- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00269672
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
August 4, 2010 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
915
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
December 21, 2005
First Submitted That Met QC Criteria
December 21, 2005
First Posted (Estimate)
December 23, 2005
Study Record Updates
Last Update Posted (Estimate)
August 5, 2010
Last Update Submitted That Met QC Criteria
August 4, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6115A1-500
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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