Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents

NCT04490018 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MEQ000712020-001665-37U1111-1249-2973
• Study Type: interventional
• Target: 463
• Locations: 4 countries
• Sites: 23

Brief Summary

Primary Objective: To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2). Secondary Objective: To describe:

• the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \[adsorbed, reduced antigen(s) content\] (Tdap-IPV) vaccines (Group 3).
• the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.
• the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.
• the safety profile in each group after each and any vaccination.

Conditions

Meningococcal Immunisation; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® Vaccine (Non-inferiority Analysis): Groups 1 and 2

  Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.

  Day 31 (post-vaccination)

Secondary Outcomes (27)

• Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W

  Day 01 (pre-vaccination) and Day 31 (post-vaccination)

• Percentage of Participants With hSBA Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W

  Day 01 (pre-vaccination) and Day 31 (post-vaccination)

• Percentage of Participants With >= 4-Fold Rise In hSBA Antibody Titers Against Meningococcal Serogroups A, C, Y, and W

  From Baseline (Day 01) to Day 31 (post-vaccination)

• Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W

  Day 31 (post-vaccination)

• Geometric Mean Titers (GMTs) of Antibodies Measured by hSBA Against Meningococcal Serogroup C: Meningococcal Serogroup C Conjugate Vaccine (MenC) Primed Participants in Groups 1 and 2

  Day 01 (pre-vaccination) and Day 31 (post-vaccination)

Study Arms (3)

Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)

EXPERIMENTAL

Participants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine); Biological: Human Papillomavirus 9-valent Vaccine (9vHPV); Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)

Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)

ACTIVE COMPARATOR

Participants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.

Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine; Biological: Human Papillomavirus 9-valent Vaccine (9vHPV); Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)

Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)

EXPERIMENTAL

Participants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine); Biological: Human Papillomavirus 9-valent Vaccine (9vHPV); Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)

Interventions

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

Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular

Also known as: MenQuadfi®

Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration); Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)

Meningococcal group A, C, W-135, and Y conjugate vaccine BIOLOGICAL

Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular

Also known as: Nimenrix®

Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)

Human Papillomavirus 9-valent Vaccine (9vHPV) BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Also known as: Gardasil® 9

Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration); Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration); Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV) BIOLOGICAL

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

Also known as: Repevax®/Triaxis®/Adacel®Polio

Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration); Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration); Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than \[\<\] 2 years of age).
• Assent form had been signed and dated by the participant as per local regulation, and Informed Consent Form had been signed and dated by the parent/legally acceptable representative and by the participant if she/he turns 18 years old during the study.
• Participants and parent/legally acceptable representative were able to attend all scheduled visits and compiled with all study procedures.
• Covered by health insurance, if required by local regulations.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.
• Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age.
• Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which might receive at least 2 weeks before study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years.
• Previous human papilloma virus (HPV) vaccination.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• 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 long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
• Personal history of Guillain-Barré syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.
• Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy.
• Verbal report of thrombocytopenia, contraindicating intramuscular vaccination.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (23)

Investigational Site Number :3480003

Budapest, 1042, Hungary

Location

Investigational Site Number :3480001

Győr, 9024, Hungary

Location

Investigational Site Number :3480002

Miskolc, 3527, Hungary

Location

Investigational Site Number :3480004

Szigetvár, 7900, Hungary

Location

Investigational Site Number :3480006

Szombathely, 7900, Hungary

Location

Investigational Site Number :3800005

Foggia, Apulia, 71122, Italy

Location

Investigational Site Number :3800006

Catanzaro, Calabria, 88100, Italy

Location

Investigational Site Number :3800002

Milan, Lombardy, 20154, Italy

Location

Investigational Site Number :3800004

Palermo, Sicily, 90131, Italy

Location

Investigational Site Number :3800001

Genova, IT-16132, Italy

Location

Investigational Site Number :7020002

Singapore, 229899, Singapore

Location

Investigational Site Number :7240001

Seville, Andalusia, 41013, Spain

Location

Investigational Site Number :7240002

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number :7240005

Esplugues de Llobregat, Castille and León, 08950, Spain

Location

Investigational Site Number :7240006

Santiago de Compostela, Galicia [Galicia], 15706, Spain

Location

Investigational Site Number :7240003

Madrid, Madrid, Comunidad de, 28007, Spain

Location

Investigational Site Number :7240011

Burriana, Valenciana, Comunidad, 12530, Spain

Location

Investigational Site Number :7240007

Puçol, Valenciana, Comunidad, 46530, Spain

Location

Investigational Site Number :7240008

Valencia, Valenciana, Comunidad, 46011, Spain

Location

Investigational Site Number :7240004

Valencia, Valenciana, Comunidad, 46020, Spain

Location

Investigational Site Number :7240009

Valencia, Valenciana, Comunidad, 46022, Spain

Location

Investigational Site Number :7240010

Valencia, Valenciana, Comunidad, 46022, Spain

Location

Investigational Site Number :7240012

Valencia, Valenciana, Comunidad, 46024, Spain

Location

Related Publications (1)

• Diez-Domingo J, Simko R, Icardi G, Chong CP, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. Infect Dis Ther. 2024 Aug;13(8):1835-1859. doi: 10.1007/s40121-024-01009-x. Epub 2024 Jul 2.

  PMID: 38955966 DERIVED

Related Links

• MEQ00071 Plain Language Results Summary

MeSH Terms

Interventions

Tetanus Toxoid; Poliovirus Vaccine, Inactivated

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Vaccines, Inactivated; Poliovirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was performed in a partially observer-blind fashion: In Groups 1 and 2 * Investigators and study staff who conducted the safety assessment, participants, parents/legally acceptable representatives, the Sponsor, and laboratory personnel performing the serology testing were kept blinded to the vaccine received. * Only the study staff who prepared and administered the vaccine and were not involved with the safety evaluation know which vaccine was administered. In Group 3 \- Everyone involved in the study (i.e., Investigator, study staff, the Sponsor, participants, parents/legally acceptable representatives) know which vaccine was administered. This open-label design for Group 3 was due to the different vaccination schedule for this group than for Groups 1 and 2.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was a parallel group prevention study with 2 groups that were observer blind (only the person administering the vaccine was unblinded), and 1 group that was open-label.

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 28, 2020
• Study Start: March 16, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: September 12, 2025
• Results First Posted: June 6, 2023

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

SG (1); IT (5); ES (12); HU (5)