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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

Last updated on May 10, 2018

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Study Location
Amanzimtoti, , 4126 South Africa
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.
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Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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NCT00500357
Pfizer
Completed
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

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Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of a Subsequent Dose of 13-valent Pneumococcal Conjugate Vaccine Administered to One Group of Individuals Who Participated in Study 6115A1-500
This is a follow-up study to the core study NCT00269672 (6115A1-500). This study will further evaluate the safety, tolerability, and immunogenicity of 13-valent pneumococcal conjugate vaccine (13vPnC) when administered to subjects who have already received one dose of 13vPnC, and one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) one year later. This study will determine if a subsequent dose of 13vPnC one year later results in similar or greater immune response (body's ability to protect against disease) than that measured after the initial dose of 13vPnC.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Vaccines, Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose 13vPnC
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
105
January 2010
January 2010   (Final data collection date for primary outcome measure)
  • Previous participant of study 6115A1-500 and received 13vPnC +AlPO4 / 23vPS
  • Generally healthy male or female adults 65 years of age or older
  • Available for the duration of the trial - approximately 1 month
  • No history of severe adverse reaction associated with a vaccine

    • MMSE score less than or equal to 21 was an exclusion criteria.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT00500357
6115A1-3009
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
April 2011

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.

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1-800-718-1021

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