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
- Conditions
- Acute bronchitis in moderate to severe airway diseaseRespiratory - Other respiratory disorders / diseases
- Registration Number
- ACTRN12606000074594
- Lead Sponsor
- Hunter Immunology Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 124
Moderate to severe airway disease (FEV1 less than or equal to 50% of predicted value); at least two episodes of acute bronchitis in each of the past two years; no medical or social reason for being unable to comply with study requirements; willingness and availability to give informed consent.
Known current infection (except bronchitis); taking of antibiotics within 4 weeks prior to visit 1; participation in a clinical trial of any vaccine or immune stimulating product (except probiotics) in the past 12 months (unless known to have received placebo treatment only); participation in a clinical trial apart from that described above, in the past 3 months); pregnant, breast-feeding, or women with child-bearing potential without an effective form of contraception; any significant medical disorder which would preclude evaluation of the patient's condition (except COPD); any subject likely to withdraw or not comply with the study protocol; any other medical reason for which the investigator feels a patient should not be included.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of episodes of acute bronchitis during the study[During the study];Proportion of subjects experiencing an episode of acute bronchitis during the study[During the study];The duration of episodes of acute bronchitis during the study[During the study];The number of courses of antibiotics taken for treatment of acute episodes of bronchitis during the study[During the study]
- Secondary Outcome Measures
Name Time Method