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

Tracking Information

First Received Date ^ICMJE

April 17, 2008

Last Updated Date

August 18, 2009

Start Date ^ICMJE

May 2001

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00662870 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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:

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.

Detailed Description

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Diphtheria
Tetanus
Whooping Cough
Polio
Haemophilus Influenzae Type B

Intervention ^ICMJE

Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
Biological: DTaP-IPV/Hib

Study Arms / Comparison Groups

Experimental: Lot 1
Experimental: Lot 2
Experimental: Lot 3

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1941

Completion Date

January 2004

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

42 Days to 84 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00662870

Responsible Party

Medical Monitor, Sanofi Pasteur Inc.

Study ID Numbers ^ICMJE

P3T06

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Sanofi Pasteur, Inc.

Information Provided By

Sanofi-Aventis

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP