CompletedPhase 2ACTRN12606000074594

An oral killed Non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with moderate to severe airways disease: Safety and efficacy study

A multi-centre, double blind, placebo controlled, prospective study to assess safety and efficacy of orally administered killed whole cell nontypeable Haemophilus influenzae (NTHi) HI-1-164 in preventing episodes of acute bronchitis in patients with moderate to severe airway disease

Sponsor

Hunter Immunology Ltd

Enrollment

124 participants

Start Date

Mar 7, 2006

Study Type

Interventional

Conditions

Acute bronchitis in moderate to severe airway disease

Summary

This aim of this study is to determine whether an oral vaccine against non-typeable Haemophilus influenzae will reduce the number of episodes of acute bronchitis experienced by people with moderate to severe airway disease

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying: An oral killed Non-typeable Haemophilus influenzae vaccine for preventing episodes of acute bronchitis in patients with moderate to severe airways disease: Safety and efficacy study. It may be open to adults aged 18 and older. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Subjects will be randomly allocated to active tablets each containing 45mg HI-1-164-AS (inactivated non-typeable Haemophilus influenzae).

Subjects will be randomly allocated to active tablets each containing 45mg HI-1-164-AS (inactivated non-typeable Haemophilus influenzae). Study medication (2 tablets) will be taken on days 1,2,3, 29,30,31, 57, 58,59. The live phase of the study will be of 8 months duration (March-October).

Locations(1)

Australia

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ACTRN12606000074594