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Monovalent A/H1N1 influenza vaccine

Phase 3

Pandemic Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Feb 11, 2020

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
RandomizedCONTROLLEDBiomarker
Total Trials4
Total Enrollment3,002
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00971542Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of AgePHASE3 COMPLETED 778 — — Sep 1, 2009Jul 1, 2011Oct 12, 20115 Belgium, Chile +3
NCT00970177Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of AgePHASE3 COMPLETED 812 — — Aug 1, 2009Mar 1, 2011Dec 1, 20163 Belgium, Germany +1
NCT00971100Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of AgePHASE3 COMPLETED 752 — — Aug 1, 2009Aug 1, 2011Dec 1, 20163 Belgium, Dominican Republic +1
NCT00971906Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of AgePHASE3 COMPLETED 660 — — Aug 1, 2009Apr 1, 2011Feb 11, 20204 Belgium, Germany +1
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Study Endpoints
Primary Endpoints
To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents
43 days after first vaccination
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults.
43 days after first vaccination
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
43 days after first vaccination
Secondary Endpoints
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria.
3 weeks after booster vaccination
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria
3 weeks after booster vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
low dose of antigen + low dose of adjuvantEXPERIMENTAL -
high dose of antigen + high dose of adjuvantEXPERIMENTAL -
high dose of antigenEXPERIMENTAL -
Interventions
NameTypeDescription
Monovalent A/H1N1 influenza vaccineBIOLOGICALThis trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.
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Eligibility Criteria
Age Range6 Months — 17 Years
SexALL
Healthy VolunteersYes
Study Sites5

Inclusion Criteria: 1. Males and females 6 months of age to 17 years of age on the day of enrollment; 2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable; 3. Individuals in good health; 4. Subjects, subject's parents or leg...

Countries:BelgiumChileDominican RepublicGermanyNetherlandsSwitzerland
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