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A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

2014-08-27 03:20:17 | BioPortfolio

Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

- To describe the immunogenicity of the candidate vaccines after each injection.

- To describe the safety of the candidate vaccines after each injection.

Description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

Monovalent Subvirion A/H1N1 Influenza vaccine, Monovalent Subvirion A/H1N1 Influenza vaccine, Normal saline solution (placebo)

Location

Miami Beach
Florida
United States
33141

Status

Active, not recruiting

Source

Sanofi-Aventis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:17-0400

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A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.

An oxyacid of chlorine (HClO) containing monovalent chlorine that acts as an oxidizing or reducing agent.

Positively charged atoms, radicals or group of atoms with a valence of plus 1, which travel to the cathode or negative pole during electrolysis.

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