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

Last updated on May 11, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Conjugate Vaccine Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Received previous immunization with 23vPS.

- Serious chronic disorders including metastatic malignancy

- Known or suspected hypersensitivity to any vaccine or vaccine components

NCT00269672
Pfizer
Completed
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

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Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
915
February 2007
February 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00269672
6115A1-500
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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