Influenza Vaccines, Elderly
Conditions
Keywords
influenza, adjuvanted vaccine, immunogenicity, elderly, safety
Brief summary
To compare the immunogenicity, cellular immune response, and safety between adjuvanted (aIIV4) and non-adjuvanted (IIV4) seasonal influenza vaccines in the Taiwanese elderly population with chronic medical conditions.
Detailed description
Annual influenza vaccination is the most important and cost-effective intervention in reducing the impact of influenza, and a key component of the WHO response and preparedness efforts for influenza of pandemic potential. Reduced effectiveness of conventional egg-based vaccination was observed among risk group, such as elderly and people on with chronic medical conditions, which may result from their impaired immunogenicity. WHO, as well as ACIP of the USA, Europe, and Australia suggested adjuvanted influenza vaccines as one of alternatives for those people, which could decrease the disease burden significantly in several analyses. An adjuvanted commercial vaccine has been approved in Taiwan recently, but the local data of safety and effectiveness analysis is limited. This 1-year randomized control trial is designed to estimate the safety and effectiveness of adjuvanted influenza vaccine among Asian elderly people when compared to non-adjuvanted vaccines.
Interventions
DRUGadjuvanted
adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
DRUGnon-adjuvanted
non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 65 years or above * Presence of at least 1 chronic medical condition associated with increased risk of complicated influenza, including hypertension, chronic obstructive pulmonary disease (group A, B, E), asthma, congestive heart failure (ACC/AHA stage A, B, C, D), coronary arterial disease, diabetes mellitus, chronic liver disease (Child-Pugh score A, B, C) or chronic kidney disease (stage 1\~4), neuromuscular disorders, hematological or solid organ malignancies, recipient of hematopoietic stem cell transplantation or solid organ transplantation.
Exclusion criteria
* Contraindications to influenza vaccination including history of severe adverse event after vaccination, such as anaphylaxis or Guillain-Barré Syndrome, or a severe bleeding tendency * Prior receipt of influenza vaccination during the current flu season. * Determination by the Principal Investigator (PI) that the participant is ineligible for enrollment based on clinical assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29. | Measured through Day 29 | The seroconversion rate (SCR) measured by the change in hemagglutination inhibition (HI) titer against the vaccine strains in serum between Day 1 (pre-vaccination) and Day 29. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7) | Measured through Day 361 | The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7) |
| Incidence of severe adverse reactions within 28 days after immunization. | Measured through Day 28 | Incidence of severe adverse reactions within 28 days after immunization. |
| Incidence of laboratory-confirmed influenza during the study period. | Measured through Day 361 | Incidence of laboratory-confirmed influenza during the study period. |
| Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period. | Measured through Day 361 | Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period. |
Countries
Taiwan
Contacts
CONTACTJann-Tay Wang Clinical Professor, M. D., Ph.D.
CONTACTUn-In Wu Clinical Associate Professor, M. D.
Outcome results
None listed