Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01732627
First received: November 13, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

Primary objectives:

  • To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (SBA-BR), induced by a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135.
  • To describe the safety profile of a single dose of MenACYW conjugate vaccine or Menomune® - A/C/Y/W-135.

Condition Intervention Phase
Meningitis
Meningococcal Meningitis
Meningococcal Infections
Invasive Meningococcal Disease
Biological: MenACYW Conjugate Vaccine
Biological: Meningococcal Polysaccharide Vaccine Groups A, C, Y, W 135 Combined
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentages of Participants with Seroresponse in terms of functional antibodies to the meningococcal serogroups after Vaccination with either MenACYW conjugate or Menomune® Vaccine [ Time Frame: Day 30 post-vaccination ] [ Designated as safety issue: No ]
    Immunogenicity endpoints on serum bactericidal antibody titers for each meningococcal serogroup will be measured by serum bactericidal assay using human and rabbit complements

  • Number of Participants Reporting Solicited Injection Site Reactions, Solicited Systemic Reactions, Unsolicited Systemic Reactions, and Serious Adverse Events Occurring after vaccination with either MenACYW conjugate or Menomune® Vaccine [ Time Frame: Day 0 up to Day 30 post vaccination. ] [ Designated as safety issue: No ]
    Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever (temperature), headache, malaise, and myalgia.


Enrollment: 301
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MenACYW Vaccine Group
Participants who receive MenACYW conjugate vaccine
Biological: MenACYW Conjugate Vaccine
0.5 mL, Intramuscular
Active Comparator: Menomune® A/C/Y/W 135 Vaccine Group
Participants will receive Menomune® A/C/Y/W 135 Vaccine
Biological: Meningococcal Polysaccharide Vaccine Groups A, C, Y, W 135 Combined
0.5 mL, Subcutaneous
Other Name: Menomune® A/C/Y/W 135

Detailed Description:

All participants will receive a single dose of their assigned vaccine on Day 0. They will be assessed for immunogenicity on Day 30, and monitored for safety throughout the study.

  Eligibility

Ages Eligible for Study:   56 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 56 or older on the day of inclusion
  • Informed consent form has been signed and dated
  • Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria:
  • Subject is pregnant, or lactating, or of childbearing potential (to be 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 and until at least 4 weeks after vaccination)
  • Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
  • Previous vaccination against meningococcal disease with either a trial vaccine or another 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
  • Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines 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
  • Self-reported thrombocytopenia, contraindicating intramuscular vaccination
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular 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, is 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°F [≥ 38.0°C]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood draw. Should a subject receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the Investigator will postpone the blood draw until it has been 3 days since the subject last received oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw indicated in the Table of Study Procedures, when possible
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732627

Locations
United States, Arizona
Chandler, Arizona, United States, 85224
Scottsdale, Arizona, United States, 85251
United States, Colorado
Denver, Colorado, United States, 80239
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Missouri
St. Louis, Missouri, United States, 63141
United States, Ohio
Columbus, Ohio, United States, 43212
United States, South Carolina
Anderson, South Carolina, United States, 29621
United States, Utah
Murray, Utah, United States, 84123
Salt Lake City, Utah, United States, 84124
West Jordan, Utah, United States, 84088
United States, Virginia
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01732627     History of Changes
Other Study ID Numbers: MET44, U1111-1127-6804
Study First Received: November 13, 2012
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal Meningitis
Menactra®
Menomune® A/C/Y/W-135

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on August 27, 2014