Meningococcal ImmunisationPhase 1NCT04825223
Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants
A Phase 1 study testing Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB and Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 10 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 42 days to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Immunisation, Healthy Volunteers
- What is being tested?
- Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB and Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 576 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 29 Mar 2021to 22 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 days to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -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 - - -
Who cannot join
- -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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
AMR El Dorado Site Number : 8400018
El Dorado, Kansas, 67042
The Research Center of the Upstate Site Number : 8400008
Greenville, South Carolina, 29607
Lakeview Clinical Research Site Number : 8400029
Guntersville, Alabama, 35976-2206
Brengle Family Medicine Site Number : 8400044
Indianapolis, Indiana, 46260
California Research Foundation Site Number : 8400005
San Diego, California, 92123-1881
PAS Research Site Number : 8400032
Tampa, Florida, 33613
Prime Global Research, Inc. Site Number : 8400043
The Bronx, New York, 10456
Alliance for Multispecialty Research LLC Site Number : 8400013
Wichita, Kansas, 67205
Puerto Rico2 sites
Investigational Site Number : 6300003
Ponce, 00716
Investigational Site Number : 6300001
San Juan, 00918
About this study
Official title: Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
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)
Read more
- To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;
- To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;
- 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
Read the 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.
- Conditions
- Meningococcal Immunisation, Healthy Volunteers
- Being tested
- Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB, Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Placebo, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Meningococcal B VaccineDrug
Also called Trumenba®
Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular
Meningococcal Group B Vaccine MenBDrug
Also called MenB
Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)Drug
Also called Bexsero®
Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
PlaceboDrug
Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccineDrug
Also called MenQuadfi™
Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with immediate adverse events (AEs)
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Measured: 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)
Measured: Within 7 days after vaccination
Number of participants with unsolicited AEs
AEs that do not fulfill the conditions of solicited reactions
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 01 (pre-vaccination)
Antibody titers in the primary panel of MenB strains after primary vaccination
Antibody titers measured by hSBA
Measured: Day 30 (post-vaccination)
Secondary outcomes (4)
Antibody titers in the primary panel of MenB strains after each vaccination
Antibody titers measured by hSBA
Measured: 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)
Antibody titers measured by hSBA
Measured: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains (stage 2 only)
Antibody titers measured by hSBA
Measured: Day 366 (pre-vaccination) and Day 396 (post-vaccination)
Antibody titers against each of Men A, C, W, and Y strains
Antibody titers measured by hSBA in participants receiving MenQuadfi vaccine
Measured: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start29 Mar 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Why it stopped: Sponsor decision. Termination decision not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal ImmunisationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825223
- Sponsor's protocol ID
- VAN00002
- Other IDs
- U1111-1244-0377, 2023-506970-11, 2021-003070-31, 2023
- Status last verified
- Oct 2025
- First submitted
- 25 Mar 2021
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of an Investigational Multicomponent Meningococcal Group B Vaccine in Adults, Adolescents, Toddlers, and Infants
- ClinicalTrials.gov ID
- NCT04825223
- Acronym / sponsor ID
- VAN00002
- Conditions
- Meningococcal Immunisation, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision. Termination decision not related to any safety concern.
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- To describe the safety profile of the SP MenB vaccine formulations, Bexsero Vaccine and Trumenba Vaccine in healthy adults, and adolescents;
- To describe the safety profile of the SP MenB vaccine formulations and Bexsero Vaccine in toddlers and infants;
- 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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- 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 groups
| Arm | Type | Receives |
|---|---|---|
| Stage 1: MenB vaccine formulation(s) | Experimental | Drug: Meningococcal Group B Vaccine MenB, Drug: PlaceboAssigned MenB vaccine formulation or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 |
| Stage 1: vaccine comparator(s) | Active comparator | Drug: Multicomponent Meningococcal B Vaccine, Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Drug: PlaceboBexsero vaccine or Trumenba vaccine or Placebo single injection in the respective dosing schedule at Day 01, Day 31 and Day 181 |
| Stage 2: MenB vaccine formulation(s) | Experimental | Drug: Meningococcal Group B Vaccine MenB, Drug: Placebo, Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccineAssigned 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 |
| Stage 2: vaccine comparator(s) | Active comparator | Drug: Multicomponent Meningococcal B Vaccine, Drug: Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed), Drug: PlaceboBexsero 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 |
| Stage 3: Men B vaccine formulation(s) | Experimental | Drug: Meningococcal Group B Vaccine MenB, Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccineAssigned MenB vaccine formulation and/or MenQuadfi vaccine single injection in the respective dosing schedule at Day 01 and Day 61 |
| Stage 3: MenQuadfi vaccine and vaccine comparator | Active comparator | 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 vaccineMenQuadfi vaccine single injection at Day 01 or Bexsero vaccine single injection at Day 01 and Day 61 |
| Stage 4: MenB vaccine formulation(s) | Experimental | Drug: Meningococcal Group B Vaccine MenB, Drug: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccineAssigned 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 |
| Stage 4: MenQuadfi vaccine and vaccine comparator | Active comparator | 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 vaccineMenQuadfi 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 |
Who may qualify
- Ages
- 42 days to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- -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
Key exclusion criteria (2 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multicomponent Meningococcal B VaccineAlso: Trumenba®Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular | Drug | Stage 1: vaccine comparator(s), Stage 2: vaccine comparator(s) |
| Meningococcal Group B Vaccine MenBAlso: MenBPharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular | Drug | 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)Also: Bexsero®Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular | Drug | Stage 1: vaccine comparator(s), Stage 2: vaccine comparator(s), Stage 3: MenQuadfi vaccine and vaccine comparator, Stage 4: MenQuadfi vaccine and vaccine comparator |
| PlaceboPharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular | Drug | 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 vaccineAlso: MenQuadfi™Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular | Drug | 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 |
Primary outcome
Number of participants with immediate adverse events (AEs)
Time frame: Within 30 minutes after vaccination
Unsolicited systemic AEs that occur within 30 minutes after vaccination
Number of participants with solicited injection site reactions or systemic reactions
Time frame: 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)
Number of participants with unsolicited AEs
Time frame: Within 30 days after vaccination
AEs that do not fulfill the conditions of solicited reactions
Number of participants with serious adverse events (SAEs)
Time frame: Up to 6 months after last vaccination
SAEs reported throughout the study, including adverse events of special interest (AESI)s
Number of participants with medically attended adverse events (MAAE)s
Time frame: 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
Number of participants with out-of-range biological test results
Time frame: 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
Antibody titers in the primary panel of MenB strains before primary vaccination
Time frame: Day 01 (pre-vaccination)
Antibody titers measured by serum bactericidal assay using human complement (hSBA)
Antibody titers in the primary panel of MenB strains after primary vaccination
Time frame: Day 30 (post-vaccination)
Antibody titers measured by hSBA
4 secondary outcomes
Antibody titers in the primary panel of MenB strains after each vaccination
Time frame: 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)
Time frame: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
Antibody titers in the primary panel of MenB strains (stage 2 only)
Time frame: Day 366 (pre-vaccination) and Day 396 (post-vaccination)
Antibody titers against each of Men A, C, W, and Y strains
Time frame: Day 01 (pre-vaccination) and Day 30 (post-vaccination)
Results and safety
The study was stopped early (reason given: Sponsor decision. Termination decision not related to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
- VAN00002 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Multicomponent Meningococcal B Vaccine, Meningococcal Group B Vaccine MenB and Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed) in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision. Termination decision not related to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with immediate adverse events (AEs) (time frame: Within 30 minutes after vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.