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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00269672
Collaborator
(none)
915
Enrollment
17
Duration (Months)

Study Details

Study Description

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
  • Biological: 13-valent Pneumococcal Conjugate Vaccine
 Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2005
Actual Primary Completion Date :
Feb 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00269672
Other Study ID Numbers:
  • 6115A1-500
First Posted:
Dec 23, 2005
Last Update Posted:
Aug 5, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
vaccine
Additional relevant MeSH terms:
Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Aug 5, 2010