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Study Evaluating Prevenar Vaccine in Healthy Infants

Primary Purpose

Pneumococcal Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Prevenar
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Infections focused on measuring Vaccine, Healthy Infants

Eligibility Criteria

42 Days - 100 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male and female children 2 months of age (42 to 100 days) in good health. An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study. Infants whose parent(s)/guardian(s) will be available for the entire study period. Exclusion Criteria: Hypersensitivity to any component of the vaccine, including diphtheria toxoid Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy. Other exclusions apply.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age

    Secondary Outcome Measures

    To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age

    Full Information

    First Posted
    January 11, 2006
    Last Updated
    July 28, 2009
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00276107
    Brief Title
    Study Evaluating Prevenar Vaccine in Healthy Infants
    Official Title
    An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumococcal Infections
    Keywords
    Vaccine, Healthy Infants

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Prevenar
    Primary Outcome Measure Information:
    Title
    To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
    Secondary Outcome Measure Information:
    Title
    To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    42 Days
    Maximum Age & Unit of Time
    100 Days
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female children 2 months of age (42 to 100 days) in good health. An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study. Infants whose parent(s)/guardian(s) will be available for the entire study period. Exclusion Criteria: Hypersensitivity to any component of the vaccine, including diphtheria toxoid Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy. Other exclusions apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Prevenar Vaccine in Healthy Infants

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