Phase 3
N=2,167
Safety and Immune Response of Different Pediatric Combination Vaccines.
Diphtheria · Polio · Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT00255047 ↗Enrolled (actual)
2,167
Serious AEs
3.1%
Results posted
Nov 2010
Primary outcome: Primary: Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. — 98; 99; 99; 99 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DAPTACEL®. (DTaP), IPOL®., and ActHIB®. (Biological); Pentacel®: DTaP-IPV/Hib combined (Biological); DTaP-IPV and ActHIB® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. |
98; 99; 99; 99; 86; 96 | — |
| PRIMARY Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) |
89; 92; 92; 92; 54; 75 | — |
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. |
66.48; 96.8; 116.86; 97.8; 22.51; 53.0 | — |
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®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT00255047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.