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

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ClinicalTrials.gov Identifier: NCT02842866
Recruitment Status : Completed
First Posted : July 25, 2016
Results First Posted : February 18, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

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.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Meningococcal Infections Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined Phase 3

Detailed Description:

Participants were randomized in a 1:1 ratio to receive a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135 on Day 0 (Visit 1).

Participants underwent immunogenicity assessment at baseline (pre-vaccination) and at 30 to 44 days post-vaccination and were also evaluated for safety up to Day 180 post-vaccination.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 907 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults Age 56 Years and Older
Actual Study Start Date : July 15, 2016
Actual Primary Completion Date : February 13, 2017
Actual Study Completion Date : February 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: MenACYW Conjugate Vaccine
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
0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.
Other Name: MenACYW conjugate vaccine

Active Comparator: Group 2: Menomune® Vaccine
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
0.5 mL, Subcutaneous (SC), single dose on Day 0.
Other Name: Menomune® - A/C/Y/W-135




Primary Outcome Measures :
  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 [ Time Frame: Day 30 (Post-vaccination) ]
    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.


Secondary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine [ Time Frame: Day 30 (Post-vaccination) ]
    GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.



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Ages Eligible for Study:   56 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥56 years on the day of inclusion.
  • Informed consent form had been signed and dated.
  • Attended all scheduled visits and complied with all trial procedures.

Exclusion Criteria:

  • 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.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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.
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >=100.4 degree [°] Fahrenheit [F]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
  • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842866


Locations
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United States, Arizona
Chandler, Arizona, United States, 85224
United States, California
Anaheim, California, United States, 92801
San Diego, California, United States, 92103
United States, Connecticut
Waterbury, Connecticut, United States, 06708
United States, Florida
Clearwater, Florida, United States, 33756
DeLand, Florida, United States, 32720
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32216
Ponte Vedra, Florida, United States, 32081
Port Orange, Florida, United States, 32127
West Palm Beach, Florida, United States, 33409
United States, Kansas
Lenexa, Kansas, United States, 66219
Newton, Kansas, United States, 67114
Wichita, Kansas, United States, 67205
United States, Maryland
Elkridge, Maryland, United States, 21075
United States, Massachusetts
Quincy, Massachusetts, United States, 02169
United States, Michigan
Troy, Michigan, United States, 48098
United States, Missouri
Saint Louis, Missouri, United States, 63141
United States, New York
Endwell, New York, United States, 13760
United States, North Carolina
Greensboro, North Carolina, United States, 27408
Raleigh, North Carolina, United States, 27612
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Fargo, North Dakota, United States, 58104
United States, Ohio
Cincinnati, Ohio, United States, 45236
Cincinnati, Ohio, United States, 45246
United States, Oregon
Grants Pass, Oregon, United States, 97527
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18012
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
Mount Pleasant, South Carolina, United States, 29646
United States, Texas
Dallas, Texas, United States, 75231
Dallas, Texas, United States, 75234
United States, Utah
South Jordan, Utah, United States, 84095
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville, Virginia, United States, 22911
Puerto Rico
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
  Study Documents (Full-Text)

Documents provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Study Protocol  [PDF] May 20, 2016
Statistical Analysis Plan  [PDF] July 7, 2016

Publications of Results:
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT02842866    
Other Study ID Numbers: MET49
First Posted: July 25, 2016    Key Record Dates
Results First Posted: February 18, 2020
Last Update Posted: June 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to participant 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. Participant 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW conjugate vaccine
Menomune® - A/C/Y/W-135
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs