Safety and Immune Response of Different Pediatric Combination Vaccines.

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Polio; Pertussis

Treatments: Biological: Pentacel®: DTaP-IPV/Hib combined; Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.; Biological: DTaP-IPV and ActHIB®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00255047

M5A10

Details and patient eligibility

About

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®.

Enrollment: 2,167 patients

Sex: All

Ages: 42 to 89 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,167 participants in 4 patient groups

Study Group 1: DAPTACEL®, ActHIB®, and IPOL®

Experimental group

Description:

Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively

Treatment:

Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.

Study Group 2: Pentacel®

Experimental group

Description:

Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively

Treatment:

Biological: Pentacel®: DTaP-IPV/Hib combined

Biological: Pentacel®: DTaP-IPV/Hib combined

Study Group 3: DTaP-IPV and ActHIB®

Experimental group

Description:

Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively

Treatment:

Biological: DTaP-IPV and ActHIB®

Study Group 4: Pentacel®

Experimental group

Description:

Participants will receive 3 doses of Pentacel® at Months 2, 4, and 6, respectively

Treatment:

Biological: Pentacel®: DTaP-IPV/Hib combined

Biological: Pentacel®: DTaP-IPV/Hib combined