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Trial record 1 of 1 for:    NCT00276107
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Study Evaluating Prevenar Vaccine in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00276107
Recruitment Status : Completed
First Posted : January 12, 2006
Last Update Posted : July 29, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE January 11, 2006
First Posted Date  ICMJE January 12, 2006
Last Update Posted Date July 29, 2009
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00276107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2006)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Prevenar Vaccine in Healthy Infants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: Prevenar
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 11, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 100 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276107
Other Study ID Numbers  ICMJE 0887X-101446
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP