Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00269477
First received: December 22, 2005
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.


Condition Intervention Phase
Meningitis
Meningococcal Infection
Biological: Meningococcal 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: Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination. [ Time Frame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination) ] [ Designated as safety issue: No ]

    Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination.

    Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.



Other Outcome Measures:
  • Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions [ Time Frame: Day 0 to 7 post-vaccination ] [ Designated as safety issue: Yes ]
    Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.


Enrollment: 145
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menactra® Vaccine Group 1
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Experimental: Menactra® Vaccine Group 2
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Active Comparator: Meningococcal Vaccine-naive Group 3
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®
Active Comparator: Meningococcal Vaccine-naive Group 4
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra®

  Eligibility

Ages Eligible for Study:   15 Years to 23 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is healthy, as determined by medical history.
  • Subject is between the ages of 15 and 23 years (not yet 24 years).
  • For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine.
  • Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study)
  • Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form.
  • Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications
  • A negative urine pregnancy test is required for menstruating female subjects.

Exclusion Criteria:

  • History of documented invasive meningococcal disease.
  • Received any other meningococcal vaccine
  • Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment
  • Scheduled to receive any vaccination in the 28-day period after enrollment
  • Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample
  • Actively enrolled or scheduled to be enrolled in another clinical study
  • Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system)
  • Known or suspected impairment of immunologic function
  • Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion
  • Administration of immune globulin, other blood products, or corticosteroid within 3 months 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.
  • Personal or family history of Guillain-Barre Syndrome
  • Suspected or known hypersensitivity to any of the vaccine components
  • Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
  • Any condition, which in the opinion of the investigator would pose a health risk to the participant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269477

Locations
United States, Georgia
Atlanta, Georgia, United States, 30322
Marietta, Georgia, United States, 30062
United States, Massachusetts
Woburn, Massachusetts, United States, 01801
United States, Ohio
Akron, Ohio, United States, 44308
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Sellersville, Pennsylvania, United States, 18960
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Virginia
Norfolk, Virginia, United States, 23510
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: NCT00269477     History of Changes
Other Study ID Numbers: MTA35
Study First Received: December 22, 2005
Results First Received: November 10, 2009
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Meningitis
Meningococcal infection
Neisseria meningitidis
Menactra®
Menomune®

Additional relevant MeSH terms:
Infection
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014