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MF59-eH5N1

Phase 2

Pandemic | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Feb 3, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLED
Total Trials1
Total Enrollment405
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00481065Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult SubjectsPHASE2 COMPLETED 405Apr 1, 2007Dec 1, 2008Feb 3, 20141 Colombia
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Study Endpoints
Primary Endpoints
Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
21 days after second and third vaccinations (day 43 and day 403)

Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer \<10 for HI \[Haemagglutination Inhibition\], area ≤4 mm\^2 for SRH \[Single Radial Haemolysis\]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm\^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.

Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
21 days after second and third vaccinations (day 22 and day 43)

Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.

Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
21 days after second vaccination (day 43)

seroconversion: negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
21 days after second and third vaccinations (day 43 and day 403)

seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.

Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
21 days after second and third vaccinations (day 43 and day 403)

seroconversion (serocon.): negative pre-vaccination serum (HI titer \<10, SRH area =\<4 mm\^2)/positive post-vaccination titer (HI titer =\>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm\^2.

Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
21 days after second vaccination (day 43)

For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
21 days after second and third vaccinations (day 43 and day 403)

For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.

Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
21 days after second and third vaccinations (day 43 and day 403)

For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.

Secondary Endpoints
Number of Subjects Reporting Local and Systemic Reactions by Vaccination
21 days after second and third vaccinations (day 43 and day 403)
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
21 days after booster vaccination (day 403)
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
21 days after booster vaccination (day 403)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Concomitant aloneEXPERIMENTAL1 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.
Concomitant +MixedEXPERIMENTAL1 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
Concomitant +MF59-eH5N1EXPERIMENTAL1 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
MixedEXPERIMENTAL1 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
Mixed and mixedEXPERIMENTAL1 dose of MF59-eH5N1 mixed extemporaneously with eTIV\_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1EXPERIMENTAL1 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
MF59-eH5N1+eTIV_aEXPERIMENTAL1 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
eTIV_a+MF59-eH5N1EXPERIMENTAL1 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
Interventions
NameTypeDescription
MF59-eH5N1BIOLOGICAL -
eTIV_aBIOLOGICAL -
MF59-eH5N1 + eTIV_aBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects

Countries:Colombia
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