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/ct2/show/NCT00545701




Registration number
NCT00545701
Ethics application status
Date submitted
15/10/2007
Date registered
17/10/2007
Date last updated
14/01/2014

Titles & IDs
Public title
Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults
Scientific title
Secondary ID [1] 0 0
GPA11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Orthomyxoviridae Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - A/H5N1 inactivated, split-virion influenza virus

Experimental: 1 -


Other interventions: A/H5N1 inactivated, split-virion influenza virus
0.5 mL, Intramuscular
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To provide information concerning the immunogenicity of A/H5N1 inactivated, split-virion influenza virus vaccine
Timepoint [1] 0 0
Day 42 post-vaccination 1

Eligibility
Key inclusion criteria
- Aged 18 to 60 years on day of inclusion.

- Informed Consent Form signed.

- Able to attend all scheduled visits and to comply with all trial procedures.

- For a woman, inability to bear a child or negative urine pregnancy test.

- For a woman of child-bearing potential, use of an effective method of contraception or
abstinence for at least 4 weeks prior to and at least 4 weeks after each vaccination.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Systemic hypersensitivity to any component of the vaccine or a life-threatening
reaction after previous administration of a vaccine containing the same substances
(egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and
octoxinol 9).

- Febrile illness (oral temperature >= 37.5°C) on the day of inclusion.

- Breast-feeding.

- Previous vaccination with an avian flu vaccine.

- Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks
prior to the first vaccination.

- Planned participation in another clinical trial during the present trial period.

- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such
as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or
long-term systemic corticosteroid therapy.

- Chronic illness that could interfere with trial conduct or completion (e.g. cardiac,
renal, diabetes, or auto-immune disorders).

- Current alcohol or drug abuse that may interfere with the subject's ability to comply
with trial procedures.

- Receipt of blood or blood-derived products in the past 3 months, that might interfere
with the assessment of immune response.

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

- Planned receipt of any vaccine in the 4 weeks following any trial vaccination.

- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.

- Subject deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Queensland
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Queensland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi Pasteur, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The trial is a Phase II, open-label trial in healthy subjects aged 18 to 60 years to support
the immunogenicity data from previous clinical studies.

Objectives:

- To describe the immune response 21 days after each vaccination.

- To describe the safety profiles following each vaccination.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00545701
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Monitor
Address 0 0
Sanofi Pasteur Inc.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00545701