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

Completed

• Conditions: Meningitis; Meningococcal Infections
• Interventions: Biological: Menomune®; Biological: Menactra®

• Registration Number: NCT00862277
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-03
• Study First Submitted: 2009-03-13
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Study Completion: 2009-12
• Results First Submitted: 2010-12-11
• Results First Submitted QC: 2011-01-12
• Results First Posted: 2011-01-13
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 763

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Menomune® from Previous Study	Menomune®	Subjects previously received only one dose of meningococcal vaccine, Menomune® in Study MTA04
Group 1: Menactra® from Previous Studies	Menactra®	Subjects previously received only one dose of meningococcal vaccine, Menactra® in Study MTA04, MTA12, MTA19, or MTA21.

Primary Outcome Measures

Name	Time	Method
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
Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment	Day 0