respective dosing schedule at Day 01, Day 31, Day 61 and Day 181 + booster dose of Bexsero vaccine single injection at Day 366

    Drug: Multicomponent Meningococcal B Vaccine
    Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular
    Other Names:
  • Trumenba®

    • Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • Bexsero®

    • Drug: Placebo
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Experimental: Stage 3: Men B vaccine formulation(s)

    Assigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61

    Drug: Meningococcal Group B Vaccine MenB
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • MenB

    • Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Other Names:
  • MenQuadfi™

    		•
    Active Comparator: Stage 3: MenQuadfi vaccine and vaccine comparator

    MenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61

    Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • Bexsero®

    • Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Other Names:
  • MenQuadfi™

    		•
    Experimental: Stage 4: MenB vaccine formulation(s)

    Assigned MenB vaccine formulation, Routine Vaccines (RV)s and MenQuadfi vaccine single injection in the respective dosing at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa

    Drug: Meningococcal Group B Vaccine MenB
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • MenB

    • Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Other Names:
  • MenQuadfi™

    		•
    Active Comparator: Stage 4: MenQuadfi vaccine and vaccine comparator

    MenQuadfi vaccine or Bexsero vaccine and RVs in the respective dosing schedule at 2 months of ages [moa] (Day 01), 4moa (Day 61) and 12 moa

    Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
    Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
    Other Names:
  • Bexsero®

    • Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
    Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
    Other Names:
  • MenQuadfi™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with immediate adverse events (AEs) [Within 30 minutes after vaccination]

      Unsolicited systemic AEs that occur within 30 minutes after vaccination

    2. Number of participants with solicited injection site reactions or systemic reactions [Within 7 days after vaccination]

      Adverse reactions pre-listed in the protocol and case report form (CRF) Injection site reactions: pain, erythema and swelling (or tenderness, erythema and swelling for infants and toddlers) Systemic reactions: fever, headache, malaise, myalgia (or fever, vomiting, crying abnormal, drowsiness, appetite lost, irritability for infants and toddlers)

    3. Number of participants with unsolicited AEs [Within 30 days after vaccination]

      AEs that do not fulfill the conditions of solicited reactions

    4. Number of participants with serious adverse events (SAEs) [Up to 6 months after last vaccination]

      SAEs reported throughout the study, including adverse events of special interest (AESI)s

    5. Number of participants with medically attended adverse events (MAAE)s [Up to 6 months after last vaccination]

      AEs with a new onset or a worsening of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or Emergency Department

    6. Number of participants with out-of-range biological test results [From baseline (pre-vaccination) up to Day 07 (post-vaccination)]

      Out-of-range biological test results occurring in the sentinel cohorts of each age group

    7. Antibody titers in the primary panel of MenB strains before primary vaccination [Day 01 (pre-vaccination)]

      Antibody titers measured by serum bactericidal assay using human complement (hSBA)

    8. Antibody titers in the primary panel of MenB strains after primary vaccination [Day 30 (post-vaccination)]

      Antibody titers measured by hSBA

    Secondary Outcome Measures

    1. Antibody titers in the primary panel of MenB strains after each vaccination [Day 01, Day 31, Day 61, Day 91, Day 181, Day 211, Day 366 and Day 396]

      Antibody titers measured by hSBA

    2. Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only) [Day 01 (pre-vaccination) and Day 30 (post-vaccination)]

      Antibody titers measured by hSBA

    3. Antibody titers in the primary panel of MenB strains (stage 2 only) [Day 366 (pre-vaccination) and Day 396 (post-vaccination)]

      Antibody titers measured by hSBA

    4. Antibody titers against each of Men A, C, W, and Y strains [Day 01 (pre-vaccination) and Day 30 (post-vaccination)]

      Antibody titers measured by hSBA in participants receiving MenQuadfi vaccine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    42 Days to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 18 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 10th 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 1 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lakeview Clinical Research-Site Number:8400029 Guntersville Alabama United States 35976
    2 Hope Clinical Research, Inc.-Site Number:8400001 Canoga Park California United States 91301
    3 WCCT Global, Inc.-Site Number:8400015 Cypress California United States 90630
    4 California Research Foundation-Site Number:8400005 San Diego California United States 92123-1881
    5 SIMEDHealth, LLC-Site Number:8400045 Gainesville Florida United States 32605
    6 MD Clinical-Site Number:8400027 Hallandale Beach Florida United States 33009
    7 Moore Clinical Research Inc-Site Number:8400030 Tampa Florida United States 33609
    8 PAS Research, LLC-Site Number:8400032 Tampa Florida United States 33613
    9 Advanced Clinical Research - Magic View-Site Number:8400024 Meridian Idaho United States 83642
    10 Brengle Family Medicine-Site Number:8400044 Indianapolis Indiana United States 46260
    11 AMR El Dorado-Site Number:8400018 El Dorado Kansas United States 67042
    12 Alliance for Multispecialty Research, LLC-Site Number:8400013 Wichita Kansas United States 67205
    13 AMR Wichita East-Site Number:8400012 Wichita Kansas United States 67207
    14 Kentucky Pediatric Research Inc-Site Number:8400009 Bardstown Kentucky United States 40004
    15 AMR Lexington-Site Number:8400002 Lexington Kentucky United States 40509
    16 Michael W. Simon, MD, PSC-Site Number:8400026 Lexington Kentucky United States 40517
    17 Prime Global Research, Inc.-Site Number:8400043 New York New York United States 10456
    18 The Research Center of the Upstate-Site Number:8400008 Greenville South Carolina United States 29607
    19 Pediatric Clinical Trials Tullahoma-Site Number:8400020 Tullahoma Tennessee United States 37388
    20 Progressive Clinical Research-Site Number:8400028 Bountiful Utah United States 84010
    21 Investigational Site Number :6300003 Ponce Puerto Rico 00716
    22 Investigational Site Number :6300001 San Juan Puerto Rico 00918

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT04825223
    Other Study ID Numbers:
    • VAN00002
    • U1111-1244-0377
    First Posted:
    Apr 1, 2021
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Vaccines

    Study Results

    No Results Posted as of Jul 26, 2022