Recent Updates
Recently added Catalysts

Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Novartis AG|Last Updated: Dec 1, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine · 2 trials · 2 indications

Phase 2 2
NCT01000207Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric SubjectsSwine-Origin Influenza A H1N1 Virus
COMPLETED123 Analytics
NCT00996138Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult SubjectsInfluenza
COMPLETED200 Analytics
PHASE2COMPLETED
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Pediatric Subjects
Swine-Origin Influenza A H1N1 VirusUnlock trial analytics
PHASE2COMPLETED
Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Seroprotection, GMRs and Seroconversion rate at Weeks 0, 3 and 6
6 weeks

Secondary Endpoints

AEs, vital signs, laboratory tests
6 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDose ranging
2EXPERIMENTALDose ranging
Arm 1OTHERDose ranging
Arm 2OTHERDose ranging

Interventions

NameTypeDescription
Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccineBIOLOGICALHigh dose group and low dose group of adjuvanted vaccines
Unlock Study Design Details

Eligibility Criteria

Age Range6 Months to 19 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Japanese aged 6 months to 19 years Exclusion Criteria: * History of anaphylaxis, serious vaccine reactions, hypersensitivity to vaccine viral proteins or excipients * Administration of adjuvanted influenza vaccine or suspected influenza disease within 3 month prior t...

Countries:Japan
Unlock Eligibility Criteria