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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/NCT00296829




Registration number
NCT00296829
Ethics application status
Date submitted
24/02/2006
Date registered
27/02/2006
Date last updated
14/01/2014

Titles & IDs
Public title
Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Given by an Alternate Route in the Elderly
Scientific title
Secondary ID [1] 0 0
GID16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthomyxoviridae Infection 0 0
Influenza 0 0
Myxovirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Inactivated, split-virion influenza vaccine

Other interventions: Inactivated, split-virion influenza vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Aged 60 to 85 years on the day of inclusion

- Informed consent form signed

- Able to attend all scheduled visits and to comply with all trial procedures.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Systemic hypersensitivity to egg proteins, chick proteins, or any of the vaccine
components, in particular, neomycin, formaldehyde, and octoxinol 9, or history of a
life-threatening reaction to the trial vaccine or a vaccine containing the same
substances

- Febrile illness (oral temperature >= 37.5°C equivalent rectal temperature >= 38.0°C)
on the day of inclusion

- Any vaccination or participation in another clinical trial in the four weeks preceding
the first trial vaccination

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

- Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer
chemotherapy or radiation therapy within the preceding six months, or long-term
systemic corticosteroids therapy

- Chronic illness at a stage that could interfere with trial conduct or completion

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

- Blood or blood-derived products received in the past three months

- Vaccination planned in the four weeks following the first trial vaccination

- Previous vaccination against influenza (in the previous six months) with the trial
vaccine or another vaccine

- 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
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 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
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Carina Heights
Recruitment hospital [3] 0 0
- Inala
Recruitment hospital [4] 0 0
- Kippa-Ring
Recruitment hospital [5] 0 0
- Victoria
Recruitment hospital [6] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
QLD 4152 - Carina Heights
Recruitment postcode(s) [3] 0 0
QLD 4077 - Inala
Recruitment postcode(s) [4] 0 0
QLD 4021 - Kippa-Ring
Recruitment postcode(s) [5] 0 0
3079 - Victoria
Recruitment postcode(s) [6] 0 0
3128 - Victoria
Recruitment postcode(s) [7] 0 0
3144 - Victoria
Recruitment postcode(s) [8] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Dunedin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
All marketed influenza vaccines are injected by the intramuscular route. This study will test
whether an influenza vaccine is effective when injected by other route than into the muscle.
In order to prove this, the amount of antibodies in the blood will be measured before and
after vaccination. In addition, the safety of both influenza vaccines will be tested by
evaluating all serious reactions occurring after vaccination. The vaccine injected in this
study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip).

Primary Objective:

To demonstrate and compare the immune response of two dosages of influenza vaccine
administered by an alternate route to the intramuscular administration of the vaccine.

Secondary Objectives:

- To compare the immune response 21 days after vaccination between each investigational
group versus intramuscular group for each influenza strain.

- To describe the safety profile after the vaccination in each study group

- To describe the compliance of the two dosages of the vaccine administered by the
alternate route with the European Medicine Agency.

Observational Objectives:

- To describe the safety profile during the 21-day period following an intramuscular
revaccination in each group and the possibility of any reaction at the first injection
site.

- To describe the pain at the injection site with a Visual Analog Scale and the
acceptability of the injection using a questionnaire in each group.

- To describe the leakage appearing at the injection site immediately after the alternate
route injection and to explore the relationship with immunogenicity.

- To evaluate the cellular mediated immune response in a subset of subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00296829
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Sanofi Pasteur, a Sanofi Company
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/NCT00296829