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Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

Primary Purpose

Meningococcal Meningitis, Tetanus, Diphtheria

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

About this trial

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis

Eligibility Criteria

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

Inclusion Criteria: Healthy, as determined by medical history and physical examination. Aged 4 to < 7 years at the time of study vaccination on Day 0. Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series. Exclusion Criteria: Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic) Known or suspected impairment of immunologic function Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment History of documented invasive meningococcal disease or previous meningococcal vaccination Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study. Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment. Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw. Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances. Thrombocytopenia or a bleeding disorder contraindicating IM vaccination. 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. Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study. Personal or family history of Guillain-Barré Syndrome (GBS).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

DAPTACEL® + IPOL on Day 0 and Menactra on Day 30

DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30

Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30

Outcomes

Primary Outcome Measures

Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

Secondary Outcome Measures

Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.

Full Information

First Posted
July 20, 2006
Last Updated
August 22, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00355121
Brief Title
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Official Title
Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis
Keywords
Meningococcal meningitis, Tetanus, Diphtheria, Pertussis, Poliomyelitis, Neisseria meningitidis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
882 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
Arm Title
Group 2
Arm Type
Experimental
Arm Description
DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Other Intervention Name(s)
Menactra®, DAPTACEL®, IPOL
Intervention Description
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Other Intervention Name(s)
Menactra®, DAPTACEL®, IPOL
Intervention Description
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
Intervention Type
Biological
Intervention Name(s)
Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Other Intervention Name(s)
Menactra®, DAPTACEL®, IPOL
Intervention Description
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
Primary Outcome Measure Information:
Title
Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
Description
Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
Time Frame
Day 30 post-vaccination (Visit 1)
Title
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
Description
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time Frame
Day 30 post-vaccination (Visit 1)
Secondary Outcome Measure Information:
Title
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
Description
Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).
Time Frame
Day 30 post-vaccination 1
Title
Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
Description
Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
Time Frame
Day 30 post-vaccination
Title
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
Description
Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Time Frame
Day 0 through Day 7 post-vaccination at Visit 1
Other Pre-specified Outcome Measures:
Title
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
Description
Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.
Time Frame
Day 30 post-vaccination
Title
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
Description
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame
Day 0 through Day 7 post-vaccination
Title
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
Description
Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame
Day 0 through Day 7 post-vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy, as determined by medical history and physical examination. Aged 4 to < 7 years at the time of study vaccination on Day 0. Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian. Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series. Exclusion Criteria: Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic) Known or suspected impairment of immunologic function Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment History of documented invasive meningococcal disease or previous meningococcal vaccination Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study. Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrollment. Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw. Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances. Thrombocytopenia or a bleeding disorder contraindicating IM vaccination. 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. Diagnosed with any condition, which, in the opinion of the physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study. Personal or family history of Guillain-Barré Syndrome (GBS).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Layton, UT 84041
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
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
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
City
University Heights
State/Province
Ohio
ZIP/Postal Code
44118
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
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

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