Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults
Recruitment status was Recruiting
Influenza is associated with significant morbidity and mortality. Institutionalized older adults (age>65) is the group associated with highest risk of complications. Influenza vaccines are the cornerstone of influenza prevention but one systematic review has found that there is no statistically significant difference against laboratory confirmed influenza. A major reason is immune senescence in older adults which result in weaker response towards vaccines when compared with young adults. Intradermal administration of vaccine has been suggested to improve immune response due to the abundance of immunostimulatory cells, such as dendritic cells in the dermis. Intradermal administration of influenza vaccine has been shown to have comparable or superior efficacy compared with intramuscular administration in the >60-year old population and the rates of adverse events post-vaccination were also comparable between them. The immunogenicity of intradermal administration has also been shown to be better in immunocompromised patients, including community dwelling older adults. In addition, intradermal vaccination has good acceptability and safety profile in different countries, so it has been licensed in Hong Kong and worldwide. However, there is little study regarding the efficacy of intradermal vaccination of influenza in institutionalized older adults, investigators therefore would like to perform a prospective, randomized study to compare the safety and immunogenicity between conventional full dose intramuscular immunization and full dose intradermal immunization of the trivalent influenza vaccine in institutionalized older adults.
The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective as full-dose standard intramuscular injection in terms of seroconversion and seroprotection rate in institutionalized older adults. Finding of this study will be important in the vaccination of institutionalized older adults and immunocompromised patients as intradermal vaccine may induce a better immune response against influenza infection.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults|
- Change from baseline in neutralization antibody titre against influenza [ Time Frame: day 0 (baseline), day 21 and day 180 of vaccination ] [ Designated as safety issue: No ]Neutralization antibody titre against the 3 influenza viruses are tested 3 times at day 0, day 21 and day 180 of vaccination for comparison. The titer of neutralization antibody is defined as the maximum dilution of serum at which the percentage of cytopathic effect is less than or equal to 50%.
- Adverse effects [ Time Frame: day 0 and day 7 of vaccination ] [ Designated as safety issue: Yes ]Adverse effects due to vaccination from day 0 to day 7 will be recorded. Adverse effects boardly divided into local and systemic. Local adverse effect include swelling, erythema, pruritis, pain. Systemic adverse effect include fever, malaise, myalgia
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
intradermal injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Intanza, single dose injection
Principal Investigator would be responsible for injecting the intradermal vaccine in a sterile technique.
Other Name: Intanza, intradermal trivalent influenza vaccine
Active Comparator: Vaxigrip
intramuscular injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Vaxigrip, single dose injection
Principal Investigator would be responsible for injecting the intrmuscular vaccine in a sterile technique.
Other Name: Vaxigrip, intramuscular trivalent influenza vaccine
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967368
|Contact: Tuen Ching Chan, MBBSemail@example.com|
|Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority||Recruiting|
|Hong Kong, China|
|Contact: Tuen Ching Chan, MBBS 85266816077 firstname.lastname@example.org|
|Principal Investigator: Tuen Ching Chan, MBBS|
|Principal Investigator:||Tuen Ching Chan, MBBS||The University of Hong Kong, Department of Medicine, Queen Mary Hospital|