Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

Meningitis Clinical Trial

Official title:

Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately Four Years Earlier

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633787
• Other study ID #: MTA00093
• Secondary ID: U1111-1161-3151
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2015
• Last updated: March 1, 2016
• Start date: December 2015
• Est. completion date: March 2016

Study information

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

Clinical Trial Summary

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).

Objective:

• To evaluate the persistence of antibody responses (determined by serum bactericidal assay using human complement [SBA-HC]) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

Description:

All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged = 18 years on the day of inclusion

• Received booster dose of Menactra vaccine in trial MTA77

• Informed consent form has been signed and dated

• Able to attend the scheduled visit and to comply with all trial procedures.

Exclusion Criteria:

• Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically

• Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Current alcohol abuse or drug addiction

• Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results

• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)

• Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be administered in this trial

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	Number of participants with meningococcal antibody titers = 1:4 and = 1:8 for serogroups A, C, Y, and W35	Meningococcal antibody titers for serogroups A, C, Y, and W 135, as determined by serum Bactericidal assay using human complement (SBA HC)	Approximately 4 years following a booster dose of Menactra	No

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