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13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

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NCT01432262

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Instituto Mexicano de Investigación Clínica, S.A. de C.V
Mexico, D.f., 06700 Mexico
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female older than 50 years of age

- Eligibility must be determined by medical history, physical exam and clinical judgment

- Able to complete an electronic diary

- Available for duration of study

- Negative pregnancy test for subjects in group 2 age 50 to 64 years

- Practice abstinence or use reliable birth control if age is 50 to 64 years

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

- History of allergic reaction to any vaccine

- Previous vaccination with licensed or experimental pneumococcal vaccine

- S. pneumonia infection within past 5 years before investigational product
administration

- Known or suspected immunodeficiency or received treatment including cytotoxic agents
or systemic corticosteroids, serious chronic disorder such as malignancy cancer

- Receipt of plasma products or immunoglobulins within 60 days

- Bleeding conditions or diathesis

- Receipt of investigational product within 28 days before study entry

- Other severe acute or chronic medical or psychiatric condition

NCT01432262
Pfizer
Completed
13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

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13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
A Phase 3, Open Label, Single Arm, Multicenter, Trial to Assess The Safety, Tolerability And Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine In Healthy Adults Aged => 50 Years of Age Who Are Naive To 23-Valent Pneumococcal Polysaccharide Vaccine in Mexico.
The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
Biological: vaccine-13vPnC
Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
Other Name: 13-valent pneumococcal conjugate vaccine
  • Experimental: Group 1
    => 65 years of age
    Intervention: Biological: vaccine-13vPnC
  • Experimental: Group 2
    50 to 64 years of age
    Intervention: Biological: vaccine-13vPnC
Tinoco JC, Juergens C, Ruiz Palacios GM, Vazquez-Narvaez J, Enkerlin-Pauwells HL, Sundaraiyer V, Pathirana S, Kalinina E, Gruber WC, Scott DA, Schmoele-Thoma B. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ? 50 years of age in Mexico. Clin Vaccine Immunol. 2015 Feb;22(2):185-92. doi: 10.1128/CVI.00711-14. Epub 2014 Dec 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
324
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female older than 50 years of age
  • Eligibility must be determined by medical history, physical exam and clinical judgment
  • Able to complete an electronic diary
  • Available for duration of study
  • Negative pregnancy test for subjects in group 2 age 50 to 64 years
  • Practice abstinence or use reliable birth control if age is 50 to 64 years

Exclusion Criteria:

  • History of allergic reaction to any vaccine
  • Previous vaccination with licensed or experimental pneumococcal vaccine
  • S. pneumonia infection within past 5 years before investigational product administration
  • Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
  • Receipt of plasma products or immunoglobulins within 60 days
  • Bleeding conditions or diathesis
  • Receipt of investigational product within 28 days before study entry
  • Other severe acute or chronic medical or psychiatric condition
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01432262
B1851048
6115A1-3020
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

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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Contact

[email protected]



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