Safety and Immune Response of Different Pediatric Combination Vaccines.

Phase 3

Completed

• Conditions: Diphtheria; Pertussis; Polio
• Interventions: Biological: DTaP-IPV and ActHIB®; Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.

• Registration Number: NCT00255047
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-15
• Study First Submitted QC: 2005-11-15
• Study First Posted: 2005-11-17
• Primary Completion: 2008-07
• Study Completion: 2009-02
• Results First Submitted: 2010-09-14
• Results First Submitted QC: 2010-10-14
• Results First Posted: 2010-11-10
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2167

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group 3: DTaP-IPV and ActHIB®	DTaP-IPV and ActHIB®	Participants will receive 3 doses of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively
Study Group 1: DAPTACEL®, ActHIB®, and IPOL®	DAPTACEL®. (DTaP), IPOL®., and ActHIB®.	Participants will receive 3 doses of DAPTACEL®, ActHIB®, and IPOL® at Months 2, 4, and 6, respectively

Primary Outcome Measures

Name	Time	Method
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.	30 Days post-dose 3 vaccination	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.
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.