NCT02101749

Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.

Comparative Immune Response of Intradermal and Intramuscular Preparations of

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 221 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms: 1. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants) 2. Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.

Detailed description

The consent form will be reviewed and signed by the participant prior to any study-related procedures. Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1. A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine \[group A\] or seasonal intramuscular influenza vaccine \[group B\]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	trivalent inactivated influenza	intradermal or intramuscular injection in the deltoid area.

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-04-02
• Last updated: 2016-03-23

Locations

1 site across 1 country: Thailand