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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trivalent inactivated influenza (INTANZA) | Active Comparator | Intradermal injection |
|
| trivalent inactivated influenza (VAXIGRIP) | Active Comparator | Intramuscle injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trivalent inactivated influenza | Biological | intradermal or intramuscular injection in the deltoid area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunological end point | Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines) | with in 60 days post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety | To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group | 60 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess other related immune response | Exploratory objective to assess other related immune response (e.g. anti-neuraminidase) | 60 days |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Punnee Pitisuttithum, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, | Bangkok | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29157960 | Derived | Boonnak K, Dhitavat J, Thantamnu N, Kosoltanapiwat N, Auayporn M, Jiang L, Puthavathana P, Pitisuttithum P. Immune responses to intradermal and intramuscular inactivated influenza vaccine among older age group. Vaccine. 2017 Dec 19;35(52):7339-7346. doi: 10.1016/j.vaccine.2017.10.106. Epub 2017 Nov 20. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |