Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Infection

Keywords

adjuvantvaccinemucosaIgAEscherichia coli Enterotoxin

Outcome Measures

Primary Outcomes (1)

Geometric mean titer changes on Day 29
Change from pre- to post-vaccination serum Geometric mean titers (GMT) of hemagglutinin inhibition (HI) antibody at Day 29(±2)
29 days

Secondary Outcomes (4)

Immunogenicity (HI titers)
29, 90 and 180 days
Immunogenicity (IgA titers)
29, 90 and 180 days
Immunogenicity (anti-LTh(αK) antibodies)
29, 90 and 180 days
Viral neutralization
29, 90 and 180 days

Study Arms (3)

30 μg of AD07010

EXPERIMENTAL

All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 30 μg of AD07010

Biological: AD07010Biological: Inactivated trivalent influenza vaccine

45 μg of AD07010

EXPERIMENTAL

All subjects in this group received 2 doses of 22.2 μg HA antigens from inactivated trivalent influenza vaccine in 45 μg of AD07010

Biological: AD07010Biological: Inactivated trivalent influenza vaccine

AD07010

ACTIVE COMPARATOR

Interventions

AD07010Biological

A protein based adjuvant

Also known as: LTh(αK), Escherichia coli heat-labile enterotoxin

30 μg of AD0701045 μg of AD07010

Inactivated trivalent influenza vaccineBiological

Inactivated trivalent seasonal influenza vaccine

Eligibility Criteria

Age20 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult male and female subjects aged between 20-70 (included) years.
Should be physically and mentally healthy and free of significant medical condition as determined by Medical history, Physical examination and Clinical judgment of the Investigator.

Sponsors & Collaborators

Advagene Biopharma Co. Ltd.
Industrylead

Study Sites (1)

Advagene Biopharma

Taipei, 104, Taiwan

Related Publications (1)

Pan SC, Hsu WT, Lee WS, Wang NC, Chen TJ, Liu MC, Pai HC, Hsu YS, Chang M, Hsieh SM. A double-blind, randomized controlled trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(alphaK): A phase II study. Vaccine. 2020 Jan 29;38(5):1048-1056. doi: 10.1016/j.vaccine.2019.11.047. Epub 2019 Dec 4.
PMID: 31812463DERIVED

MeSH Terms

Interventions

heat-labile enterotoxin, E coli

Enrollment

345 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

September 1, 2017

Actual (reported)

A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

30 μg of AD07010

45 μg of AD07010

AD07010

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

30 μg of AD07010

45 μg of AD07010

AD07010

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations