NCT06676644

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Nov 2024Dec 2027

First Submitted

Initial submission to the registry

November 4, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

November 21, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

November 4, 2024

Last Update Submit

February 22, 2026

Conditions

Influenza VaccinesElderly

Keywords

influenzaadjuvanted vaccineimmunogenicityelderlysafety

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Secondary Outcomes (4)

  • 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

  • Incidence of severe adverse reactions within 28 days after immunization.

    Measured through Day 28

  • Incidence of laboratory-confirmed influenza 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.

    Measured through Day 361

Study Arms (2)

adjuvanted

EXPERIMENTAL

adjuvanted (aIIV4) influenza vaccine

Drug: adjuvanted

non-adjuvanted

ACTIVE COMPARATOR

non-adjuvanted (IIV4) influenza vaccine

Drug: non-adjuvanted

Interventions

adjuvantedDRUG

adjuvanted (aIIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

adjuvanted
non-adjuvantedDRUG

non-adjuvanted (IIV4) influenza vaccine in the Taiwanses elderly with chronic medical conditions

non-adjuvanted

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

GBP510 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Central Study Contacts

Jann-Tay Wang Clinical Professor, M. D., Ph.D.

CONTACT

+886-2-2312-3456wangjt1124@ntuh.gov.tw

Un-In Wu Clinical Associate Professor, M. D.

CONTACT

+886-2-2312-3456uninwu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 4, 2024

First Posted

November 6, 2024

Study Start

November 21, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Locations

TW(1)