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

Brief Title

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

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.

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 Phase

Phase 3

Study Type

Interventional

Primary Outcome

Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.

Condition

Diphtheria

Intervention

DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)

Study Arms / Comparison Groups

 DAPTACEL Lot 1

Description:  Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

1941

Start Date

May 2001

Completion Date

January 2004

Primary Completion Date

January 2004

Eligibility 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
      

Gender

All

Ages

42 Days - 84 Days

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT00662870

Organization ID

P3T06

Responsible Party

Sponsor

Study Sponsor

Sanofi

Study Sponsor

Medical Monitor, Study Director, Sanofi Pasteur, Inc.

Verification Date

January 2012