Immunogenicity and safety of conventional influenza vaccine in patients with type 2 diabetes

Efficacy and effectiveness of influenza vaccine in Korean adults

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0001423

Enrollment

236

Registered

2015-03-24

Start date

2012-10-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : standard dose trivalent subunit inactivated intramuscular vaccine (Agripal® S1, Novartis Vaccines and Diagnostics S. R. L., Italy) in diabetes patients and non-di

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetes and healthy adults aged 19 and over Written informed consent obtained from the subject

Exclusion criteria

Exclusion criteria: known allergy to egg, presentation of any febrile illness =37.5°C on the day of vaccination, any history of hypersensitivity reaction to previous influenza vaccination, any other vaccinations within the past one month, use of immunosuppressive agent, recipient of blood product or immunoglobulins during the previous three months, and any other conditions that might interfere with the study results.

Design outcomes

Primary

Measure	Time frame
Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Agripal Vaccine Strains;Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Agripal Vaccine Strains ;Geometric Mean Titers (GMTs) of Haemagglutination Inhibition (HI) Antibodies Against Agripal Vaccine Strains	—

Secondary

Measure	Time frame
Number of Subjects With Solicited Local and General Symptoms After Administration of Agripal	—

Countries

Korea, Republic of

Contacts

Public ContactYu Bin Seo

Hallym University Medical Center-Kangnam

yubinseo@gmail.com+82-2-829-5531

Outcome results