Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MTA75
Previous Study | Return to List | Next Study

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

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: NCT01239043
Recruitment Status : Completed
First Posted : November 11, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 25, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 8, 2010
First Posted Date  ICMJE November 11, 2010
Results First Submitted Date  ICMJE May 14, 2012
Results First Posted Date  ICMJE June 19, 2012
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2010)
Observational endpoints for safety following re-vaccination with either Menactra® or Menomune® 3 years after initial vaccination. [ Time Frame: Day 0 up to Day 28 post-vaccination ]
Observational safety endpoints will include information on number of immediate reactions, solicited injection site and systemic reactions, all unsolicited adverse events, and serious adverse events following re-vaccination.
Change History Complete list of historical versions of study NCT01239043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2010)
Observational immunogenicity endpoints on serum bactericidal antibody titers for each meningococcal serogroup, measured using both baby rabbit and human complement [ Time Frame: Day 28 post-vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibody Persistence and Response to Re-vaccination With Either Menactra® or Menomune® 3 Years After Initial Vaccination
Official Title  ICMJE 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
Brief Summary

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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Meningitis
  • Meningococcal Infections
Intervention  ICMJE
  • Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
    0.5 mL, Subcutaneous
    Other Name: Menomune®
  • Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
    0.5 mL, Intramuscular
    Other Name: Menactra®
Study Arms  ICMJE
  • Experimental: Menomune® vaccine group
    Participants received Menomune® vaccine in MTA29 (NCT00874549)
    Intervention: Biological: Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide
  • Experimental: Menactra® vaccine group
    Participants received Menactra® vaccine in trial MTA29 (NCT00874549)
    Intervention: Biological: Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 2, 2012)
139
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2010)
160
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 56 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239043
Other Study ID Numbers  ICMJE MTA75
U1111-1115-6685 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP