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

• ClinicalTrials.gov Identifier: NCT00269477
• Recruitment Status: Completed
• First Posted: December 23, 2005
• Results First Posted: December 14, 2009
• Last Update Posted: April 14, 2016
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Meningitis; Meningococcal Infection	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 145 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: December 2005
• Actual Primary Completion Date: February 2007
• Actual Study Completion Date: December 2007

Arms and Interventions

Arm	Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :

1. 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) ]

   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:

1. Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions [ Time Frame: Day 0 to 7 post-vaccination ]
   Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 23 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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:

Related Info 

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00269477
• Other Study ID Numbers: MTA35
• First Posted: December 23, 2005
• Results First Posted: December 14, 2009
• Last Update Posted: April 14, 2016
• Last Verified: April 2016

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

Meningitis; Meningococcal infection; Neisseria meningitidis; Menactra®; Menomune®

Additional relevant MeSH terms:

Meningococcal Infections; Meningitis; Infections; Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses