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

2014-08-27 03:18:28 | BioPortfolio

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 children/adolescents based on European Medicines Agency's Committee for Medicinal Products for Human Use (EMEA/CHMP) criteria, and safety and tolerability.

Study Design

Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Swine-Origin Influenza A H1N1 Virus

Intervention

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

Location

Kagoshima
Japan

Status

Active, not recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:28-0400

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Medical and Biotech [MESH] Definitions

CELL LINES derived from the CV-1 cell line by transformation with a replication origin defective mutant of SV40 VIRUS, which codes for wild type large T antigen (ANTIGENS, POLYOMAVIRUS TRANSFORMING). They are used for transfection and cloning. (The CV-1 cell line was derived from the kidney of an adult male African green monkey (CERCOPITHECUS AETHIOPS).)

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A suspension of formalin-inactivated poliovirus grown in monkey kidney cell tissue culture and used to prevent POLIOMYELITIS.

The formation of one or more genetically identical organisms derived by vegetative reproduction from a single cell. The source nuclear material can be embryo-derived, fetus-derived, or taken from an adult somatic cell.

An acute, highly contagious disease affecting swine of all ages and caused by the CLASSICAL SWINE FEVER VIRUS. It has a sudden onset with high morbidity and mortality.

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