NCT05315024

Brief Summary

Aims and hypotheses to be tested: Primary objective \- To compare the IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders. Secondary objectives

  • To determine the IIV non-responder rate in healthy Hong Kong children.
  • To investigate the association between HLA molecules and IIV non-responsiveness. Hypotheses
  • The investigators hypothesize that among IIV non-responder children, the seroconversion rate after ID IIV with topical imiquimod will be significantly higher than a second IM IIV dose.
  • The investigators hypothesize that the IIV non-responder rate is approximately 5-10% in the paediatric population.
  • The investigators hypothesize that certain HLA alleles are associated with IIV non-responders.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

March 29, 2022

Last Update Submit

April 10, 2022

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

  • The IIV responses, in terms of seroconversion rates, using ID IIV with topical 5% imiquimod (IIV-Q-ID), ID influenza vaccine alone (IIV-ID), and the second dose of IM influenza vaccine (IIV-IM) among children who are IIV non-responders

    2 years

Secondary Outcomes (1)

  • The IIV non-responder rate in healthy Hong Kong children. The association between HLA molecules and IIV non-responsiveness.

    2 years

Study Arms (3)

Repeat 0.5ml IM Quadrivalent IIV (IIV-IM)

EXPERIMENTAL

Repeat 0.5ml IM Quadrivalent IIV (IIV-IM) (15micrograms haemagglutinin per vaccine strain)

Drug: Fluarix Tetra

0.1ml ID Quadrivalent IIV (IIV-ID)

EXPERIMENTAL

0.1ml ID Quadrivalent IIV (IIV-ID) (3micrograms haemagglutinin per vaccine strain)

Drug: Fluarix Tetra

0.1ml ID Quadrivalent IIV

EXPERIMENTAL

0.1ml ID Quadrivalent IIV (3micrograms haemagglutinin antigen per vaccine strain) + 5% imiquimod cream (IIV-Q-ID)

Drug: Fluarix TetraDrug: Imiquimod cream

Interventions

Fluarix TetraDRUG

Fluarix Tetra

0.1ml ID Quadrivalent IIV0.1ml ID Quadrivalent IIV (IIV-ID)Repeat 0.5ml IM Quadrivalent IIV (IIV-IM)
Imiquimod creamDRUG

Imiquimod cream

0.1ml ID Quadrivalent IIV

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 8-18 years old
  • Subjects receiving IIV influenza vaccination through the Seasonal Influenza Vaccination School Outreach Programme.

You may not qualify if:

  • Age \<8 years old to avoid the need for second dose vaccine in case the subjects have never had influenza vaccines before
  • Age \>18 years old
  • Received any forms of influenza vaccines, including the intranasal live-attenuated influenza vaccines or inactivated vaccines, in the past six months
  • Underlying chronic illnesses, including immunodeficiencies or autoimmune diseases
  • Using immunosuppressive reagents, such as long-term corticosteroids, and other steroid-sparing reagents 6 months prior to the recruitment
  • Received intravenous immunoglobulin or other blood products 3 months prior to the recruitment
  • Had upper respiratory tract infection symptoms within two weeks before the vaccination, including fever, cough, sore throat, and coryza
  • Previous allergic reactions to imiquimod, influenza vaccines, and their excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Gilbert T Chua

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilbert T Chua

CONTACT

85222554482cgt560@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 29, 2022

First Posted

April 7, 2022

Study Start

April 30, 2022

Primary Completion

September 30, 2023

Study Completion

October 30, 2023

Last Updated

April 18, 2022

Record last verified: 2022-04