Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

Healthy Volunteers Clinical Trial

Official title:

A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128733
• Other study ID #: VAN00010
• Secondary ID: U1111-1272-68242
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 31, 2023
• Est. completion date: May 21, 2025

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study duration will be approximately 12 months for all participants

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1220
• Est. completion date: May 21, 2025
• Est. primary completion date: May 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.

• Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

• Known or suspected congenital or acquired immunodeficiency

• History of any Neisseria meningitidis infection

• At high risk for meningococcal infection during the study

• Individuals with active tuberculosis

• History of Guillain-Barré syndrome

• Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Healthy Volunteers
• Meningococcal Immunisation
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Pentavalent Meningococcal ABCYW vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
• MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
• Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
• Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)
• Meningococcal group B vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)
• MenACYW conjugate vaccine
Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)
• Placebo
Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)
• MenABCYW conjugate vaccine
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Locations

Country	Name	City	State
Puerto Rico	Investigational Site Number : 6300001	San Juan
United States	Velocity Clinical Research-Albuquerque Site Number : 8400101	Albuquerque	New Mexico
United States	Smart Cures Clinical Research Site Number : 8400072	Anaheim	California
United States	~Kentucky Pediatics / Adult Research Site Number : 8400009	Bardstown	Kentucky
United States	Accel Research Site - Birmingham Clinical Research Unit Site Number : 8400080	Birmingham	Alabama
United States	Progressive Clinical Research Site Number : 8400028	Bountiful	Utah
United States	Prime Global Research, Inc. Site Number : 8400043	Bronx	New York
United States	Hope Clinical Research, LLC Site Number : 8400001	Canoga Park	California
United States	SPICA Clinical Research Site Number : 8400098	Columbia	South Carolina
United States	Life Arc Research Site Number : 8400094	Coral Gables	Florida
United States	Vida Clinical Studies Site Number : 8400084	Dearborn Heights	Michigan
United States	Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400081	DeLand	Florida
United States	AMR Evansville Site Number : 8400062	Evansville	Indiana
United States	Apex Research Group Site Number : 8400071	Fair Oaks	California
United States	SIMEDHealth, LLC Site Number : 8400045	Gainesville	Florida
United States	Lakeview Clinical Research Site Number : 8400029	Guntersville	Alabama
United States	Harrisburg Family Medical Center Site Number : 8400070	Harrisburg	Arkansas
United States	DM Clinical Research- Bellaire Site Number : 8400052	Houston	Texas
United States	New Horizon Medical Group-Houston Site Number : 8400069	Houston	Texas
United States	Leavitt Clinical Research-Idaho Falls Site Number : 8400075	Idaho Falls	Idaho
United States	Snake River Research, PLLC Site Number : 8400100	Idaho Falls	Idaho
United States	AMR Utah-Wee Care Pediatrics-Kaysville Site Number : 8400106	Kaysville	Utah
United States	Accel Research Sites-St. Petersburg-Largo Site Number : 8400082	Largo	Florida
United States	Michael W. Simon, MD, PSC Site Number : 8400026	Lexington	Kentucky
United States	Alivation Research (Primary Care) Site Number : 8400046	Lincoln	Nebraska
United States	Be Well Clinical Studies Site Number : 8400077	Lincoln	Nebraska
United States	South Florida Research Organization Site Number : 8400086	Medley	Florida
United States	Charisma Medical and Research center Site Number : 8400097	Miami Lakes	Florida
United States	Monroe Biomedical Research Site Number : 8400099	Monroe	North Carolina
United States	AMR-Cottonwood Pediatrics Site Number : 8400107	Murray	Utah
United States	AMR - Newton Site Number : 8400104	Newton	Kansas
United States	Coastal Carolina Research Center - N Charleston Site Number : 8400050	North Charleston	South Carolina
United States	Quality Clinical Research, Inc. Site Number : 8400074	Omaha	Nebraska
United States	Velocity Clinical Research, Omaha Site Number : 8400066	Omaha	Nebraska
United States	Accel Research - Nona Pediatric Center Site Number : 8400079	Orlando	Florida
United States	Ormond Beach Clinical Research Site Number : 8400073	Ormond Beach	Florida
United States	Advances in Health- Pearland Site Number : 8400078	Pearland	Texas
United States	AES Peoria Site Number : 8400090	Peoria	Illinois
United States	Be Well Clinical Studies -Round Rock Site Number : 8400053	Round Rock	Texas
United States	Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049	Simpsonville	South Carolina
United States	Palm Harbor Dermatology Site Number : 8400030	Tampa	Florida
United States	PAS Research Site Number : 8400032	Tampa	Florida
United States	VICIS Clinical Research-Tampa Site Number : 8400065	Tampa	Florida
United States	Alliance for Multispecialty Research- Phoenix Site Number : 8400056	Tempe	Arizona
United States	Pediatric Clinical Trials Tullahoma Site Number : 8400020	Tullahoma	Tennessee
United States	Velocity Clinical Research-Washington DC Site Number : 8400102	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with immediate adverse events (AEs)	Unsolicited systemic AEs that occur within 30 minutes after vaccination	Within 30 minutes after each vaccination
Primary	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
Primary	Number of participants with unsolicited AEs	AEs other than solicited reactions	Within 30 days after each vaccination
Primary	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
Primary	Number of participants with medically attended adverse events (MAAEs)		From baseline up to 12 months
Primary	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
Primary	hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the last dose in adolescent participants	Seroresponse defined as post-vaccination titers = 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post vaccination titers = 4 times the pre-vaccination titer for participants with a prevaccination titer more than or equal to the lower limit of quantification (LLOQ)	Day 01 (pre-dose) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, 5 and 7)
Primary	hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the last dose in adolescent participants	hSBA titers = 1:8 post-vaccination (post-last dose)	Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, 5 and 7)
Primary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adolescent participants	Geometric mean titers (pre-dose and post-last dose)	Day 01 (pre-dose) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, 5 and 7)
