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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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)
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/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
Other publications