Influenza, Human Clinical Trial
Official title:
Comparative Immune Response of Intradermal and Intramuscular Preparations of
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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