Who is sponsoring NCT02225327?

NCT02225327 is sponsored by Korea University Guro Hospital.

What condition does NCT02225327 study?

NCT02225327 studies Influenza, Human, Pneumococcal Infections.

What drugs are being tested in NCT02225327?

Interventions: Fluad alone, Fluad and PPV23 on the different arms, Fluad and PPV23 on the same arm, PPV23 alone.

What is the status of NCT02225327?

NCT02225327 is currently COMPLETED.

Last reviewed 2014-08-26 · How we verify

Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination

NCT02225327 Phase 4 COMPLETED

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.

Details

Lead sponsor	Korea University Guro Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	224
Start date	2013-10
Completion	2014-01

Conditions

Influenza, Human
Pneumococcal Infections

Interventions

Fluad alone
Fluad and PPV23 on the different arms
Fluad and PPV23 on the same arm
PPV23 alone

Primary outcomes

Seroconversion rates (A/H1N1, A/H3N2, and B) — Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of \<1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10