Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01239043
First received: November 8, 2010
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

The purpose of this trial is to describe antibody persistence and response to re-vaccination with either Menactra® or Menomune® vaccine approximately three years following initial vaccination in adults who participated in trial MTA29 (NCT00874549).

Objectives:

  • To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination.
  • To evaluate persistence of serum bactericidal antibodies in subjects who received Menactra® or Menomune® vaccine approximately three years ago.
  • To evaluate the immune response to serogroups A, C, Y, and W-135 in subjects re-vaccinated with either Menactra® or Menomune® vaccine.

Condition Intervention Phase
Meningitis
Meningococcal Meningitis
Meningococcal Infections
Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® Vaccine Approximately Three Years Following Initial Vaccination in Adults Who Participated in Trial MTA29

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Either Menomune or Menactra Vaccine [ Time Frame: Day 0 to Day 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia.

    Grade 3 reactions were defined as: Pain, headache, malaise, and myalgia - significant, prevents daily activity; Erythema and swelling - > 100 mm; Fever, temperature of ≥ 39.0ºC or ≥ 102.1ºF.



Enrollment: 139
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menomune® vaccine group
Participants received Menomune® vaccine in MTA29 (NCT00874549)
Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
0.5 mL, Subcutaneous
Other Name: Menomune®
Experimental: Menactra® vaccine group
Participants received Menactra® vaccine in trial MTA29 (NCT00874549)
Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®

Detailed Description:

Participants who were randomized and received either Menactra® or Menomune® vaccine in trial MTA29 will receive 1 dose of either Menactra® or Menomune®, respectively on Day 0 and will be followed-up for 28 days post-vaccination.

  Eligibility

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

Inclusion Criteria:

  • Aged 56 years or older on the day of inclusion.
  • Received the appropriate Menactra or Menomune vaccine as assigned by randomization in Trial MTA29.
  • Ambulatory and healthy, as determined by medical history.
  • Informed consent form has been signed and dated.
  • Able to attend all scheduled visits and to comply with all trial procedures.
  • For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

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.
  • Known pregnancy, or a positive pregnancy test.
  • Currently breastfeeding a child.
  • History of documented invasive meningococcal disease.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Receipt of any meningococcal vaccine since participation in trial MTA29.
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
  • Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
  • 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).
  • Laboratory-confirmed seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C.
  • Previous personal history of Guillain-Barré Syndrome (GBS).
  • Known systemic hypersensitivity to any of the vaccine components, latex, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
  • Laboratory-confirmed thrombocytopenia, contraindicating intramuscular (IM) vaccination.
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
  • Current alcohol or drug use that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.
  • Not available for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
  • Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
  • Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01239043

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 Jordan, Utah, United States, 84088
United States, Washington
Seattle, Washington, United States, 98101
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01239043     History of Changes
Other Study ID Numbers: MTA75, U1111-1115-6685
Study First Received: November 8, 2010
Results First Received: May 14, 2012
Last Updated: June 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal Meningitis
Meningococcal Infections
Menactra®
Menomune®
Meningococcal vaccine

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
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014