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

This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccines GSK2590066A and GSK2340273A in healthy adults 18 - 49 years old.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: GSK Biologicals' investigational vaccine GSK2590066A; Biological: GSK Biologicals' investigational vaccine GSK2592984A; Other: Placebo; Biological: GSK Biologicals' investigational vaccine GSK2340274A; Biological: GSK Biologicals' investigational vaccine GSK2340273A

• Study Type: Interventional
• Enrollment (Actual): 521
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • GSK Investigational Site
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • GSK Investigational Site
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • GSK Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Administration of an inactivated seasonal influenza vaccine within 14 days before the first study vaccine dose, or of any other vaccine(s) not foreseen by the study protocol within 30 days before the first study vaccine dose. The administration of live attenuated trivalent seasonal influenza virus vaccine (LAIV) is allowed.
• Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit. The administration of LAIV is allowed.
• Any known or suspected allergy to any constituent of influenza vaccines or to latex, or history of severe reaction to a previous influenza vaccination.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to the first study vaccine dose.
• Lactating or nursing women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.	Biological: GSK Biologicals' investigational vaccine GSK2590066A; Intramuscular injection, two doses
Experimental: Group B; Subjects will receive 2 doses of a formulation of GSK2592984A vaccine at a 21-day interval.	Biological: GSK Biologicals' investigational vaccine GSK2592984A; Intramuscular injection, two doses
Placebo Comparator: Group C; Subjects will receive 2 doses of a placebo at a 21-day interval.	Other: Placebo; Intramuscular injection, two doses; Other Names: Control
Experimental: Group D; Subjects will receive 2 doses of a formulation of GSK2590066A vaccine at a 21-day interval.	Biological: GSK Biologicals' investigational vaccine GSK2590066A; Intramuscular injection, two doses
Experimental: Group E; Subjects will receive 2 doses of a formulation of GSK2340274A vaccine at a 21-day interval.	Biological: GSK Biologicals' investigational vaccine GSK2340274A; Intramuscular injection, two doses
Experimental: Group F; Subjects will receive 2 doses of a formulation of GSK2340273A vaccine at a 21-day interval.	Biological: GSK Biologicals' investigational vaccine GSK2340273A; Intramuscular injection, two doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
Occurrence and relationship to vaccination of serious adverse events (SAEs)	During the entire study period (from Screening to Month 12)
Occurrence of adverse pregnancy outcomes	During the entire study period (from Day 0 to Month 12)
Clinical safety laboratory abnormalities	At Days 7, 28 and at Month 6.
Immunogenicity with respect to components of the investigational vaccine in terms of hemagglutinin Inhibition (HI) antibodies	At Days 0, 21, and 42 and Months 6 and 12
Immunogenicity with respect to components of the investigational vaccine in terms of microneutralization (MN) antibodies	Days 0, 21, and 42 and Months 6 and 12

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2010
• Primary Completion (Actual): September 6, 2011
• Study Completion (Actual): August 20, 2012

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: November 4, 2010
• First Posted (Estimate): November 7, 2010

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; H5N1; Pandemic
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 114371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Statistical Analysis Plan
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Informed Consent Form
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 114371
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register