Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

NCT02842866 | Completed Phase 3 Results FDA Drug

• 1 other identifier: MET49
• Study Type: interventional
• Target: 907
• Locations: 2 countries
• Sites: 36

Brief Summary

The aim of the study was to demonstrate non-inferiority of immunogenicity and evaluate the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid conjugate vaccine (MenACYW conjugate vaccine) compared to a single dose of Meningococcal Polysaccharide Vaccine Serogroups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in adults 56 years of age and older in the United States. Primary objective:

• To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to those observed following the administration of a single dose of Menomune® - A/C/Y/W-135. Secondary objective:
• To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of Menomune® - A/C/Y/W-135. Observational objectives:
• To describe antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (before vaccination) and 30 days after vaccination with MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 in a subset of 100 participants per treatment group.
• To describe the safety profile of MenACYW conjugate vaccine compared to that of the licensed Menomune® - A/C/Y/W-135 after a single administration.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW conjugate vaccine; Menomune® - A/C/Y/W-135

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine

  Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 for participants with pre-vaccination hSBA titers less than (\<) 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 (1)

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

  Day 30 (Post-vaccination)

Study Arms (2)

Group 1: MenACYW Conjugate Vaccine

EXPERIMENTAL

Healthy, adult participants aged greater than or equal to (≥) 56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.

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

Group 2: Menomune® Vaccine

ACTIVE COMPARATOR

Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.

Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined

Interventions

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

0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.

Also known as: MenACYW conjugate vaccine

Group 1: MenACYW Conjugate Vaccine

Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined BIOLOGICAL

0.5 mL, Subcutaneous (SC), single dose on Day 0.

Also known as: Menomune® - A/C/Y/W-135

Group 2: Menomune® Vaccine

Eligibility Criteria

• Age: 56 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form had been signed and dated.
• Attended all scheduled visits and complied with all trial procedures.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be 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) preceded the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after study vaccine. This exception included 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 travelling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to latex or any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial 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.
• Verbal report of thrombocytopenia, contraindicating IM vaccination, in the Investigator's opinion.
• 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 (36)

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Chandler, Arizona, 85224, United States

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Anaheim, California, 92801, United States

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San Diego, California, 92103, United States

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Waterbury, Connecticut, 06708, United States

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Clearwater, Florida, 33756, United States

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DeLand, Florida, 32720, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Ponte Vedra, Florida, 32081, United States

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Port Orange, Florida, 32127, United States

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West Palm Beach, Florida, 33409, United States

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Lenexa, Kansas, 66219, United States

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Newton, Kansas, 67114, United States

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Wichita, Kansas, 67205, United States

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Elkridge, Maryland, 21075, United States

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Quincy, Massachusetts, 02169, United States

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Troy, Michigan, 48098, United States

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St Louis, Missouri, 63141, United States

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Endwell, New York, 13760, United States

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Greensboro, North Carolina, 27408, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45236, United States

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Cincinnati, Ohio, 45246, United States

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Grants Pass, Oregon, 97527, United States

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Allentown, Pennsylvania, 18012, United States

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Uniontown, Pennsylvania, 15401, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Mt. Pleasant, South Carolina, 29646, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75234, United States

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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 84088, United States

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Charlottesville, Virginia, 22911, United States

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San Juan, 00918, Puerto Rico

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Related Publications (1)

• Esteves-Jaramillo A, Koehler T, Jeanfreau R, Neveu D, Jordanov E, Singh Dhingra M. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in >/=56-year-olds: A Phase III randomized study. Vaccine. 2020 Jun 9;38(28):4405-4411. doi: 10.1016/j.vaccine.2020.04.067. Epub 2020 May 6.

  PMID: 32387012 RESULT

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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 13, 2017
• Study Completion: February 13, 2017
• Last Updated: April 5, 2022
• Results First Posted: February 18, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (35)