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Safety and Immune Response of Different Pediatric Combination Vaccines.

Primary Purpose

Diphtheria, Polio, Pertussis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
Pentacel®: DTaP-IPV/Hib combined
DTaP-IPV and ActHIB®
Pentacel®: DTaP-IPV/Hib combined
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 Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.

Eligibility Criteria

42 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged ≥ 42 days and ≤ 89 days on the day of inclusion Born at full term of pregnancy (≥ 36 weeks) Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure Vaccination with a hepatitis B vaccine at least 30 days before inclusion Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone) Provide blood sample prior to Dose 1 Parent or legal representative willing to take rectal temperatures after each vaccination. Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination Planned participation in another clinical trial during the present trial period Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s) Chronic illness that could interfere with trial conduct or completion Received blood or blood-derived products since birth Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines Coagulation disorder contraindicating intramuscular (IM) vaccination Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion) Developmental delay or neurological disorder Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Study Group 1: DAPTACEL®, ActHIB®, and IPOL®

Study Group 2: Pentacel®

Study Group 3: DTaP-IPV and ActHIB®

Study Group 4: Pentacel®

Arm Description

Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively

Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively

Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively

Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively

Outcomes

Primary Outcome Measures

Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2005
Last Updated
January 21, 2014
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00255047
Brief Title
Safety and Immune Response of Different Pediatric Combination Vaccines.
Official Title
Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Polio, Pertussis
Keywords
Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Arm Type
Experimental
Arm Description
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
Arm Title
Study Group 2: Pentacel®
Arm Type
Experimental
Arm Description
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Arm Title
Study Group 3: DTaP-IPV and ActHIB®
Arm Type
Experimental
Arm Description
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
Arm Title
Study Group 4: Pentacel®
Arm Type
Experimental
Arm Description
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Intervention Type
Biological
Intervention Name(s)
DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
Other Intervention Name(s)
DAPTACEL®, IPOL®, ActHIB®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pentacel®: DTaP-IPV/Hib combined
Other Intervention Name(s)
Pentacel®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV and ActHIB®
Other Intervention Name(s)
ActHIB®
Intervention Description
0.5 mL, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pentacel®: DTaP-IPV/Hib combined
Other Intervention Name(s)
Pentacel®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Description
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Time Frame
30 Days post-dose 3 vaccination
Title
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Time Frame
30 Days post-dose 3 vaccination
Title
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Time Frame
30 Days post-dose 3 vaccination.
Other Pre-specified Outcome Measures:
Title
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Description
Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Time Frame
7 days post-vaccination 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged ≥ 42 days and ≤ 89 days on the day of inclusion Born at full term of pregnancy (≥ 36 weeks) Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure Vaccination with a hepatitis B vaccine at least 30 days before inclusion Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone) Provide blood sample prior to Dose 1 Parent or legal representative willing to take rectal temperatures after each vaccination. Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination Planned participation in another clinical trial during the present trial period Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s) Chronic illness that could interfere with trial conduct or completion Received blood or blood-derived products since birth Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines Coagulation disorder contraindicating intramuscular (IM) vaccination Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion) Developmental delay or neurological disorder Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
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
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35401
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
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
Fountain Valley
State/Province
California
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94613
Country
United States
City
Oakland
State/Province
California
ZIP/Postal Code
94618
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Bossier City
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Woburn
State/Province
Massachusetts
ZIP/Postal Code
01801
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Ithaca
State/Province
New York
Country
United States
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
City
Huber Heights
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44514
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
St George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
City
Marshfield
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22475857
Citation
Chatterjee A, O'Keefe C, Varman M, Klein NP, Luber S, Tomovici A, Noriega F. Comparative immunogenicity and safety of different multivalent component pertussis vaccine formulations and a 5-component acellular pertussis vaccine in infants and toddlers: a randomized, controlled, open-label, multicenter study. Vaccine. 2012 May 14;30(23):3360-8. doi: 10.1016/j.vaccine.2012.03.057. Epub 2012 Apr 1.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info

Learn more about this trial

Safety and Immune Response of Different Pediatric Combination Vaccines.

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