Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Completed · Phase 3

Conditions studied: Diphtheria, Tetanus, Haemophilus Infection, Pertussis, Polio

In brief

This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™ Primary Objective - Stage I: To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®). Primary Objective - Stage II: To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.

Key facts

Study ID

NCT00772928

Run by

Sanofi

People needed

1167

Starts

2003-10-01

Expected to finish

2006-11-01

Last updated by the study team

2012-02-01

Who can join

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

You may qualify if…

• Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
• Infants with at least 36 weeks of gestation at delivery.
• Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
• Able to attend the scheduled visits and to comply with the study procedures.
• Parent or legal guardian willing to take rectal temperatures during the infant series.
• Parent or legal guardian has access to a telephone.
• Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
• Able to obtain at least 1.5 mL of blood sample prior to Dose 1.

You may not qualify if…

• Clinically significant findings on review of systems (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 Human Immunodeficiency Virus (HIV)-positive mother or child.
• Personal or immediate family history of congenital immune deficiency.
• Developmental delay or neurologic disorder.
• Chronic medical, congenital, or developmental disease.
• Participation in any other clinical trial.
• 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.
• Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.

Where it is running

• Study site — Montgomery, 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 — Rolling Hills Estate, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Bardstown, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Kansas City, Missouri, United States
• Study site — Brooklyn, New York, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Fort Worth, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Layton, Utah, United States
• Study site — Spokane, Washington, United States
• Study site — Vancouver, Washington, United States
• Study site — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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