| 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
|
| |
| |
| 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 |