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

NCT01432262

Last updated date
Study Location
Instituto Mexicano de Investigación Clínica, S.A. de C.V
Mexico, D.f., 06700, Mexico
Contact
1-800-718-1021

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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

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Advanced Information
Descriptive Information
Brief Title  ICMJE 13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Group 1
    => 65 years of age
    Intervention: Biological: vaccine-13vPnC
  • Experimental: Group 2
    50 to 64 years of age
    Intervention: Biological: vaccine-13vPnC
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2011)
324
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01432262
Other Study ID Numbers  ICMJE B1851048
6115A1-3020
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP