Clinical trial NCT00862277: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningococcal Infections
Meningitis
Keywords: Menactra®
Menomune®
Meningitis
Meningococcal Infections
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 763
Sex: ALL
Minimum age (years): 14
Maximum age (years): 27
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment
timeFrame: Day 0
measure: Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Fountain Valley
country: United States
state: California
city: Marietta
country: United States
state: Georgia
city: Martinez
country: United States
state: Georgia
city: Woodstock
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Omaha
country: United States
state: Nebraska
city: Austintown
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Erie
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: Pennsylvania
city: Harleysville
country: United States
state: Pennsylvania
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Wexford
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Spokane
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: