Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine

Completed · Phase 3

Conditions studied: Diphtheria, Tetanus, Whooping Cough, Polio, Haemophilus Influenzae Type b

In brief

This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.

Key facts

Study ID

NCT00662870

Run by

Sanofi

People needed

1941

Starts

2001-05-01

Expected to finish

2004-01-01

Last updated by the study team

2012-01-31

Who can join

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

You may qualify if…

• Healthy infants 2 months of age.
• Infants with at least 37 weeks of gestation at delivery.
• Signed informed consent from parent or guardian.
• Able to attend the scheduled visits and to comply with the study procedure.
• Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.

You may not qualify if…

• Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
• Known or suspected hypersensitivity to any component of the study vaccine to be administered.
• Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
• Known HIV-positive mother.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay or neurologic disorders.
• Chronic medical, congenital, developmental or surgical disease.
• Participation in any other experimental vaccine trial.
• Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
• Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine

Where it is running

• Study site — Fayetteville, AR 72703, Arkansas, United States
• Study site — Jonesboro, AR 72401, Arkansas, United States
• Study site — Little Rock, AR 72211, Arkansas, United States
• Study site — Fountain Valley, CA 92708, California, United States
• Study site — Englewood, CO 80112, Colorado, United States
• Study site — Norwich, CT 06360, Connecticut, United States
• Study site — Orlando, FL 32856, Florida, United States
• Study site — Marietta, GA 30062, Georgia, United States
• Study site — Chicago, IL 60614, Illinois, United States
• Study site — Bardstown, KY 40004, Kentucky, United States
• Study site — Bossier City, LA 71111, Louisiana, United States
• Study site — Bridgeton, MO 63044, Missouri, United States
• Study site — Rochester, NY 14620, New York, United States
• Study site — Chapel Hill, NC 27514, North Carolina, United States
• Study site — Portland, OR 97201, Oregon, United States
• Study site — Norristown, PA 19401, Pennsylvania, United States
• Study site — Pittsburgh, PA 15213, Pennsylvania, United States
• Study site — Pittsburgh, PA 15241, Pennsylvania, United States
• Study site — Kingsport, TN 37664, Tennessee, United States
• Study site — Austin, TX 78758, Texas, United States
• Study site — Fort Worth, TX 76107, Texas, United States
• Study site — San Antonio, TX 78205, Texas, United States
• Study site — Provo, UT 84604, Utah, United States
• Study site — Spokane, WA 99220, Washington, United States
• Study site — LaCrosse, WI 54601, Wisconsin, United States

Full record on ClinicalTrials.gov

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