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Status:

COMPLETED

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

Lead Sponsor:

Sanofi

Conditions:

Diphtheria

Tetanus

Eligibility:

All Genders

42-84 years

Phase:

PHASE3

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 ...

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2001

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2004

    Estimated Enrollment :

    1941 Patients enrolled

    Trial Details

    Trial ID

    NCT00662870

    Start Date

    May 1 2001

    End Date

    January 1 2004

    Last Update

    January 31 2012

    Active Locations (26)

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    Page 1 of 7 (26 locations)

    1

    Fayetteville, AR 72703, Arkansas, United States, 72703

    2

    Jonesboro, AR 72401, Arkansas, United States, 7240

    3

    Little Rock, AR 72211, Arkansas, United States, 72211

    4

    Fountain Valley, CA 92708, California, United States, 92708