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

Primary Purpose

Meningitis, Meningococcemia

Status

Terminated

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

About this trial

This is an interventional prevention trial for Meningitis focused on measuring Menactra®, Meningitis, Meningococcemia, Neisseria meningitidis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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 ≥ 38°C 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

Subjects naïve to any meningococcal vaccination

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00772629

First Posted

October 13, 2008

Last Updated

January 21, 2014

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT00772629

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

See detailed description for termination reason

Study Start Date

January 2004 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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. There were no safety concerns involved in the decision to stop enrollment. Subjects that were enrolled at the time completed the study as per protocol, the last subject last visit was on 29 April 2004.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Meningococcemia

Keywords

Menactra®, Meningitis, Meningococcemia, Neisseria meningitidis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Subjects naïve to any meningococcal vaccination

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Other Intervention Name(s)

Menactra®

Intervention Description

0.5 mL, Intramuscular

Intervention Type

Biological

Intervention Name(s)

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Other Intervention Name(s)

Menactra®

Intervention Description

0.5 mL, Intramuscular

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Day 28 post-vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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 ≥ 38°C 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Sanofi Pasteur Inc.

Official's Role

Study Director

Facility Information:

City

Bristol

Country

United Kingdom

City

London

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://www.sanofipasteur.com

Description

Related Info

Learn more about this trial

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

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