Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults

NCT ID: NCT01416571

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-12
• Study Completion Date: 2012-09-28

Brief Summary

This trial will assess the immunogenicity and safety of GSK Biologicals' vaccine GSK1557484A, prepared from old concentrated monobulk material, in adults aged 18 to 64 years, when administered up to 5 years following production.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Influenza A (H5N1) Group

Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.

Group Type: EXPERIMENTAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intervention Type: BIOLOGICAL

Intramuscular (IM), two doses

Interventions

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Intramuscular (IM), two doses

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol.
• A male or female 18 to 64 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Stable general health as established by medical history and clinical examination before entering into the study.
• Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
• 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 pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception for 2 months after completion of the vaccination series.

Exclusion Criteria

• Previous vaccination at any time with an H5N1 vaccine.
• Use of any investigational or non-registered product other than the study vaccine 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 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.
• Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on the scheduled date of first dose.
• 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.
• Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within 6 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 3 months before first study vaccination 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, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Administration of an inactivated or a live, attenuated 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.
• Planned administration of any vaccine(s) not foreseen by the study protocol through completion of the Day 42 visit.
• Any known or suspected allergy to any constituent of influenza vaccines, or history of severe reaction to a previous influenza vaccination.
• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first study vaccine dose.
• Lactating or nursing women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 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

Mesa, Arizona, United States

Countries

United States

References

Godeaux O, Izurieta P, Madariaga M, Drame M, Li P, Vaughn DW. Immunogenicity and safety of AS03A-adjuvanted H5N1 influenza vaccine prepared from bulk antigen after stockpiling for 4 years. Vaccine. 2015 Apr 27;33(18):2189-95. doi: 10.1016/j.vaccine.2014.07.062. Epub 2014 Jul 30.

Reference Type: DERIVED

PMID: 25090645 (View on PubMed)

Study Documents

Document Type: Study Protocol

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: Dataset Specification

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: Individual Participant Data Set

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

Related Links

https://www.clinicalstudydatarequest.com

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

Other Identifiers

112691

Identifier Type: -

Identifier Source: org_study_id