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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
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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).

Condition or disease Intervention/treatment Phase
Vaccines, Pneumococcal Conjugate Vaccine Biological: 13-valent Pneumococcal Conjugate Vaccine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 915 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2005
Primary Completion Date : February 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.

Secondary Outcome Measures :
  1. Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
  2. Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269672

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00269672     History of Changes
Other Study ID Numbers: 6115A1-500
First Posted: December 23, 2005    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: August 2010

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs