Safety and Immune Response of Different Pediatric Combination Vaccines.
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Polio; Pertussis
Intervention: Pentacel™ (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: sanofi pasteur
Summary
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®.
Clinical Details
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 42 Days.
Maximum age: 89 Days.
Gender(s): Both.
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 containingthe 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.
Locations and Contacts
Fayetteville, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Oakland, California, United States
Paramount, California, United States
Norwich, Connecticut, United States
Jupiter, Florida, United States
New Port Richey, Florida, United States
Marietta, Georgia, United States
Bardstown, Kentucky, United States
Bossier City, Louisiana, United States
Baltimore, Maryland, United States
Woburn, Massachusetts, United States
Omaha, Nebraska, United States
Liverpool, New York, United States
Syracuse, New York, United States
Huber Heights, Ohio, United States
Norristown, Pennsylvania, United States
Kingsport, Tennessee, United States
Amarillo, Texas, United States
Ft. Worth, Texas, United States
Galveston, Texas, United States
San Antonio, Texas, United States
Provo, Utah, United States
St George, Utah, United States
Spokane, Washington, United States
Vancouver, Washington, United States
LaCrosse, Wisconsin, United States
Marshfield, Wisconsin, United States
Additional Information
Starting date: November 2005
Last updated: September 14, 2007
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