Status:
COMPLETED
Safety and Immune Response of Different Pediatric Combination Vaccines.
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Polio
Eligibility:
All Genders
42-89 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 intramuscular (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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
2167 Patients enrolled
Trial Details
Trial ID
NCT00255047
Start Date
November 1 2005
End Date
February 1 2009
Last Update
February 14 2014
Active Locations (36)
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1
Tuscaloosa, Alabama, United States, 35401
2
Fayetteville, Arkansas, United States, 72703
3
Jonesboro, Arkansas, United States, 72401
4
Little Rock, Arkansas, United States, 72205