Immunogenicity and Safety of Pandemic Influenza Vaccines in Adults Aged 18 - 49 Years Old
Immunogenicity and Safety Study of GSK Biologicals' Cell Culture Derived Pandemic Influenza Vaccines GSK2590066A and GSK2592984A Administered to Healthy Adults 18 - 49 Years Old
1 other identifier
interventional
521
1 country
4
Brief Summary
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedStudy Start
First participant enrolled
November 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2012
CompletedMay 10, 2017
May 1, 2017
9 months
October 28, 2010
May 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Immunogenicity with respect to components of the investigational vaccine Day 0
Day 0
Immunogenicity with respect to components of the investigational vaccine Day 42
Day 42
Occurrence of Grade 3 injection site pain
During a 7-day follow-up period (Day 0 to 6) after any vaccination
Secondary Outcomes (10)
Occurrence of each solicited local symptom
During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of each solicited general symptom
During a 7-day follow-up period (Day 0 to 6) after any vaccination
Occurrence of unsolicited adverse events (AEs)
Within 21 days (Day 0 to 20) after any vaccination
Occurrence of AEs with medically attended visits (MAEs)
During the entire study period (from Day 0 to Month 12)
Occurrence and relationship to vaccination of (potential) immune mediated diseases (pIMDs)
During the entire study period (from Day 0 to Month 12)
- +5 more secondary outcomes
Study Arms (6)
Group A
EXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Group B
EXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2592984A vaccine at a 21-day interval.
Group C
PLACEBO COMPARATORSubjects will receive 2 doses of a placebo at a 21-day interval.
Group D
EXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.
Group E
EXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2340274A vaccine at a 21-day interval.
Group F
EXPERIMENTALSubjects will receive 2 doses of a formulation of GSK2340273A vaccine at a 21-day interval.
Interventions
Intramuscular injection, two doses
Intramuscular injection, two doses
Intramuscular injection, two doses
Intramuscular injection, two doses
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Male and female adults, 18-49 years of age at the time of the first vaccination.
- Satisfactory baseline medical assessment by history and physical examination.
- Safety laboratory test results within the parameters specified in the protocol.
- Access to a consistent means of telephone contact
- Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of first vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
You may not qualify if:
- Medical history of physician-confirmed infection with an H5N1 virus.
- Increased risk of occupational exposure to H5N1 influenza viruses.
- Previous vaccination at any time with an H5N1 vaccine, or with an oil-in water adjuvanted influenza vaccine.
- Planned administration of an adjuvanted influenza vaccine or an H5N1 pandemic vaccine during the entire study period.
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
- Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Evidence of current substance abuse, including alcohol, by medical history.
- Presence of a temperature \>= 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first dose.
- Diagnosed with cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
- Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin, outside of 24 hours prior to dosing, are eligible. Persons receiving prophylactic antiplatelet medications.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
Stockbridge, Georgia, 30281, United States
GSK Investigational Site
Lenexa, Kansas, 66219, United States
GSK Investigational Site
Austin, Texas, 78705, United States
Related Publications (1)
Schuind A, Segall N, Drame M, Innis BL. Immunogenicity and Safety of an EB66 Cell-Culture-Derived Influenza A/Indonesia/5/2005(H5N1) AS03-Adjuvanted Vaccine: A Phase 1 Randomized Trial. J Infect Dis. 2015 Aug 15;212(4):531-41. doi: 10.1093/infdis/jiv091. Epub 2015 Feb 25.
PMID: 25722291DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 8, 2010
Study Start
November 29, 2010
Primary Completion
September 6, 2011
Study Completion
August 20, 2012
Last Updated
May 10, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.