Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00874549
First received: March 31, 2009
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

Safety:

To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune® vaccine.

Immunogenicity:

To evaluate the immune response to serogroups A, C, Y, and W-135 in each of the four study groups.


Condition Intervention Phase
Meningococcal Infections
Meningococcal Meningitis
Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
Phase 1
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: A Safety and Immunogenicity Evaluation of a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) and a Meningococcal Polysaccharide Vaccine Groups A, C, Y, and W-135 Combined (Menomune® - A/C/Y/W-135) in Subjects 56 Years of Age or Older

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-Vaccination 1. [ Time Frame: 0-7 days post-vaccination 1 ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.

  • Number of Participants With At Least One Solicited Injection Site Reaction Post-Vaccination 2 [ Time Frame: 0-7 Days Post-vaccination 2 ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Pain, Erythema, and Swelling.

  • Number of Participants With At Least One Solicited Systemic Reaction Post-Vaccination 2 [ Time Frame: Day 0 to 7 Post-vaccination 2 ] [ Designated as safety issue: Yes ]
    Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, chills, Arthralgia, Urticaria, Anorexia, Diarrhea, and Vomiting.


Other Outcome Measures:
  • Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 1. [ Time Frame: Day 28 Post-vaccination 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Antibody Titers Using Baby Rabbit Complement (SBA-BR) Post-Vaccination 2 [ Time Frame: Day 28 Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre- and Post-vaccination 1 [ Time Frame: Day 0 and Day 28 Post-vaccination 1 ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) of Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Pre-vaccination 1 and Post-vaccination 2 [ Time Frame: Day 0 and 28 days Post-vaccination 2 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8) Pre- and Post-vaccination 1 [ Time Frame: Day 28 Post-vaccination 1 ] [ Designated as safety issue: No ]
  • Percentage of Participants Achieving Serum Bactericidal Antibody Using Baby Rabbit Complement (SBA-BR) Titers of at Least 1:8 (≥1:8), Pre-vaccination 1 and Post-vaccination 2 [ Time Frame: Day 0 and Day 28 Post-vaccination 2 ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: Menomune Day 0
Participants received a single dose of Menomune® vaccine on Day 0.
Biological: Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
Other Name: Menomune®
Experimental: Group 2: Menactra® Day 0 x 2
Participants received two single-dose injections of Menactra® vaccine on Day 0
Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Group 3: Menactra® Day 0 and 14
Participants received a single dose of Menactra® vaccine on Day 0 and on Day 14
Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL. Intramuscular
Other Name: Menactra®
Experimental: Group 4: Menactra® Day 0 and 28
Participants received a single dose of Menactra® vaccine on Day 0 and on Day 28.
Biological: Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®

  Eligibility

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

Inclusion Criteria:

  • Ambulatory and healthy, as determined by medical history.
  • 56 years of age or older at the time of vaccination.
  • Signed Institutional Review Board (IRB)-approved informed consent form.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a woman, inability to become pregnant or a negative urine pregnancy test at the time of enrollment.

Exclusion Criteria:

  • Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
  • Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc) that is unstable or that might 1) interfere with the ability to participate fully in the study or 2) interfere with evaluation of the vaccines.
  • Known or suspected impairment of immunologic function.
  • Febrile illness within the last 72 hours or an oral temperature ≥ 100.4ºF at the time of inclusion.
  • History of documented invasive meningococcal disease or previous meningococcal vaccination.
  • Known or suspected receipt of a diphtheria-containing vaccine within the preceding 2 years.
  • Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulator therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment.
  • Systemic antibiotic therapy within the 72 hours prior to collection of any blood samples.
  • Received any vaccine in the 28-day period prior to enrollment or scheduled to receive any vaccination through Visit 2 for Groups 1 and 2 and through Visit 3 for Groups 3 and 4. Influenza vaccines may be received 2 weeks before or after a study vaccination.
  • Suspected or known hypersensitivity to latex or to any of the components of either Menactra® vaccine or Menomune® vaccine.
  • Previous personal history of Guillain-Barré syndrome.
  • Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
  • In females of childbearing potential, a positive or equivocal urine pregnancy test at enrollment.
  • A nursing mother.
  • Participation in another interventional clinical trial in the 4 weeks preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study.
  • Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial visits or procedures.
  • Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874549

Locations
United States, Arizona
Scottsdale, Arizona, United States, 85251
United States, Kentucky
Bardstown, Kentucky, United States, 40004
United States, New Mexico
Albuquerque, New Mexico, United States, 87108
United States, Utah
West Jordon, Utah, United States, 84088
United States, Washington
Seattle, Washington, United States, 98101
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00874549     History of Changes
Other Study ID Numbers: MTA29
Study First Received: March 31, 2009
Results First Received: March 8, 2010
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningococcal Vaccine
Menactra®
Menomune®

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 April 17, 2014