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Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or Female aged 70 years or older.

- Documented vaccination with 1 dose of 23vPS at least 5 years previous.

- Healthy.

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

- Receipt of more than one dose of 23vPS prior to enrollment.

- History of severe adverse reaction to a vaccine.

- Immunodeficiency.

NCT00546572
Pfizer
Completed
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

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Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
A Phase 3, Randomized, Active-Controlled, Modified Double-Blind Trial, Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) Compared To A 23-Valent Pneumococcal Polysaccharide (23vPS) Vaccine in Ambulatory Elderly Individuals Aged 70 Years And Older Who Received One Dose of 23vPS At Least 5 Years Prior To Study Enrollment
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago. It will also evaluate the safety, tolerability and immunogenicity to a dose of 13vPnC 1 year after the initial dose of study vaccine.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: 13 valent Pneumococcal Conjugate Vaccine
    0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
  • Biological: 23vPS
    0.5-mL dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5-mL dose 13vPnC will be administered into the deltoid muscle at year 1
  • Experimental: 1
    Receives 13vPnC at year 0 and 13vPnC at year 1
    Intervention: Biological: 13 valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Receives 23vPS at year 0 and 13vPnC at year 1
    Intervention: Biological: 23vPS
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
938
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female aged 70 years or older.
  • Documented vaccination with 1 dose of 23vPS at least 5 years previous.
  • Healthy.

Exclusion Criteria:

  • Receipt of more than one dose of 23vPS prior to enrollment.
  • History of severe adverse reaction to a vaccine.
  • Immunodeficiency.
Sexes Eligible for Study: All
70 Years and older   (Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden,   United States
 
 
NCT00546572
6115A1-3005
B1851024
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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