Status:
COMPLETED
Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Influenza
Streptococcus Pneumoniae
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident ...
Detailed Description
This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University...
Eligibility Criteria
Inclusion
- Adults aged ≥60 years who signed the informed consent
Exclusion
- Previous pneumococcal vaccine recipients
- Egg allergy
- History of serious adverse event after vaccination,
- any acute disease or infection
- History of neurological symptoms or signs
- Impairment of immune function or immunosuppressant use
- Bleeding diathesis
- Fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1195 Patients enrolled
Trial Details
Trial ID
NCT02215863
Start Date
September 1 2014
End Date
March 1 2015
Last Update
April 1 2015
Active Locations (3)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Hallym University Gangnam Sacred Hospita
Seoul, South Korea
3
Catholic University Medical College, St. Vincent's Hospital
Suwon, South Korea