Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01967368|
Recruitment Status : Unknown
Verified October 2013 by Dr. Chan Tuen Ching, The University of Hong Kong.
Recruitment status was: Recruiting
First Posted : October 22, 2013
Last Update Posted : October 22, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Drug: Intanza Drug: Vaxigrip||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||June 2015|
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
- Change from baseline in neutralization antibody titre against influenza [ Time Frame: day 0 (baseline), day 21 and day 180 of vaccination ]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 ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|