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Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
This study has been completed.
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00772928
  Purpose

This study is designed to evaluate in a controlled manner, evaluate the effect of Prevnar® on the immune responses of Pentacel™

Primary Objective - Stage I:

To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).

Primary Objective - Stage II:

To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.


Condition Intervention Phase
Diphtheria
Tetanus
Haemophilus Infection
Pertussis
Polio
Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T
Phase III

MedlinePlus related topics: Diphtheria Tetanus Whooping Cough
Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines 1,2-Dimethyl-3-hydroxypyrid-4-one
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title: Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immune response of Pentacel™. [ Time Frame: 28 to 48 days post 3rd and 4th vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety of Pentacel™. [ Time Frame: 0-7 days post 3rd and 4th vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 1167
Study Start Date: October 2003
Study Completion Date: November 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Pentacel™ concurrently administered with Prevnar®
Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T
0.5 mL, Intramuscular
2: Experimental
Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
Biological: Liquid HCPDT-mIPV to reconstitute lyophilized ActHIB®: PRP-T
0.5 mL, Intramuscular

Detailed Description:

This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®.

Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

  Eligibility

Ages Eligible for Study:   42 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Healthy infants 2 months (>=42 days and <=89 days) of age.
  • Infants with at least 36 weeks of gestation at delivery.
  • Must have received 1 dose of HepB vaccine (with that dose at least 15 days before the administration of study vaccines).
  • Able to attend the scheduled visits and to comply with the study procedures.
  • Parent or legal guardian willing to take rectal temperatures during the infant series.
  • Parent or legal guardian has access to a telephone.
  • Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
  • Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

Exclusion Criteria :

  • Clinically significant findings on review of systems (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 or child.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay or neurologic disorder.
  • Chronic medical, congenital, or developmental disease.
  • Participation in any other clinical trial.
  • Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
  • Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772928

Locations
United States, Alabama
Montgomery, Alabama, United States, 36106
United States, Arkansas
Little Rock, Arkansas, United States, 72205
Fayetteville, Arkansas, United States, 72703
Jonesboro, Arkansas, United States, 72401
United States, California
Rolling Hills Estate, California, United States, 90274
Fountain Valley, California, United States, 92708
Oakland, California, United States, 94612
United States, Connecticut
Norwich, Connecticut, United States, 06360
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Missouri
Kansas City, Missouri, United States, 64112
United States, New York
Brooklyn, New York, United States, 11201
United States, Pennsylvania
Norristown, Pennsylvania, United States, 19401
Pittsburgh, Pennsylvania, United States, 15241
United States, Texas
Fort Worth, Texas, United States, 76107
Austin, Texas, United States, 78745
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78745
United States, Utah
Layton, Utah, United States, 84041
United States, Washington
Vancouver, Washington, United States, 98864
Spokane, Washington, United States, 99220
United States, Wisconsin
Lacrosse, Wisconsin, United States, 54601
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Sanofi Pasteur Inc. ( Medical Monitor )
Study ID Numbers: M5A07
Study First Received: October 13, 2008
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00772928  
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.

Study placed in the following topic categories:
Haemophilus Infections
Bacterial Infections
Haemophilus influenzae
Deferiprone
Whooping Cough
Cough
Diphtheria
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Poliomyelitis
Influenza, Human
Clostridium Infections

Additional relevant MeSH terms:
Bordetella Infections
Pasteurellaceae Infections
Corynebacterium Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009