Status:
COMPLETED
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
42-89 years
Phase:
PHASE3
Brief Summary
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 infa...
Detailed Description
This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- 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.
- Exclusion Criteria :
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
1167 Patients enrolled
Trial Details
Trial ID
NCT00772928
Start Date
October 1 2003
End Date
November 1 2006
Last Update
February 1 2012
Active Locations (23)
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1
Montgomery, Alabama, United States, 36106
2
Fayetteville, Arkansas, United States, 72703
3
Jonesboro, Arkansas, United States, 72401
4
Little Rock, Arkansas, United States, 72205