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

November 15, 2005
September 22, 2008
November 2005
December 2008   (final data collection date for primary outcome measure)
To provide information concerning the immunogenicity of Pentacel [ Time Frame: Post-dose 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00255047 on ClinicalTrials.gov Archive Site
To provide information concerning the safety of pentacel [ Time Frame: 180 days after the last vaccination. ] [ Designated as safety issue: Yes ]
Same as current
 
Safety and Immune Response of Different Pediatric Combination Vaccines.
 

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®.

 
Phase III
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Diphtheria
  • Polio
  • Pertussis
  • Biological: DAPTACEL (DTaP)
  • Biological: DTaP-IPV/Hib combined
  • Biological: DTaP-IPV and ActHIB
  • Experimental: Received DAPTACEL, ActHIB, IPOL Months 2, 4, and 6
  • Experimental: Received Pentacel at Months 2, 4, and 6
  • Experimental: Received DTaP-IPV, ActHIB at Months 2, 4, 6 and 15
  • Experimental: Received Pentacel at Months 2, 4, 6, and 15
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
2160
April 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
42 Days to 89 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255047
Medical Director, Sanofi Pasteur Inc
M5A10
Sanofi-Aventis
 
Study Director: Clinical Trials sanofi pasteur
Sanofi-Aventis
September 2008

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