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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

NCT01626820 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2018-09-07

Study results available
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Summary

This study is designed to test the immunogenicity in terms of Hemagglutination Inhibition (HI) antibodies against each of the three vaccine influenza strains and reactogenicity and safety of Fluviral® containing the influenza strains recommended for the 2012-2013 season.

Conditions

Interventions

BIOLOGICAL

Fluviral®

1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-19
Primary Completion
2012-08-10
Completion
2012-08-10

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01626820 on ClinicalTrials.gov