NCT00996138

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

A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Japanese Adult Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 29 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted cell-derived, inactivated novel swine origin A/H1N1 monovalent subunit influenza virus vaccine	High dose group and low dose group of adjuvanted vaccines

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-10-16
• Last updated: 2016-12-01

Locations

1 site across 1 country: Japan