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Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00662870
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.

Stage I Primary Objectives:

  1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
  2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
  3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.

Stage II Primary Objectives:

  1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
  2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Condition or disease Intervention/treatment Phase
Diphtheria Tetanus Whooping Cough Polio Haemophilus Influenzae Type b Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) Biological: Pentacel: DTaP-IPV/Hib Phase 3

Detailed Description:
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1941 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
Study Start Date : May 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DAPTACEL Lot 1
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1
 Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Name: DAPTACEL®
Experimental: DAPTACEL Lot 2
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2
 Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Name: DAPTACEL®
Experimental: DAPTACEL Lot 3
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3
 Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Other Name: DAPTACEL®
Active Comparator: Pentacel
Participants receiving Pentacel vaccine
 Biological: Pentacel: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Name: Pentacel


Outcome Measures
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Primary Outcome Measures :
  1. Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. [ Time Frame: 30 days post-vaccination 3 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   42 Days to 84 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Healthy infants 2 months of age.
  • Infants with at least 37 weeks of gestation at delivery.
  • Signed informed consent from parent or guardian.
  • Able to attend the scheduled visits and to comply with the study procedure.
  • Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

Exclusion Criteria :

  • Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
  • Known or suspected hypersensitivity to any component of the study vaccine to be administered.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Known HIV-positive mother.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay or neurologic disorders.
  • Chronic medical, congenital, developmental or surgical disease.
  • Participation in any other experimental vaccine trial.
  • Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
  • Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00662870


Locations
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United States, Arkansas
Fayetteville, AR 72703, Arkansas, United States, 72703
Jonesboro, AR 72401, Arkansas, United States, 7240
Little Rock, AR 72211, Arkansas, United States, 72211
United States, California
Fountain Valley, CA 92708, California, United States, 92708
United States, Colorado
Englewood, CO 80112, Colorado, United States, 80112
United States, Connecticut
Norwich, CT 06360, Connecticut, United States, 06360
United States, Florida
Orlando, FL 32856, Florida, United States, 32856
United States, Georgia
Marietta, GA 30062, Georgia, United States, 30062
United States, Illinois
Chicago, IL 60614, Illinois, United States, 60614
United States, Kentucky
Bardstown, KY 40004, Kentucky, United States, 40004
United States, Louisiana
Bossier City, LA 71111, Louisiana, United States, 71111
United States, Missouri
Bridgeton, MO 63044, Missouri, United States, 63044
United States, New York
Rochester, NY 14620, New York, United States, 14620
United States, North Carolina
Chapel Hill, NC 27514, North Carolina, United States, 27514
United States, Oregon
Portland, OR 97201, Oregon, United States, 97201
United States, Pennsylvania
Norristown, PA 19401, Pennsylvania, United States, 19401
Pittsburgh, PA 15213, Pennsylvania, United States, 15213
Pittsburgh, PA 15241, Pennsylvania, United States, 15241
United States, Tennessee
Kingsport, TN 37664, Tennessee, United States, 37664
United States, Texas
Austin, TX 78758, Texas, United States, 78758
Fort Worth, TX 76107, Texas, United States, 76106
San Antonio, TX 78205, Texas, United States, 78205
United States, Utah
Provo, UT 84604, Utah, United States, 84604
United States, Washington
Spokane, WA 99220, Washington, United States, 99220
United States, Wisconsin
LaCrosse, WI 54601, Wisconsin, United States, 54601
Marshfield, WI 54449, Wisconsin, United States, 54449
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Monitor Sanofi Pasteur, Inc.
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00662870    
Other Study ID Numbers: P3T06
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012
Keywords provided by Sanofi:
DAPTACEL
Diphtheria
Tetanus
Whooping Cough
 Polio
Haemophilus influenzae type b
Pertussis
Additional relevant MeSH terms:
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Tetanus
Diphtheria
Whooping Cough
Tetany
Respiratory Tract Infections
Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Corynebacterium Infections
Actinomycetales Infections
Bordetella Infections
Gram-Negative Bacterial Infections