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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1272-6824 | Registry Identifier | ICTRP | |
| 2023-000924-13 | EudraCT Number |
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The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.
The study duration will be up to 12 months for all participants.
The study duration will be approximately 12 months for all participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MenPenta Formulation 1 | Experimental | Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo |
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| Group 2: MenPenta Formulation 2 | Experimental | Participants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo |
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| Group 3: Bexsero® + Menveo® | Active Comparator | Participants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine |
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| Group 4: Trumenba® + Menveo® | Active Comparator | Participants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine |
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| Group 5: MenQuadfi® | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pentavalent Meningococcal ABCYW vaccine | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes after each vaccination |
| Number of participants with solicited injection site reactions or systemic reactions | Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF | Within 7 days after each vaccination |
| Number of participants with unsolicited AEs | Non-serious AEs other than solicited reactions | Within 30 days after each vaccination |
| Number of participants with serious adverse events (SAEs) | SAEs (including adverse events of special interest [AESIs]) reported throughout the study | From baseline up to 12 months |
| Number of participants with medically attended adverse events (MAAEs) | An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department | From baseline up to 12 months |
| Number of participants with out-of-range biological test results | Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group | |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants |
| Measure | Description | Time Frame |
|---|---|---|
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint | Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers < 1:4 or post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with pre-dose 1 vaccination titers more than the lower limit of quantification (LLOQ) | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
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Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080 | Birmingham | Alabama | 35216 | United States | ||
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| Label | URL |
|---|---|
| VAN00010 Plain Language Results Summary | View source |
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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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Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit
Participants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
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| Group 6: Sanofi MenB | Experimental | Participants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo |
|
| Group 7: PENBRAYA | Active Comparator | Participants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo |
|
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| MenACYW conjugate vaccine | Biological | Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM) |
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| Meningococcal group B vaccine | Biological | Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM) |
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| Meningococcal group B vaccine | Biological | Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM) |
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| Meningococcal group B vaccine | Biological | Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM) |
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| MenACYW conjugate vaccine | Biological | Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM) |
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| Placebo | Biological | Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM) |
|
| MenABCYW conjugate vaccine | Biological | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM) |
|
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Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ) |
| Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants | hSBA titers ≥ 1:8 | Day 211 (for Group 1 to 7) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants | Geometric mean titers | Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7) |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants | Day 01 (pre-dose) Day 211 (for Group 1 to 7) |
| hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants | Seroresponse defined as a 4-fold increase in hSBA titers | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants | hSBA titers ≥ 1:4 for reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants | hSBA titers ≥ 1:8 for reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants | Geometric mean titers for the reference MenB strains | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 7) |
| hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint | hSBA titers ≥ 1:8 post-vaccination | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint | Geometric mean titers | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint | Seroresponse defined as a 4-fold increase in hSBA titers | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint | hSBA titers ≥ 1:4 for reference MenB strains | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint | hSBA titers ≥ 1:8 reference MenB strains | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint | Geometric mean titers for reference MenB strains | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint | D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7) |
| hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants | Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants | hSBA titers ≥ 1:4 for reference and additional MenB strains | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants | hSBA titers ≥ 1:8 for reference and additional MenB strains | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants | Geometric mean titers for reference and additional MenB strains | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) |
| Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants | Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents) |
| hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants | Seroresponse defined as post-third vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post-third vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than the lower limit of quantification (LLOQ) | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants | Day 01 (pre-dose) and Day 211 (for Group 1 to 6) |
| Lakeview Clinical Research Site Number : 8400029 |
| Guntersville |
| Alabama |
| 35976-2206 |
| United States |
| Alliance for Multispecialty Research- Phoenix- Site Number : 8400056 | Tempe | Arizona | 85281 | United States |
| Harrisburg Family Medical Center Site Number : 8400070 | Harrisburg | Arkansas | 72432 | United States |
| Smart Cures Clinical Research Site Number : 8400072 | Anaheim | California | 92806 | United States |
| Hope Clinical Research, LLC- Site Number : 8400001 | Canoga Park | California | 91303 | United States |
| Apex Research Group Site Number : 8400071 | Fair Oaks | California | 95628 | United States |
| Velocity Clinical Research-Washington DC Site Number : 8400102 | Washington D.C. | District of Columbia | 20016 | United States |
| Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081 | DeLand | Florida | 32720-0834 | United States |
| SIMEDHealth, LLC- Site Number : 8400045 | Gainesville | Florida | 32607 | United States |
| Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082 | Largo | Florida | 33777 | United States |
| South Florida Research Organization Site Number : 8400086 | Medley | Florida | 33166 | United States |
| Life Arc Research-Miami Site Number : 8400094 | Miami | Florida | 33126 | United States |
| Charisma Medical and Research center Site Number : 8400097 | Miami Lakes | Florida | 33014 | United States |
| Accel Research - Nona Pediatric Center Site Number : 8400079 | Orlando | Florida | 32829 | United States |
| Ormond Beach Clinical Research- Site Number : 8400073 | Ormond Beach | Florida | 32174 | United States |
| Palm Harbor Dermatology- Site Number : 8400030 | Tampa | Florida | 33609 | United States |
| PAS Research Site Number : 8400032 | Tampa | Florida | 33613 | United States |
| VICIS Clinical Research-Tampa Site Number : 8400065 | Tampa | Florida | 33614 | United States |
| Leavitt Clinical Research-Idaho Falls- Site Number : 8400075 | Idaho Falls | Idaho | 83404 | United States |
| Snake River Research, PLLC- Site Number : 8400100 | Idaho Falls | Idaho | 83404 | United States |
| AES Peoria- Site Number : 8400090 | Peoria | Illinois | 61614 | United States |
| AMR Evansville Site Number : 8400062 | Evansville | Indiana | 47712 | United States |
| AMR - Newton- Site Number : 8400104 | Newton | Kansas | 67114 | United States |
| ~Kentucky Pediatics / Adult Research- Site Number : 8400009 | Bardstown | Kentucky | 40004 | United States |
| Michael W. Simon, MD, PSC- Site Number : 8400026 | Lexington | Kentucky | 40517 | United States |
| Vida Clinical Studies Site Number : 8400084 | Dearborn Heights | Michigan | 48127-2234 | United States |
| Vida Clinical Studies- Site Number : 8400084 | Dearborn Heights | Michigan | 48127-2234 | United States |
| Be Well Clinical Studies- Site Number : 8400077 | Lincoln | Nebraska | 68516 | United States |
| Alivation Research (Primary Care) Site Number : 8400046 | Lincoln | Nebraska | 68526 | United States |
| Quality Clinical Research, Inc.- Site Number : 8400074 | Omaha | Nebraska | 68114 | United States |
| Velocity Clinical Research, Omaha- Site Number : 8400066 | Omaha | Nebraska | 68134 | United States |
| Velocity Clinical Research-Albuquerque- Site Number : 8400101 | Albuquerque | New Mexico | 87107 | United States |
| Prime Global Research, Inc. Site Number : 8400043 | The Bronx | New York | 10456 | United States |
| Monroe Biomedical Research - Site Number : 8400099 | Monroe | North Carolina | 28112 | United States |
| SPICA Clinical Research Site Number : 8400098 | Columbia | South Carolina | 29223 | United States |
| Coastal Carolina Research Center - N Charleston- Site Number : 8400050 | North Charleston | South Carolina | 29405 | United States |
| Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049 | Simpsonville | South Carolina | 29681 | United States |
| Pediatric Clinical Trials Tullahoma- Site Number : 8400020 | Tullahoma | Tennessee | 37388 | United States |
| New Horizon Medical Group-Houston Site Number : 8400069 | Houston | Texas | 77063 | United States |
| DM Clinical Research- Bellaire- Site Number : 8400052 | Houston | Texas | 77081 | United States |
| Advances in Health- Pearland- Site Number : 8400078 | Pearland | Texas | 77584 | United States |
| Be Well Clinical Studies -Round Rock Site Number : 8400053 | Round Rock | Texas | 78681 | United States |
| Progressive Clinical Research- Site Number : 8400028 | Bountiful | Utah | 84010 | United States |
| AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106 | Kaysville | Utah | 84037 | United States |
| Alliance for Multispecialty Research- Site Number : 8400107 | Murray | Utah | 84107 | United States |
| Investigational Site Number : 6300001 | San Juan | 00918 | Puerto Rico |
| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
| C000729870 | MenB-FHbp vaccine |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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