Safety and Immune Response of Different Pediatric Combination Vaccines.

Completed · Phase 3

Conditions studied: Diphtheria, Polio, Pertussis

In brief

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®.

Key facts

Study ID

NCT00255047

Run by

Sanofi Pasteur, a Sanofi Company

People needed

2167

Starts

2005-11-01

Expected to finish

2009-02-01

Last updated by the study team

2014-02-14

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Tuscaloosa, Alabama, United States
• Study site — Fayetteville, Arkansas, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Fountain Valley, California, United States
• Study site — Oakland, California, United States
• Study site — Oakland, California, United States
• Study site — Oakland, California, United States
• Study site — Paramount, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Bossier City, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Woburn, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Ithaca, New York, United States
• Study site — Liverpool, New York, United States
• Study site — Huber Heights, Ohio, United States
• Study site — Youngstown, Ohio, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.