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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00772629

Purpose

This study was designed to generate data for the assessment of Menactra vaccine 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 Menactra vaccine, as measured by serum bactericidal activity using baby rabbit complement (SBA BR) in participants in each of the two study groups.

Condition	Intervention	Phase
Meningitis Meningococcemia	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	Phase II

MedlinePlus related topics: Diphtheria Meningitis

Drug Information available for: Immunoglobulins Globulin, Immune Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Antibody Responses Following Meningococcal Tetravalent (A, C, Y, and W-135) Conjugate Vaccination in Healthy Adults Who Were Either Previously Vaccinated With Unconjugated Meningococcal Polysaccharide (Serogroups A, C or Serogroups A, C, Y, and W-135) Vaccine or Not Vaccinated With Meningococcal Vaccine

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immune response of a tetravalent meningococcal polysaccharide diphtheria conjugate vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]
Safety: To provide information concerning the safety after administration of a tetravalent meningococcal polysaccharide diphtheria conjugate vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	January 2004
Study Completion Date:	April 2004
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Subjects naïve to any meningococcal vaccination	Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate 0.5 mL, Intramuscular
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 0.5 mL, Intramuscular

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

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.

Exclusion Criteria :

Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
Known or suspected impairment of immunologic function
Acute medical illness with or without fever within the last 72 hours or an oral temperature >=38oC at the time of inclusion
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772629

Locations

United Kingdom

London, United Kingdom

Bristol, United Kingdom

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur Inc.

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	MTA16
Study First Received:	October 13, 2008
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00772629
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Sanofi-Aventis:

Meningitis
Meningococcemia
Neisseria meningitidis

Study placed in the following topic categories:

Antibodies
Meningococcemia
Central Nervous System Infections
Central Nervous System Diseases

Neisseria meningitidis
Healthy
Immunoglobulins
Meningitis

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009