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Virus Therapy
Safety and Immune Response Study of GSK Biologicals' Influenza Virus Vaccine 1388442A Compared With Fluarix
Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 90-day (days 0-89) post-vaccination period
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine \[Fluarix\] in healthy adults.
Eligible Conditions
- Influenza
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the 90-day (days 0-89) post-vaccination period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 90-day (days 0-89) post-vaccination period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Geometric Mean Fold-rise (GMFR) in 3 Strains of Influenza Disease.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
+7 moreSide effects data
From 2009 Phase 1 trial • 200 Patients • NCT0069370648%
Pain
24%
Headache
19%
Fatigue
15%
Muscle aches
1%
Abortion spontaneous
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK 1388442A Group
Fluarix Group
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: GSK 1388442A GroupExperimental Treatment1 Intervention
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of GSK 1388442A vaccine at Day 0. The GSK 1388442A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Group II: Fluarix GroupActive Control1 Intervention
Subjects aged 18 to 49 years of age at the time of vaccination received 1 dose of Fluarix® vaccine at Day 0. The Fluarix® vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trivalent influenza vaccine GSK 138842A
2008
Completed Phase 1
~200
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,815 Previous Clinical Trials
8,383,990 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,609 Previous Clinical Trials
6,145,359 Total Patients Enrolled