drugset / Trial / NCT02101749
Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Trivalent Inactivated Influenza | Vaccine | 0.1 ml | Intramuscular |
| Comparator | Trivalent Inactivated Influenza | Vaccine | 0.5 ml | Intramuscular |