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 (Responsible Party):	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: Pentacel: DTaP-IPV/Hib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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
Experimental: DAPTACEL Lot 1 Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, Intramuscular Other Name: DAPTACEL®
Experimental: DAPTACEL Lot 2 Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, Intramuscular Other Name: DAPTACEL®
Experimental: DAPTACEL Lot 3 Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3	Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) 0.5 mL, Intramuscular Other Name: DAPTACEL®
Active Comparator: Pentacel Participants receiving Pentacel vaccine	Biological: Pentacel: DTaP-IPV/Hib 0.5 mL, Intramuscular Other Name: Pentacel

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

Show 26 Study Locations

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-Aventis
ClinicalTrials.gov Identifier:	NCT00662870 History of Changes
Other Study ID Numbers:	P3T06
Study First Received:	April 17, 2008
Last Updated:	January 26, 2012
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:

Cough
Diphtheria
Influenza, Human
Poliomyelitis
Tetanus
Tetany
Whooping Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations

ClinicalTrials.gov processed this record on February 12, 2012