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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Page 1 of 1 (3 locations)

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