MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine

NCT02225327 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2014-08-27

No results posted yet for this study

Summary

Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.

Conditions

  • Influenza, Human
  • Pneumococcal Infections

Interventions

BIOLOGICAL

Fluad alone

Fluad

BIOLOGICAL

Fluad and PPV23 on the different arms

Fluad and Prodiax

BIOLOGICAL

Fluad and PPV23 on the same arm

Fluad and Prodiax

BIOLOGICAL

PPV23 alone

Prodiax

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY
  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Hee Jin Cheong, MD, PhD · Korea University Guro Hospital

  • Joon Young Song, MD, PhD · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2013-12-31
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225327 on ClinicalTrials.gov