Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
NCT ID: NCT00772928
Last Updated: 2012-02-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1167 participants
INTERVENTIONAL
2003-10-31
2006-11-30
Brief Summary
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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®.
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Detailed Description
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Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pentacel™ concurrently with Prevnar®
Participants had Pentacel™ concurrently administered with Prevnar®
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Pentacel™ staggered schedule with Prevnar®
Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Interventions
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Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
42 Days
89 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Layton, Utah, United States
Spokane, Washington, United States
Vancouver, Washington, United States
La Crosse, Wisconsin, United States
Montgomery, Alabama, United States
Fayetteville, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Fountain Valley, California, United States
Oakland, California, United States
Rolling Hills Estate, California, United States
Norwich, Connecticut, United States
Bardstown, Kentucky, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
Brooklyn, New York, United States
Norristown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Austin, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Countries
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Related Links
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Related Info
Other Identifiers
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M5A07
Identifier Type: -
Identifier Source: org_study_id
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