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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00662870

Purpose

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:

To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
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:

To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Condition	Intervention	Phase
Diphtheria Tetanus Whooping Cough Polio Haemophilus Influenzae Type B	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) Biological: DTaP-IPV/Hib	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cough Diphtheria Flu Polio and Post-Polio Syndrome Tetanus Whooping Cough

Drug Information available for: Tetanus Vaccine

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. [ Time Frame: 30 days post-vaccination 3 ] [ Designated as safety issue: No ]

Enrollment:	1941
Study Start Date:	May 2001
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lot 1	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, IM
2: Experimental Lot 2	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, IM
3: Experimental Lot 3	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, IM
4: Active Comparator	Biological: DTaP-IPV/Hib 0.5 mL, IM

Detailed Description:

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

Eligibility

Ages Eligible for Study:	42 Days to 84 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662870

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Locations

United States, Arkansas

Jonesboro, AR 72401, Arkansas, United States, 7240

Fayetteville, AR 72703, Arkansas, United States, 72703

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

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

Englewood, CO 80112, Colorado, United States, 80112
United States, Connecticut

Norwich, CT 06360, Connecticut, United States, 06360
United States, Florida

Orlando, FL 32856, Florida, United States, 32856
United States, Georgia

Marietta, GA 30062, Georgia, United States, 30062
United States, Illinois

Chicago, IL 60614, Illinois, United States, 60614
United States, Kentucky

Bardstown, KY 40004, Kentucky, United States, 40004
United States, Louisiana

Bossier City, LA 71111, Louisiana, United States, 71111
United States, Missouri

Bridgeton, MO 63044, Missouri, United States, 63044
United States, New York

Rochester, NY 14620, New York, United States, 14620
United States, North Carolina

Chapel Hill, NC 27514, North Carolina, United States, 27514
United States, Oregon

Portland, OR 97201, Oregon, United States, 97201
United States, Pennsylvania

Pittsburgh, PA 15241, Pennsylvania, United States, 15241

Pittsburgh, PA 15213, Pennsylvania, United States, 15213

Norristown, PA 19401, Pennsylvania, United States, 19401
United States, Tennessee

Kingsport, TN 37664, Tennessee, United States, 37664
United States, Texas

San Antonio, TX 78205, Texas, United States, 78205

Fort Worth, TX 76107, Texas, United States, 76106

Austin, TX 78758, Texas, United States, 78758
United States, Utah

Provo, UT 84604, Utah, United States, 84604
United States, Washington

Spokane, WA 99220, Washington, United States, 99220
United States, Wisconsin

LaCrosse, WI 54601, Wisconsin, United States, 54601

Marshfield, WI 54449, Wisconsin, United States, 54449

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Monitor

Sanofi Pasteur, Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers:	P3T06
Study First Received:	April 17, 2008
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00662870 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

DAPTACEL
Diphtheria
Tetanus
Whooping Cough

Polio
Haemophilus influenzae type b
Pertussis

Additional relevant MeSH terms:

Bacterial Infections
Spinal Cord Diseases
Whooping Cough
Central Nervous System Viral Diseases
Orthomyxoviridae Infections
Infection
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Neuromuscular Diseases
Corynebacterium Infections
Motor Neuron Disease

RNA Virus Infections
Nervous System Diseases
Picornaviridae Infections
Central Nervous System Diseases
Diphtheria
Actinomycetales Infections
Bordetella Infections
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human
Myelitis
Enterovirus Infections
Clostridium Infections

ClinicalTrials.gov processed this record on November 25, 2009