Who is sponsoring NCT02582047?

NCT02582047 is sponsored by Korea University Guro Hospital.

What condition does NCT02582047 study?

NCT02582047 studies Influenza, Human, Pneumococcal Infections.

What drugs are being tested in NCT02582047?

Interventions: Influenza vaccination with PPV23, Influenza vaccination with PCV13.

What is the status of NCT02582047?

NCT02582047 is currently COMPLETED.

Last reviewed 2015-10-19 · How we verify

Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients

NCT02582047 Phase 4 COMPLETED

Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

Details

Lead sponsor	Korea University Guro Hospital
Phase	Phase 4
Status	COMPLETED
Enrolment	224
Start date	2012-10
Completion	2013-01

Conditions

Influenza, Human
Pneumococcal Infections

Interventions

Influenza vaccination with PPV23
Influenza vaccination with PCV13

Primary outcomes

Seroconversion rates (A/H1N1, A/H3N2, and B) — Change from baseline titer at 4 weeks
Seroconversion: 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

Countries

South Korea