Safety and Immune Response of Different Pediatric Combination Vaccines.
Diphtheria, Polio, Pertussis
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Study Group 1: DAPTACEL®, ActHIB®, and IPOL®
Study Group 2: Pentacel®
Study Group 3: DTaP-IPV and ActHIB®
Study Group 4: Pentacel®
Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively
Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively