Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862277
• Other study ID #: MTA64
• 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

• Meningitis
• Meningococcal Infections

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

External Links

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