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

NCT04825223 | Terminated Phase 1 FDA Drug

• 4 other identifiers: VAN00002U1111-1244-03772023-506970-112021-003070-31
• Study Type: interventional
• Target: 576
• Locations: 2 countries
• Sites: 10

Brief Summary

Primary Objective:

• 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

Conditions

Meningococcal Immunisation; Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• Number of participants with immediate adverse events (AEs)

  Unsolicited systemic AEs that occur within 30 minutes after vaccination

  Within 30 minutes after vaccination

• Number of participants with solicited injection site reactions or systemic reactions

  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)

  Within 7 days after vaccination

• Number of participants with unsolicited AEs

  AEs that do not fulfill the conditions of solicited reactions

  Within 30 days after vaccination

• Number of participants with serious adverse events (SAEs)

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

  Up to 6 months after last vaccination

• Number of participants with medically attended adverse events (MAAE)s

  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

  Up to 6 months after last vaccination

• Number of participants with out-of-range biological test results

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

  From baseline (pre-vaccination) up to Day 07 (post-vaccination)

• Antibody titers in the primary panel of MenB strains before primary vaccination

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

  Day 01 (pre-vaccination)

• Antibody titers in the primary panel of MenB strains after primary vaccination

  Antibody titers measured by hSBA

  Day 30 (post-vaccination)

Secondary Outcomes (4)

• 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 in the secondary panel of MenB strains (stage 1 and 2 only)

  Day 01 (pre-vaccination) and Day 30 (post-vaccination)

• Antibody titers in the primary panel of MenB strains (stage 2 only)

  Day 366 (pre-vaccination) and Day 396 (post-vaccination)

• Antibody titers against each of Men A, C, W, and Y strains

  Day 01 (pre-vaccination) and Day 30 (post-vaccination)

Study Arms (8)

Stage 1: MenB vaccine formulation(s)

EXPERIMENTAL

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; Drug: Placebo

Stage 1: vaccine comparator(s)

ACTIVE COMPARATOR

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; Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed); Drug: Placebo

Stage 2: MenB vaccine formulation(s)

EXPERIMENTAL

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; Drug: Placebo; Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Stage 2: vaccine comparator(s)

ACTIVE COMPARATOR

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; Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed); Drug: Placebo

Stage 3: Men B vaccine formulation(s)

EXPERIMENTAL

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; Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Stage 3: MenQuadfi vaccine and vaccine comparator

ACTIVE 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); Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Stage 4: MenB vaccine formulation(s)

EXPERIMENTAL

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; Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Stage 4: MenQuadfi vaccine and vaccine comparator

ACTIVE 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); Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine

Interventions

Multicomponent Meningococcal B Vaccine DRUG

Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular

Also known as: Trumenba®

Stage 1: vaccine comparator(s); Stage 2: vaccine comparator(s)

Meningococcal Group B Vaccine MenB DRUG

Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular

Also known as: MenB

Stage 1: MenB vaccine formulation(s); Stage 2: MenB vaccine formulation(s); Stage 3: Men B vaccine formulation(s); Stage 4: MenB vaccine formulation(s)

Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) DRUG

Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular

Also known as: Bexsero®

Stage 1: vaccine comparator(s); Stage 2: vaccine comparator(s); Stage 3: MenQuadfi vaccine and vaccine comparator; Stage 4: MenQuadfi vaccine and vaccine comparator

Placebo DRUG

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

Stage 1: MenB vaccine formulation(s); Stage 1: vaccine comparator(s); Stage 2: MenB vaccine formulation(s); Stage 2: vaccine comparator(s)

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine DRUG

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

Also known as: MenQuadfi™

Stage 2: MenB vaccine formulation(s); Stage 3: Men B vaccine formulation(s); Stage 3: MenQuadfi vaccine and vaccine comparator; Stage 4: MenB vaccine formulation(s); Stage 4: MenQuadfi vaccine and vaccine comparator

Eligibility Criteria

• Age: 42 Days - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 - - -

You may not qualify if:

• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (10)

Lakeview Clinical Research Site Number : 8400029

Guntersville, Alabama, 35976-2206, United States

Location

California Research Foundation Site Number : 8400005

San Diego, California, 92123-1881, United States

Location

PAS Research Site Number : 8400032

Tampa, Florida, 33613, United States

Location

Brengle Family Medicine Site Number : 8400044

Indianapolis, Indiana, 46260, United States

Location

AMR El Dorado Site Number : 8400018

El Dorado, Kansas, 67042, United States

Location

Alliance for Multispecialty Research LLC Site Number : 8400013

Wichita, Kansas, 67205, United States

Location

Prime Global Research, Inc. Site Number : 8400043

The Bronx, New York, 10456, United States

Location

The Research Center of the Upstate Site Number : 8400008

Greenville, South Carolina, 29607, United States

Location

Investigational Site Number : 6300003

Ponce, 00716, Puerto Rico

Location

Investigational Site Number : 6300001

San Juan, 00918, Puerto Rico

Location

Related Links

• VAN00002 Plain Language Results Summary

MeSH Terms

Interventions

MenB-FHbp vaccine; 4CMenB vaccine; DNA, Recombinant; DNA, Ribosomal; Elements

Intervention Hierarchy (Ancestors)

DNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Inorganic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 groups

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: March 29, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (8); PR (2)