Primary	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) and Day 31 (for Group 3 and 4) or Day 211 (for Group 1, 2, 5 and 7)
Primary	hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after last dose in adolescent participants	Seroresponse defined as a 4-fold increase in hSBA titers	Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, 6 and 7)
Primary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) = 1:4 pre-dose 1 and 1 month post-last dose in adolescent participants	hSBA titers = 1:4 for reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, 6 and 7)
Primary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) = 1:8 pre-dose 1 and 1 month post-last dose in adolescent participants	hSBA titers = 1:8 for reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, 6 and 7)
Primary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants	Geometric mean titers (pre-dose and post-last dose) for the reference MenB strains	Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, 4, 6 and 7)
Primary	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, 2, 3, 4, 6 and 7)
Primary	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
Secondary	hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint	Seroresponse defined as post-vaccination hSBA titers = 1:16 for participants with pre-vaccination hSBA titers < 1:4 or post-vaccination titer = 4 times the pre-vaccination titer for participants with pre-vaccination hSBA titers more than the lower limit of quantification (LLOQ)	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5 and Group 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1 to 5 and Group 7)
Secondary	hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint	hSBA titers = 1:8 post-vaccination (post-last dose)	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5 and Group 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1 to 5 and Group 7)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint	Geometric mean titers (pre-dose and post-last dose)	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5 and Group 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1 to 5 and Group 7)
Secondary	Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint		Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1 to 5 and Group 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1 to 5 and Group 7)
Secondary	hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint	Seroresponse defined as a 4-fold increase in hSBA titers	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, 6 and 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, 6 and 7)
Secondary	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	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, 6 and 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, 6 and 7)
Secondary	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	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, 6 and 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, 6 and 7)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint	Geometric mean titers (pre-dose and post-last dose) for reference MenB strains	Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, 6 and 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, 6 and 7)
Secondary	Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint		Day 01 and Day 31, Day 61, Day 181 and Day 211 for adult participants (for Group 1, 2, 3, 4, 6 and 7) Day 01 and Day 31, Day 181 and Day 211 for adolescent participants (for Group 1, 2, 3, 4, 6 and 7)
Secondary	hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-last dose in adolescent participants	Seroresponse defined as a 4-fold increase in hSBA titers from D01 (pre-dose 1 administration) to post-vaccination (D211) for the additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) = 1:4 pre-dose 1 and 1 month post-last dose in adolescent participants	hSBA titers = 1:4 for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) = 1:8 pre-dose 1 and 1 month post-last dose in adolescent participants	hSBA titers = 1:8 for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adolescent participants	Geometric mean titers (pre-dose and post-last dose) for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6)
Secondary	Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ additional MenB strains in adolescent participants		Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 3, 4, and 6)
Secondary	hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the last dose in adult participants	Seroresponse defined as post-vaccination titers = 1:16 for participants with pre-vaccination hSBA titers < 1:4 or = 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, 2 and 5) or Day 31 (for Group 3, 4 and 5)
Secondary	hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2 and 5) or Day 31 (for Group 3, 4 and 5)
Secondary	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, 2 and 5) or Day 31 (for Group 3, 4 and 5)
Secondary	hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) = 1:4 pre-dose 1 and 1 month post-last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) = 1:8 pre-dose 1 and 1 month post-last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-last dose in adult participants		Day 01 (pre-dose) and Day 211 (for Group 1, 2, 3, and 6) or Day 61 (for Group 3)
Secondary	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, 2, 3, and 6) or Day 61 (for Group 3)
Secondary	hSBA meningococcal serogroup B (additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-last dose in adults and adolescent participants	Seroresponse defined as a 4-fold increase in hSBA titers from D01 (pre-dose 1 administration) to post-vaccination (D211) for the additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 4 and 6 or Day 61 for Group 3 for adults) and Day 211 (for Group 1, 2, 3, 4, 6 and 7 for adolescents)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) = 1:4 pre-dose 1 and 1 month post-last dose in adults and adolescent participants	hSBA titers = 1:4 for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 4 and 6 or Day 61 for Group 3 for adults) and Day 211 (for Group 1, 2, 3, 4, 6 and 7 for adolescents)
Secondary	Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (additional MenB strains) = 1:8 pre-dose 1 and 1 month post-last dose in adults and adolescent participants	hSBA titers = 1:8 for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 4 and 6 or Day 61 for Group 3 for adults) and Day 211 (for Group 1, 2, 3, 4, 6 and 7 for adolescents)
Secondary	Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (additional MenB strains) pre-dose 1 and 1 month post-last dose in adults and adolescent participants	Geometric mean titers (pre-dose and post-last dose) for additional MenB strains	Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 4 and 6 or Day 61 for Group 3 for adults) and Day 211 (for Group 1, 2, 3, 4, 6 and 7 for adolescents)
Secondary	Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ additional MenB strains in adults and adolescent participants		Day 01 (pre-dose) and Day 211 (post-dose 2) (for Group 1, 2, 4 and 6 or Day 61 for Group 3 for adults) and Day 211 (for Group 1, 2, 3, 4, 6 and 7 for adolescents)