Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00294788




Registration number
NCT00294788
Ethics application status
Date submitted
21/02/2006
Date registered
22/02/2006
Date last updated
9/01/2007

Titles & IDs
Public title
Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines
Scientific title
Phase I/II Placebo-Controlled Study of Consumption of a Probiotic on HAI Titre Following Influenza Vaccination of Healthy Adult Subjects
Secondary ID [1] 0 0
H05/123
Secondary ID [2] 0 0
ProFlu2006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percentage enhancement of the immune response to Fluvax vaccine by PCC® compared to placebo as measured by hemagglutination inhibition (HAI) titre in the serum of subjects 4 weeks after vaccination
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Increase in T cell cytokine expression; Decrease in incidence of respiratory tract illness, an improvement in general intestinal health, and a reduction in the severity of adverse side effects of the injection
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Persons must be adult men and women aged 18-49 years (have not reached 50th birthday).
* Persons must be able and willing to provide informed consent.
* Persons must be willing to receive the influenza vaccine (Fluvax®) given as an intramuscular injection.
* Persons must be willing to consume one gelatin capsule per day containing either probiotic bacteria or placebo (inactive substance) for the duration (42 days) of the study.
* Persons must be willing to provide blood specimens, each of 10 ml, collected by venepuncture.
* Persons must be willing to notify study personnel of a range of health effects by questionnaire.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any health condition for which the influenza vaccine is not recommended including: chronic diseases of the pulmonary or cardiovascular systems (including asthma); chronic metabolic diseases (including diabetes); renal dysfunction; hemoglobinopathies; immune deficiency diseases (including HIV infection) or on-going immunosuppressive therapy.
* Currently pregnant; nursing mothers; or planning a pregnancy within one month of vaccination.
* Allergy to latex, egg, or egg protein, or the antibiotics neomycin or polymyxin.
* A prior serious reaction to a vaccine, or have had Guillain-Barre syndrome.
* Received an influenza vaccine in the past.
* Received any other vaccine within one month prior to enrolment
* Are participating in another research study involving any study medication

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Good Health Solutions - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Probiomics Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ronald Penny, DSc, MD, FRACP
Address 0 0
Good Health Solutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00294788