Clinical trial NCT00269477: Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcal Infection
Keywords: Meningitis
Meningococcal infection
Neisseria meningitidis
Menactra®
Menomune®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 145
Sex: ALL
Minimum age (years): 15
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions
timeFrame: Day 0 to 7 post-vaccination
Locations:
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Woburn
country: United States
state: Massachusetts
city: Akron
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Sellersville
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: