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Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

Primary Purpose

Meningitis, Meningococcal Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Polysaccharide Diphtheria Conjugate Vaccine
Polysaccharide Diphtheria Conjugate Vaccine
Polysaccharide Diphtheria Conjugate Vaccine
Polysaccharide Diphtheria Conjugate Vaccine
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

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Subject is healthy, as determined by medical history. Subject is between the ages of 7 and 15 years (not yet 16 years). For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23. A negative urine pregnancy test is required for menstruating female subjects. Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form. Exclusion Criteria: Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study) History of documented invasive meningococcal disease Received any other meningococcal vaccine Received any vaccine in the 28-day period prior to enrollment Received 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, 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 Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) 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 of family history of Guillain-Barres 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

Experimental

Experimental

Arm Label

Menactra® Group 1

Menactra® Group 2

Meningococcal Vaccine-naïve Group 3

Meningococcal Vaccine-naïve Group 4

Arm Description

Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.

Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.

Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.

Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.

Outcomes

Primary Outcome Measures

Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
January 21, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00258856
Brief Title
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Official Title
Persistence of Bactericidal Antibodies in Children Aged 7 to 15 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
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
November 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 7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study 603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of participants who will receive a booster dose of Menactra® vaccine and children in the same age group not previously vaccinated with a meningococcal vaccine or had meningitis disease who will 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
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Menactra® Group 1
Arm Type
Experimental
Arm Description
Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination.
Arm Title
Menactra® Group 2
Arm Type
Experimental
Arm Description
Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination.
Arm Title
Meningococcal Vaccine-naïve Group 3
Arm Type
Experimental
Arm Description
Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
Arm Title
Meningococcal Vaccine-naïve Group 4
Arm Type
Experimental
Arm Description
Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Conjugate Vaccine
Other Intervention Name(s)
Menactra®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of Participants With Serum Bactericidal Activity of ≥ 1:8 for the Menactra® Meningococcal Serogroups Pre-vaccination, and at 7 Days or 14 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 the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
Time Frame
7 or 14 days post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 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 7 and 15 years (not yet 16 years). For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. The date of vaccination during Study 603-02 will have occurred 5 years ± 6 months before the collection of the blood sample obtained for Study MTA23. A negative urine pregnancy test is required for menstruating female subjects. Parent/legal guardian has signed an Institutional Review Board (IRB)-approved informed consent form and subject has signed an IRB-approved assent form. Exclusion Criteria: Subjects who participated in sanofi pasteur Study MTA17 Stage I (a subset of subjects from Study 603-02 who had been recruited for the follow-up challenge study) History of documented invasive meningococcal disease Received any other meningococcal vaccine Received any vaccine in the 28-day period prior to enrollment Received 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, 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 Scheduled to receive any vaccination in the 7-day or 14-day period after enrollment Administration of immune globulin, other blood products, or corticosteroid within 8 weeks (56 days) 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 of family history of Guillain-Barres 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
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1559
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
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 Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®

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