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

Novartis Vaccines200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

200

Conditions

Influenza

Interventions

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

High dose group and low dose group of adjuvanted vaccines

Eligibility

Sex: ALLMin age: 29 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Osaka pref.

Kagoshima Pref., Japan

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

AEs, vital signs, laboratory tests

Time frame: 6 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.