Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Whooping Cough; Polio; Haemophilus Influenzae Type B
Intervention: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) (Biological); DTaP-IPV/Hib (Biological)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Sanofi Pasteur, Inc.
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.
Clinical Details
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Immunogenicity:
To provide information concerning the immune response of DAPTACEL after vaccination.
Detailed description:
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and
lot comparability of DAPTACEL
Eligibility
Minimum age: 42 Days.
Maximum age: 84 Days.
Gender(s): Both.
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
Locations and Contacts
Jonesboro, AR 72401, Arkansas 7240, United States
Fayetteville, AR 72703, Arkansas 72703, United States
Little Rock, AR 72211, Arkansas 72211, United States
Fountain Valley, CA 92708, California 92708, United States
Englewood, CO 80112, Colorado 80112, United States
Norwich, CT 06360, Connecticut 06360, United States
Orlando, FL 32856, Florida 32856, United States
Marietta, GA 30062, Georgia 30062, United States
Chicago, IL 60614, Illinois 60614, United States
Bardstown, KY 40004, Kentucky 40004, United States
Bossier City, LA 71111, Louisiana 71111, United States
Bridgeton, MO 63044, Missouri 63044, United States
Rochester, NY 14620, New York 14620, United States
Chapel Hill, NC 27514, North Carolina 27514, United States
Portland, OR 97201, Oregon 97201, United States
Pittsburgh, PA 15241, Pennsylvania 15241, United States
Pittsburgh, PA 15213, Pennsylvania 15213, United States
Norristown, PA 19401, Pennsylvania 19401, United States
Kingsport, TN 37664, Tennessee 37664, United States
San Antonio, TX 78205, Texas 78205, United States
Fort Worth, TX 76107, Texas 76106, United States
Austin, TX 78758, Texas 78758, United States
Provo, UT 84604, Utah 84604, United States
Spokane, WA 99220, Washington 99220, United States
LaCrosse, WI 54601, Wisconsin 54601, United States
Marshfield, WI 54449, Wisconsin 54449, United States
Additional Information
Starting date: May 2001
Ending date: January 2004
Last updated: April 18, 2008
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