Estimate the Safety and Effectiveness of Adjuvanted Influenza Vaccine Among Asian Elderly People When Compared to Non-adjuvanted Vaccines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: adjuvanted, non-adjuvanted.
- Who it may be relevant to
- Registry conditions: Influenza Vaccines, Elderly. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study on the Immunogenicity and Safety of Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in the Elderly
Overview
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
- Drug adjuvanted
adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions - Drug non-adjuvanted
non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions
Primary outcome measures
- 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. [Time frame: Measured through Day 29]
Secondary outcome measures (4)
- The geometric mean titer (GMT), seroprotection rate (SPR), cellular immune responses on Day1, Day 29 (±3), Day 181 (±7), and Day 361 (±7) [Time frame: Measured through Day 361]
- Incidence of severe adverse reactions within 28 days after immunization. [Time frame: Measured through Day 28]
- Incidence of laboratory-confirmed influenza during the study period. [Time frame: Measured through Day 361]
- Incidence of emergency department visits and hospitalizations related to respiratory illness, all-cause mortality during the study period. [Time frame: Measured through Day 361]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06676644 · 202409030MIND