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Safety and Immune Response of Different Pediatric Combination Vaccines.
This study is ongoing, but not recruiting participants.
First Received: November 15, 2005   Last Updated: September 22, 2008   History of Changes
Sponsor: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00255047
  Purpose

The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, IPOL®, and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.


Condition Intervention Phase
Diphtheria
Polio
Pertussis
Biological: DAPTACEL (DTaP)
Biological: DTaP-IPV/Hib combined
Biological: DTaP-IPV and ActHIB
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • To provide information concerning the immunogenicity of Pentacel [ Time Frame: Post-dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide information concerning the safety of pentacel [ Time Frame: 180 days after the last vaccination. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2160
Study Start Date: November 2005
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Received DAPTACEL, ActHIB, IPOL Months 2, 4, and 6
Biological: DAPTACEL (DTaP)
0.5 mL, Intramuscular
2: Experimental
Received Pentacel at Months 2, 4, and 6
Biological: DTaP-IPV/Hib combined
0.5 mL, Intramuscular
3: Experimental
Received DTaP-IPV, ActHIB at Months 2, 4, 6 and 15
Biological: DTaP-IPV and ActHIB
0.5 mL, Intramuscular
4: Experimental
Received Pentacel at Months 2, 4, 6, and 15
Biological: DTaP-IPV/Hib combined
0.5 mL, Intramuscular

  Eligibility

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

Inclusion Criteria:

  • Aged >=42 days and <=89 days on the day of inclusion
  • Born at full term of pregnancy (>=36 weeks)
  • Informed consent form signed by the parent(s) or other legally authorized representative(s) before the 1st study related procedure
  • Vaccination with a hepatitis B vaccine at least 30 days before inclusion
  • Able to attend all scheduled visits and to comply with all trial procedures(i.e., access to a phone)
  • Provide blood sample prior to Dose 1
  • Parent or legal representative willing to take rectal temperatures after each vaccination.

Exclusion Criteria:

  • Participation in another clinical trial in the 4 weeks preceding the (first)trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
  • Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s)
  • Chronic illness that could interfere with trial conduct or completion
  • Received blood or blood-derived products since birth
  • Any vaccination in the 2 weeks preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination. Flu vaccine could be administered only 2 weeks after any trial vaccination
  • Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b Hib)-conjugate, poliovirus, or pneumococcal conjugate vaccines
  • Coagulation disorder contraindicating IM vaccination
  • Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion)
  • Developmental delay or neurological disorder
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255047

  Hide Study Locations
Locations
United States, Arkansas
Fayetteville, Arkansas, United States
Little Rock, Arkansas, United States
United States, California
Fountain Valley, California, United States
Oakland, California, United States
Paramount, California, United States
United States, Connecticut
Norwich, Connecticut, United States
United States, Florida
Jupiter, Florida, United States
New Port Richey, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Kentucky
Bardstown, Kentucky, United States
United States, Louisiana
Bossier City, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Woburn, Massachusetts, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
Liverpool, New York, United States
Syracuse, New York, United States
United States, Ohio
Huber Heights, Ohio, United States
United States, Pennsylvania
Norristown, Pennsylvania, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Amarillo, Texas, United States
Ft. Worth, Texas, United States
Galveston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Provo, Utah, United States
St George, Utah, United States
United States, Washington
Spokane, Washington, United States
Vancouver, Washington, United States
United States, Wisconsin
LaCrosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Clinical Trials sanofi pasteur
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi Pasteur Inc ( Medical Director )
Study ID Numbers: M5A10
Study First Received: November 15, 2005
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00255047     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Pertussis
Whooping cough
Filamentous Haemagglutinin
Fimbriae Types 2 and 3;
Pertactin
Diphtheria
Tetanus
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:
Bacterial Infections
Bordetella Infections
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections
Whooping Cough
Diphtheria
Infection
Actinomycetales Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on November 27, 2009