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Trial record 1 of 1 for:    MTA29
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Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874549
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : March 25, 2010
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

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 or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
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®


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

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

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


Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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
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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): NCT00874549


Locations
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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
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Study Director: Medical Monitor Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00874549    
Other Study ID Numbers: MTA29
First Posted: April 2, 2009    Key Record Dates
Results First Posted: March 25, 2010
Last Update Posted: September 20, 2013
Last Verified: September 2013
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningococcal Vaccine
Menactra®
Menomune®
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Neuroinflammatory Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Central Nervous System Diseases