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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00862277
Other study ID # MTA64
Secondary ID
Status Completed
Phase N/A
First received March 13, 2009
Last updated April 12, 2016
Start date December 2008
Est. completion date December 2009

Study information

Verified date April 2016
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 763
Est. completion date December 2009
Est. primary completion date March 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 27 Years
Eligibility 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)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Biological:
Menactra®
0.5 mL, Intramuscular (from a previous study)
Menomune®
0.5 mL, Intramuscular (from a previous study)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at = 8 and = 128 at Enrollment Day 0 No
Primary Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment Day 0 No
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