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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00662870
First received: April 17, 2008
Last updated: January 26, 2012
Last verified: January 2012

April 17, 2008
January 26, 2012
May 2001
January 2004   (final data collection date for primary outcome measure)
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. [ Time Frame: 30 days post-vaccination 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00662870 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
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.

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.

This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Diphtheria
  • Tetanus
  • Whooping Cough
  • Polio
  • Haemophilus Influenzae Type b
  • 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
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1941
January 2004
January 2004   (final data collection date for primary outcome measure)

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
Both
42 Days to 84 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00662870
P3T06
No
Sanofi
Sanofi
Not Provided
Study Director: Medical Monitor Sanofi Pasteur, Inc.
Sanofi
January 2012

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