Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects
Status and phase
Completed
Phase 2
Conditions
Pandemic
Avian Influenza
Treatments
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Details and patient eligibility
About
This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.
Enrollment
405 patients
Sex
All
Ages
18 to 40 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
- Healthy subjects
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
405 participants in 8 patient groups
Concomitant alone
Experimental group
Description:
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382.
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Concomitant +Mixed
Experimental group
Description:
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Concomitant +MF59-eH5N1
Experimental group
Description:
1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Mixed
Experimental group
Description:
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Mixed and mixed
Experimental group
Description:
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Mixed+MF59-eH5N1
Experimental group
Description:
1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
MF59-eH5N1+eTIV_a
Experimental group
Description:
1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
eTIV_a+MF59-eH5N1
Experimental group
Description:
1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Treatment:
Biological: MF59-eH5N1 + eTIV_a
Biological: MF59-eH5N1
Biological: eTIV_a
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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