Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

NCT02842853 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MET43U1111-1161-3060
• Study Type: interventional
• Target: 3,344
• Locations: 1 country
• Sites: 89

Brief Summary

The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US). Primary Objectives:

• To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs).
• To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®. Secondary Objective:
• To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old).
• To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old).
• To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination.
• To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®. Observational Objectives:
• To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine; Licensed MCV4 vaccine

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine

  Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.

  Day 30 (post-vaccination)

• Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

  Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.

  Day 30 (post-vaccination)

Secondary Outcomes (4)

• Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults

  Day 30 (post-vaccination)

• Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents

  Day 30 (post-vaccination)

• Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine

  Day 30 (post-vaccination)

• Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®

  Day 30 (post-vaccination)

Study Arms (4)

MenACYW Conjugate Vaccine Lot 1

EXPERIMENTAL

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1 on Day 0.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

MenACYW Conjugate Vaccine Lot 2

EXPERIMENTAL

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2 on Day 0.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

MenACYW Conjugate Vaccine Lot 3

EXPERIMENTAL

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3 on Day 0.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

Menactra®

ACTIVE COMPARATOR

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.

Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Interventions

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

0.5 mL, Intramuscular

Also known as: MenACYW conjugate vaccine

MenACYW Conjugate Vaccine Lot 1; MenACYW Conjugate Vaccine Lot 2; MenACYW Conjugate Vaccine Lot 3

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra®

Eligibility Criteria

• Age: 10 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Informed consent form was signed and dated by the participant (aged 18 to 55 years) or assent form was signed and dated by the participant and informed consent form was signed and dated by the parent(s) or guardian (for participants aged 10 to \< 18 years).
• Participant (\>= 18 years) or participant (10 to \< 18 years) and parent / guardian were able to attend all scheduled visits and comply with all trial procedures.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must have been pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
• Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
• 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.
• 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 traveling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
• Verbal report of thrombocytopenia, as reported by the participant or the participant's parent / guardian, contraindicating intramuscular vaccination in the Investigator's opinion.
• Personal history of Guillain-Barre syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol abuse or drug addiction.
• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (89)

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Birmingham, Alabama, 35205, United States

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Dothan, Alabama, 36305, United States

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Mobile, Alabama, 36608, United States

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Glendale, Arizona, 85308, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85018, United States

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Harrisburg, Arkansas, 72432, United States

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Jonesboro, Arkansas, 72401, United States

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Anaheim, California, 92804, United States

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Downey, California, 90241, United States

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Los Angeles, California, 90057, United States

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Paramount, California, 90723, United States

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Redding, California, 96001, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92102, United States

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San Diego, California, 92103, United States

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San Diego, California, 96001, United States

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Santa Rosa, California, 95405, United States

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Upland, California, 91786, United States

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West Covina, California, 91790, United States

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Littleton, Colorado, 80128, United States

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DeLand, Florida, 32720, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33016, United States

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Miami, Florida, 33142, United States

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Orlando, Florida, 32806, United States

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Sarasota, Florida, 34239, United States

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South Miami, Florida, 33143, United States

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St. Petersburg, Florida, 33710, United States

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West Palm Beach, Florida, 33409, United States

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Savannah, Georgia, 31406, United States

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Meridian, Idaho, 83642, United States

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Council Bluffs, Iowa, 51503, United States

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Lenexa, Kansas, 66219, United States

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Newton, Kansas, 67114, United States

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Park City, Kansas, 67219, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Bardstown, Kentucky, 40004, United States

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Metairie, Louisiana, 70006, United States

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Bridgeton, Missouri, 63044, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Lincoln, Nebraska, 60505, United States

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Lincoln, Nebraska, 68522, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68134, United States

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Charlotte, North Carolina, 28209, United States

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Raleigh, North Carolina, 27609, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45245, United States

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Cincinnati, Ohio, 45246, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45414, United States

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Dayton, Ohio, 45419, United States

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Corvallis, Oregon, 97330, United States

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Grants Pass, Oregon, 97527, United States

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Erie, Pennsylvania, 16505, United States

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Hermitage, Pennsylvania, 16148, United States

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McMurray, Pennsylvania, 15317, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29414, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Jackson, Tennessee, 38305, United States

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Nashville, Tennessee, 37203, United States

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Tullahoma, Tennessee, 37388, United States

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Corpus Christi, Texas, 78413, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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San Antonio, Texas, 78229, United States

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Waxahachie, Texas, 75165, United States

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Draper, Utah, 84020, United States

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Layton, Utah, 84041, United States

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Murray, Utah, 84123, United States

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Orem, Utah, 84058, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 83642, United States

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West Jordan, Utah, 84088, United States

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Burke, Virginia, 22015, United States

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Charlottesville, Virginia, 22911, United States

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Charlottesville, Virginia, 29902, United States

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Midlothian, Virginia, 23113, United States

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Richmond, Virginia, 23294, United States

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MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur Inc.

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 25, 2016
• Study Start: July 15, 2016
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 5, 2022
• Results First Posted: March 9, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (89)