Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
NCT ID: NCT00662870
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1941 participants
INTERVENTIONAL
2001-05-31
2004-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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DAPTACEL Lot 1
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1
DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
DAPTACEL Lot 2
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2
DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
DAPTACEL Lot 3
Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3
DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Pentacel
Participants receiving Pentacel vaccine
Pentacel: DTaP-IPV/Hib
0.5 mL, Intramuscular
Interventions
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DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, Intramuscular
Pentacel: DTaP-IPV/Hib
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
42 Days
84 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur, Inc.
Locations
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Fayetteville, AR 72703, Arkansas, United States
Jonesboro, AR 72401, Arkansas, United States
Little Rock, AR 72211, Arkansas, United States
Fountain Valley, CA 92708, California, United States
Englewood, CO 80112, Colorado, United States
Norwich, CT 06360, Connecticut, United States
Orlando, FL 32856, Florida, United States
Marietta, GA 30062, Georgia, United States
Chicago, IL 60614, Illinois, United States
Bardstown, KY 40004, Kentucky, United States
Bossier City, LA 71111, Louisiana, United States
Bridgeton, MO 63044, Missouri, United States
Rochester, NY 14620, New York, United States
Chapel Hill, NC 27514, North Carolina, United States
Portland, OR 97201, Oregon, United States
Norristown, PA 19401, Pennsylvania, United States
Pittsburgh, PA 15213, Pennsylvania, United States
Pittsburgh, PA 15241, Pennsylvania, United States
Kingsport, TN 37664, Tennessee, United States
Austin, TX 78758, Texas, United States
Fort Worth, TX 76107, Texas, United States
San Antonio, TX 78205, Texas, United States
Provo, UT 84604, Utah, United States
Spokane, WA 99220, Washington, United States
LaCrosse, WI 54601, Wisconsin, United States
Marshfield, WI 54449, Wisconsin, United States
Countries
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References
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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.
Related Links
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Related Info
Other Identifiers
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P3T06
Identifier Type: -
Identifier Source: org_study_id
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