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Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

Primary Purpose

Meningitis, Meningococcal Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

15 Years - 23 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subject is healthy, as determined by medical history. Subject is between the ages of 15 and 23 years (not yet 24 years). For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study) Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form. Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications A negative urine pregnancy test is required for menstruating female subjects. Exclusion Criteria: History of documented invasive meningococcal disease. Received any other meningococcal vaccine Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment Scheduled to receive any vaccination in the 28-day period after enrollment Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample Actively enrolled or scheduled to be enrolled in another clinical study Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system) Known or suspected impairment of immunologic function Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Personal or family history of Guillain-Barre Syndrome 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 Any condition, which in the opinion of the investigator would pose a health risk to the participant.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Menactra® Vaccine Group 1

Menactra® Vaccine Group 2

Meningococcal Vaccine-naive Group 3

Meningococcal Vaccine-naive Group 4

Arm Description

Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.

Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination

Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.

Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.

Outcomes

Primary Outcome Measures

Participants With Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.
Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2005
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00269477
Brief Title
Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®
Official Title
Persistence of Bactericidal Antibodies in Adolescents and Adults Aged 15 to 23 Years Who Received a Single Dose of Menactra® or Menomune®-A/C/Y/W-135 Five Years Earlier
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged 15 to 23 years (not yet 24 years) who had been vaccinated five years previously in Study MTA02 and did not participate in Study MTA19 (NCT 00777790). In addition, the kinetics of the antibody response will be evaluated in a subset of these participants who will receive a booster dose of Menactra® vaccine. This will be compared to aged matched control subjects who have not been previously vaccinated with a meningococcal vaccine or had documented meningitis disease who will also receive a dose of Menactra® vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal Infection
Keywords
Meningitis, Meningococcal infection, Neisseria meningitidis, Menactra®, Menomune®

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menactra® Vaccine Group 1
Arm Type
Experimental
Arm Description
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Arm Title
Menactra® Vaccine Group 2
Arm Type
Experimental
Arm Description
Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra® vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination
Arm Title
Meningococcal Vaccine-naive Group 3
Arm Type
Active Comparator
Arm Description
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
Arm Title
Meningococcal Vaccine-naive Group 4
Arm Type
Active Comparator
Arm Description
Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra® vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
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
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 Serum Bactericidal Activity of ≥ 1:8 for Each Menactra® Vaccine Serogroups Pre-vaccination and 28 Days Post-booster or Post-primary Dose Vaccination.
Description
Groups 1 and 2 received booster vaccination, Groups 3 and 4 received primary vaccination. Serum bactericidal activity for each Menactra® vaccine serogroups were at pre-vaccination and at 28 days post-booster or post-primary vaccination.
Time Frame
28 days post-vaccination (5 years after Menactra® or Menomune® vaccination)
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions
Description
Solicited injection site reactions: Erythema, Swelling, and Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time Frame
Day 0 to 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject is healthy, as determined by medical history. Subject is between the ages of 15 and 23 years (not yet 24 years). For subjects who participated in Study MTA02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. Did not participate in Study MTA19 (a subset of subjects from Study MTA02 who had been recruited for a follow-up challenge study) Subject or parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form. Before recruitment for the second part of the study, subjects should be thoroughly screened to ensure that they are able to comply with protocol specifications A negative urine pregnancy test is required for menstruating female subjects. Exclusion Criteria: History of documented invasive meningococcal disease. Received any other meningococcal vaccine Received any vaccine (other than desensitization therapy for allergies) in the 28-day period prior to enrollment Scheduled to receive any vaccination in the 28-day period after enrollment Received systemic antibiotic therapy within the 72 hours prior to collection of a blood sample Actively enrolled or scheduled to be enrolled in another clinical study Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, hematologic, psychiatric, or other organ system) Known or suspected impairment of immunologic function Acute medical illness with or without fever within 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of inclusion Administration of immune globulin, other blood products, or corticosteroid within 3 months of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Personal or family history of Guillain-Barre Syndrome 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 Any condition, which in the opinion of the investigator would pose a health risk to the participant.
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Persistence of Antibodies in Adolescents and Adults 15 to 23 Years Who Received One Dose of Menactra® or Menomune®

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