Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults

NCT ID: NCT01059617

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-09
• Study Completion Date: 2011-10-21

Brief Summary

This study is designed to characterize the safety and immunogenicity of a' pandemic influenza (H1N1) candidate vaccine GSK2340274A in adults 19 to 40 years who have never received influenza vaccination.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Flulaval/Arepanrix Group

subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.

Group Type: EXPERIMENTAL

GSK Biologicals' FluLaval®

Intervention Type: BIOLOGICAL

Intramuscular injection

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A

Intervention Type: BIOLOGICAL

Intramuscular injections

Flulaval/Unadjuvanted Arepanrix Group

subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.

Group Type: EXPERIMENTAL

GSK Biologicals' FluLaval®

Intervention Type: BIOLOGICAL

Intramuscular injection

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A

Intervention Type: BIOLOGICAL

Intramuscular injections

Placebo/Arepanrix Group

subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.

Group Type: EXPERIMENTAL

Placebo (saline)

Intervention Type: BIOLOGICAL

Intramuscular injection

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A

Intervention Type: BIOLOGICAL

Intramuscular injections

Placebo/Unadjuvanted Arepanrix Group

subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.

Group Type: EXPERIMENTAL

Placebo (saline)

Intervention Type: BIOLOGICAL

Intramuscular injection

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A

Intervention Type: BIOLOGICAL

Intramuscular injections

Interventions

GSK Biologicals' FluLaval®

Intramuscular injection

Intervention Type: BIOLOGICAL

Placebo (saline)

Intramuscular injection

Intervention Type: BIOLOGICAL

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340274A

Intramuscular injections

Intervention Type: BIOLOGICAL

GSK Biologicals' investigational H1N1 Influenza Vaccine - GSK2340273A

Intramuscular injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
• Written informed consent obtained from the subject.
• Male or female adults, 19-40 years of age at the time of the first vaccination.
• Body weight of at least 110 pounds (49.9 kg).
• Safety laboratory tests results within the parameters specified by protocol.
• Satisfactory baseline medical assessment by physical examination (stable health status with no exclusionary conditions). Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrollment.
• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.
• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy, or post-menopause.
• 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 pregnancy test on the day of 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

• Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine
• A medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
• Prior receipt at any time of any seasonal influenza vaccine.
• Planned administration of any vaccine not foreseen by the study protocol (including any influenza vaccine other than the study vaccine) between Days 0 and the Day 164 phlebotomy.
• Administration of any licensed vaccine within 30 days before the first study vaccine dose.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Receipt of systemic glucocorticoids (e.g., prednisone ≥ 0.5 mg/kg/day, or ≥ 10 mg/day [whichever is less] for more than 14 consecutive days) within one month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within six months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.
• Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• History of anemia.
• Presence of a temperature ≥ 38.0ºC (≥100.4ºF), (oral temperature assessment preferred), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination
• Diagnosed with cancer, or treatment for cancer, within 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. (No laboratory testing is required.)
• 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 vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within six weeks of receipt of any vaccine.
• Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to any vaccine.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-HCG) test result prior to first vaccination.
• Lactating or nursing women.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Milford, Massachusetts, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

Countries

United States

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

113483

Identifier Type: -

Identifier Source: org_study_id