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

Sponsored by:	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

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

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

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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:	April 18, 2008
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

Study placed in the following topic categories:

Bacterial Infections
Haemophilus Influenzae
Whooping Cough
Cough
Diphtheria
Orthomyxoviridae Infections
Tetanus
Gram-Negative Bacterial Infections

Virus Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Clostridium Infections

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Whooping Cough
Diphtheria
Orthomyxoviridae Infections
Infection
Tetanus
Actinomycetales Infections
Gram-Negative Bacterial Infections

Bordetella Infections
Virus Diseases
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Corynebacterium Infections
Influenza, Human
Clostridium Infections

ClinicalTrials.gov processed this record on July 02, 2009