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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

Tracking Information
First Submitted Date  ICMJE April 17, 2008
First Posted Date  ICMJE April 21, 2008
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE May 2001
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. [ Time Frame: 30 days post-vaccination 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Official Title  ICMJE 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.
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.
Detailed Description This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Whooping Cough
  • Polio
  • Haemophilus Influenzae Type b
Intervention  ICMJE
  • Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
    0.5 mL, Intramuscular
    Other Name: DAPTACEL®
  • Biological: Pentacel: DTaP-IPV/Hib
    0.5 mL, Intramuscular
    Other Name: Pentacel
Study Arms  ICMJE
  • Experimental: DAPTACEL Lot 1
    Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1
    Intervention: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
  • Experimental: DAPTACEL Lot 2
    Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2
    Intervention: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
  • Experimental: DAPTACEL Lot 3
    Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3
    Intervention: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
  • Active Comparator: Pentacel
    Participants receiving Pentacel vaccine
    Intervention: Biological: Pentacel: DTaP-IPV/Hib
Publications * Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12. doi: 10.1542/peds.2007-3317.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
1941
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2004
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 84 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662870
Other Study ID Numbers  ICMJE P3T06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur, Inc.
PRS Account Sanofi
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP