Status:
COMPLETED
The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Va...
Eligibility Criteria
Inclusion
- Without fever for 72 hours prior to vaccination
Exclusion
- Prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine
- Known or suspected to be immunocompromised
- Functional or anatomic asplenia
- History of autoimmune disease
- Evidence of dementia or cognitive impairment
- Use of any immunosuppressive therapy
- Received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine
- Received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine
- Received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine
- Received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine
- History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease
- Received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine
Key Trial Info
Start Date :
March 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2013
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT01513551
Start Date
March 13 2012
End Date
February 15 2013
Last Update
December 13 2018
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