Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

Novartis

Status and phase: Completed; Phase 3; Phase 2

Conditions: Influenza

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00996138

V110_05

Details and patient eligibility

About

This study is to identify the preferred vaccine dosage (of antigen and adjuvant) and schedule (one or two administrations) of the cell-derived H1N1sw monovalent vaccine in healthy adults based on EMEA/CHMP criteria, and safety & tolerability.

Enrollment: 200 patients

Sex: All

Ages: 29 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese adults aged 20 to 60 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 to study start
• Administration of any other vaccines within 4 weeks prior to enrollment expect for seasonal influenza vaccines within 1 week
• History of progressive or severe neurological disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Arm 1

Other group

Description:

Dose ranging

Treatment:

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

Arm 2

Other group

Description:

Dose ranging

Treatment:

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