search
Back to results

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DAPTACEL®: DTaP
DAPTACEL®: DTaP
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring DAPTACEL®, Pentacel™, Diphtheria, Tetanus, Pertussis, Whooping cough, Acellular Pertussis Vaccine Adsorbed

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged ≥ 4 and < 7 years from date of birth at the time of study vaccination Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB Judged to be in good health on the basis of reported medical history and physical examination Able and willing to attend the scheduled visits and to comply with the study procedures Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™). Exclusion Criteria: Received a 5th dose of DTaP-containing vaccine a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age. b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination Known or suspected primary or acquired disease of the immune system Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. 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 1 course within the last 2 weeks prior to enrollment Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable) Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine Enrolled in another vaccine trial Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DAPTACEL Primed

Pentacel Primed

Arm Description

Participants received Daptacel in Study P3T06.

Participants received Pentacel in Study P3T06

Outcomes

Primary Outcome Measures

Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination

Secondary Outcome Measures

Full Information

First Posted
November 24, 2005
Last Updated
April 12, 2016
Sponsor
Sanofi Pasteur, a Sanofi Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00258895
Brief Title
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Official Title
Safety and Immunogenicity of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With DAPTACEL® or Pentacel®
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Primary Objectives: To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. Observational Objectives: To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a 2nd dose of MMR.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Tetanus, Pertussis
Keywords
DAPTACEL®, Pentacel™, Diphtheria, Tetanus, Pertussis, Whooping cough, Acellular Pertussis Vaccine Adsorbed

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
649 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DAPTACEL Primed
Arm Type
Experimental
Arm Description
Participants received Daptacel in Study P3T06.
Arm Title
Pentacel Primed
Arm Type
Experimental
Arm Description
Participants received Pentacel in Study P3T06
Intervention Type
Biological
Intervention Name(s)
DAPTACEL®: DTaP
Other Intervention Name(s)
DAPTACEL®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DAPTACEL®: DTaP
Other Intervention Name(s)
DAPTACEL®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Time Frame
0 to 7 days Post-Dose 5
Title
Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
Description
Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Time Frame
Day 28 to 48 Post-dose 5
Title
Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
Description
Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
Time Frame
Day 28 to 48 Post-Dose 5
Title
Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Time Frame
Day 0 and between Days 28-48 Post-dose 5
Title
Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Time Frame
Day 0 and between Days 28-48 post-dose 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥ 4 and < 7 years from date of birth at the time of study vaccination Signed and dated Investigational Review Board (IRB)-approved informed consent from a parent or legally authorized representative. Signed and dated IRB-approved assent from subject if required by IRB Judged to be in good health on the basis of reported medical history and physical examination Able and willing to attend the scheduled visits and to comply with the study procedures Has documented complete infant series and the 4th dose of DAPTACEL® or Pentacel™ in Study P3T06 (i.e., 4 previous administrations of DAPTACEL® or Pentacel™). Exclusion Criteria: Received a 5th dose of DTaP-containing vaccine a. For subjects in the DAPTACEL® arm: Received a 4th dose of Inactivated Poliovirus Vaccine (IPV) vaccine and/or a 2nd dose of Measles, Mumps, and Rubella (MMR) vaccine scheduled at 4 to 6 years of age. b. For subjects in the Pentacel™ arm: Received a 2nd dose of MMR vaccine scheduled at 4 to 6 years of age Severe hypersensitivity to any component of the vaccine such as an anaphylactic reaction observed following a previous vaccination Serious underlying chronic disease, including, but not limited to:·Diabetes mellitus; malignancy; cardiopulmonary disease; renal, endocrinologic, or hepatic dysfunction; or hematologic disorder·Unstable or evolving neurologic disorders that may predispose the subject to seizures or neurologic deterioration. These may include progressive neurologic disorders (e.g., infantile spasms, uncontrolled progressive encephalopathy) and encephalopathy within 7 days following previous vaccination Known or suspected primary or acquired disease of the immune system Administration of immune globulin, other blood products within the last 3 months, injected or oral corticosteroids or other immunomodulator therapy within 6 weeks prior to study vaccination. 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 1 course within the last 2 weeks prior to enrollment Had allergy shots started or had changes in regimen or dosing of allergy shots within 4 weeks prior to study vaccination Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (if applicable) Any other condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine Enrolled in another vaccine trial Personal history of physician-diagnosed or laboratory-confirmed pertussis disease within the past 30 months Known or suspected allergy to any of the vaccines or vaccine components intended for use in this study.
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
Fayetteville
State/Province
Arkansas
Country
United States
City
Jonesboro
State/Province
Arkansas
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Fountain Valley
State/Province
California
Country
United States
City
Centennial
State/Province
Colorado
Country
United States
City
Norwich
State/Province
Connecticut
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Bardstown,
State/Province
Kentucky
Country
United States
City
Bossier City
State/Province
Louisiana
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Pembroke
State/Province
North Carolina
Country
United States
City
Sylva
State/Province
North Carolina
Country
United States
City
Norristown
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Kingsport
State/Province
Tennessee
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Provo
State/Province
Utah
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
LaCrosse
State/Province
Wisconsin
Country
United States
City
Marshfield
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

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

Learn more about this trial

Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

We'll reach out to this number within 24 hrs