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Trial record 1 of 2 for:    NCT00269672
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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00269672
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : August 5, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 23, 2005
Last Update Posted Date August 5, 2010
Study Start Date  ICMJE September 2005
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2006)
Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
  • Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
  • Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by OPA).
  • Safety and tolerability of each 13vPnC formulation and 23vPS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2006)
  • Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
  • Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2005)
  • Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
  • Safety and tolerability of 23vPS 12 months after 13vPnC
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
Official Title  ICMJE A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization
Brief Summary There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine
Study Arms  ICMJE Not Provided
Publications * Juergens C, de Villiers PJ, Moodley K, Jayawardene D, Jansen KU, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine formulations with and without aluminum phosphate and comparison of the formulation of choice with 23-valent pneumococcal polysaccharide vaccine in elderly adults: a randomized open-label trial. Hum Vaccin Immunother. 2014;10(5):1343-53. doi: 10.4161/hv.27998. Epub 2014 Feb 27.

*   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
Actual Enrollment  ICMJE
 (submitted: August 4, 2010)
915
Original Enrollment  ICMJE
 (submitted: December 21, 2005)
900
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female adults 65 years of age and older.
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
  • Expected to be available for the duration of the trial (up to approximately 13 months).

Exclusion Criteria:

  • Received previous immunization with 23vPS.
  • Serious chronic disorders including metastatic malignancy
  • Known or suspected hypersensitivity to any vaccine or vaccine components
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
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 NCT00269672
Other Study ID Numbers  ICMJE 6115A1-500
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 August 2010

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