Status:
COMPLETED
13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT01432262
Start Date
July 1 2011
End Date
December 1 2011
Last Update
January 25 2013
Active Locations (4)
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1
Instituto Mexicano de Investigación Clínica, S.A. de C.V
México, D.f., Mexico, 06700
2
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico, 14000
3
Star Medica
Morelia, Michoacán, Mexico, CP 58070
4
Hospital General de Durango
Durango, Mexico, 34000