Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults

NCT00772629 | Terminated Phase 2 Results

• 1 other identifier: MTA16
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This study was designed to generate data for the assessment of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®) when given to adults aged 18 to 55 years. Primary Objective: To describe the antibody response to each serogroup prior to, and 4 to 6 weeks following, the administration of one dose of the investigational Meningococcal Polysaccharide Diphtheria Toxoid Conjugate vaccine (Menactra®), as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups. Secondary Objective: To collect reference sera for the development and refinement of laboratory assays for the measurement of antibody responses to serogroups Y and W 135.

Conditions

Meningitis; Meningococcemia

Keywords

Menactra®; Meningitis; Meningococcemia; Neisseria meningitidis

Outcome Measures

Primary Outcomes (1)

• Participants With a ≥ 4-fold Rise in Antibody Titers as Measured by Serum Bactericidal Assay (SBA) From Day 0 to Day 28.

  Number of participants with a minimum of 4 fold rise in Antibody Titers as Measured SBA to each vaccine meningococcal serogroups from Baseline to Day 28.

  Day 28 post-vaccination

Study Arms (2)

Group 1

EXPERIMENTAL

Subjects naïve to any meningococcal vaccination

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Group 2

EXPERIMENTAL

Subjects who previously received unconjugated polysaccharide vaccine (either bivalent A and C or tetravalent A, C, Y, and W 135)

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Group 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant was at least 18 years of age but not yet 56 years of age at the time of vaccination.
• Participant had received either unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine at least one year prior to enrollment (for assignment to Group 2) or had no prior history of meningococcal vaccination (for assignment to Group 1).
• Participant had signed Ethics Committee-approved informed consent form.

You may not qualify if:

• Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
• Known or suspected impairment of immunologic function
• History of documented invasive meningococcal disease
• Administration of immune globulin or other blood products within the last three months, or injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days were allowed to be included in the trial as long as they had not received more than one course within the last two weeks prior to enrollment.
• Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing the blood sample at Visit 2
• Received unconjugated meningococcal polysaccharide (serogroups A and C, or A, C, Y, and W 135) vaccine within the one-year period prior to enrollment or a conjugated meningococcal vaccine at any time prior to enrollment
• Received any vaccine in the 28-day period prior to enrollment, or scheduled to receive any vaccination during participation in the study
• Suspected or known hypersensitivity to any of the vaccine components
• Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures
• Enrolled in another clinical trial
• In females, pregnancy confirmed by positive urine test result
• In females, current breastfeeding.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Bristol, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Enrollment was terminated before the planned sample size was achieved because the principal investigator and the Sponsor decided that sufficient sera had been obtained to meet the secondary objective of the study.

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2008
• First Posted: October 15, 2008
• Study Start: January 1, 2004
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: February 14, 2014
• Results First Posted: April 27, 2009

Record last verified: 2014-01

Locations

GB (2)