Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MTA64
Previous Study | Return to List | Next Study

Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

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: NCT00862277
Recruitment Status : Completed
First Posted : March 16, 2009
Results First Posted : January 13, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date March 13, 2009
First Posted Date March 16, 2009
Results First Submitted Date December 11, 2010
Results First Posted Date January 13, 2011
Last Update Posted Date April 14, 2016
Study Start Date December 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2011)
  • Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment [ Time Frame: Day 0 ]
  • Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment [ Time Frame: Day 0 ]
Original Primary Outcome Measures
 (submitted: March 13, 2009)
To provide information concerning the immunogenicity of Menactra® [ Time Frame: Clinic Visit Day 1 (4-8 years post-vaccination) ]
Change History Complete list of historical versions of study NCT00862277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine
Official Title Evaluation of the Persistence of Bactericidal Antibodies in Adolescents and Adults Who Received a Single Dose of Menactra® Four to Eight Years Earlier
Brief Summary To evaluate the persistence of bactericidal antibodies in adolescents and adults who received one dose of Menactra® vaccine approximately four to eight years earlier
Detailed Description

Subjects who received one dose of Menactra® or Menomune® in study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257) will be eligible for enrollment in trial this study. All eligible subjects will provide a blood sample at Visit 1, after which their participation in the study will be terminated. An age-matched meningococcal-vaccine naïve control group will be recruited to provide a blood sample for baseline antibody level evaluation.

No vaccine will be administered in this study.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects that previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19 (NCT00777790), or MTA21 (NCT00777257); or Menomune® in Study MTA04 and age-matched meningococcal vaccine-naive controls.
Condition
  • Meningococcal Infections
  • Meningitis
Intervention
  • Biological: Menactra®
    0.5 mL, Intramuscular (from a previous study)
  • Biological: Menomune®
    0.5 mL, Intramuscular (from a previous study)
Study Groups/Cohorts
  • Group 1: Menactra® from Previous Studies
    Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.
    Intervention: Biological: Menactra®
  • Group 2: Menomune® from Previous Study
    Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
    Intervention: Biological: Menomune®
  • Group 3: Control
    Meningococcal vaccine-naive age matched subjects
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 Completed
Actual Enrollment
 (submitted: February 22, 2010)
763
Original Estimated Enrollment
 (submitted: March 13, 2009)
600
Actual Study Completion Date December 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria :

  • For subjects aged ≥ 18 years: Informed consent form signed and dated by the subject
  • For subjects aged < 18 years: Informed consent form signed and dated by the subject and the subject's parent/legal guardian
  • Subject (and parent/legal guardian if subject is < 18 years of age) able to attend the scheduled visit and comply with all trial procedures
  • For Group 1: Previously received only one dose of meningococcal vaccine (Menactra®, received in Study MTA04, MTA12, MTA19, or MTA21)
  • For Group 2: Previously received only one dose of meningococcal vaccine (Menomune®, received in Study MTA04)
  • For Group 3: Aged 14 through 27 years and never received any meningococcal vaccine

Exclusion Criteria :

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding inclusion
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy > 2 weeks
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune responses
  • Known Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C seropositivity
  • History of invasive meningococcal disease (confirmed either clinically, serologically, or microbiologically)
  • For Groups 1 and 2: Previous vaccination (including booster) against meningococcal disease, with the exception of the Menactra® or Menomune® vaccination received in trial MTA04, MTA12, MTA19, or MTA21
  • Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Received oral or injected antibiotic therapy within the 72 hours prior to the blood draw (temporary criteria)
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years to 27 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00862277
Other Study ID Numbers MTA64
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor Sanofi Pasteur, a Sanofi Company
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2016