drugset / Trial / NCT02101749

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

NCT02101749 ↗

Phase 4 Completed 221 enrolled Mahidol University
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2013-11
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Trivalent Inactivated Influenza Vaccine 0.1 ml Intramuscular
Comparator Trivalent Inactivated Influenza Vaccine 0.5 ml Intramuscular

Indications