Safety and Immune Response of Different Pediatric Combination Vaccines.

Study Overview
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Brief Summary
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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®.

Official Title
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Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers

Conditions
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Diphtheria, Polio, Pertussis

Intervention / Treatment
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* Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
* Biological: Pentacel®: DTaP-IPV/Hib combined
* Biological: DTaP-IPV and ActHIB®
* Biological: Pentacel®: DTaP-IPV/Hib combined


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 89 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group 1: DAPTACEL®, ActHIB®, and IPOL®<br>Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively | Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.<br>* 0.5 mL, Intramuscular<br>* Other names: ActHIB®;|
| Experimental: Study Group 2: Pentacel®<br>Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively | Biological: Pentacel®: DTaP-IPV/Hib combined<br>* 0.5 mL, Intramuscular<br>* Other names: Pentacel®;|
| Experimental: Study Group 3: DTaP-IPV and ActHIB®<br>Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively | Biological: DTaP-IPV and ActHIB®<br>* 0.5 mL, Intramuscular<br>* Other names: ActHIB®;|
| Experimental: Study Group 4: Pentacel®<br>Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively | Biological: Pentacel®: DTaP-IPV/Hib combined<br>* 0.5 mL, Intramuscular<br>* Other names: Pentacel®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. | Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer. | 30 Days post-dose 3 vaccination | 
| Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) |  | 30 Days post-dose 3 vaccination | 
| Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. |  | 30 Days post-dose 3 vaccination. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Whooping cough, Filamentous Haemagglutinin, Fimbriae Types 2 and 3;, Pertactin, Diphtheria, Tetanus, Poliovirus Types 1, 2, and 3.