Clinical trial NCT01416571: Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Monovalent Pandemic H5N1 Vaccine in Adults
Official title: Immunogenicity and Safety Study of GSK Biologicals' Monovalent Pandemic H5N1 Vaccine 1557484A in Adults Aged 18 - 64 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: H5N1
Influenza vaccine
influenza infection
GSK1557484A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 42
measure: Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
timeFrame: At Day 42
measure: Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 42
Secondary outcomes:
measure: Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 0 and Day 42
measure: Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 0 and Day 42
measure: Number of Seropositive Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 0 and Day 182
measure: Titers for Serum HI Antibodies Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 0 and Day 182
measure: Number of Seroprotected Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 0 and Day 182
measure: Number of Seroconverted Subjects Against the H5N1 Strain of Influenza Disease.
timeFrame: At Day 182
measure: Mean Geometric Increase (MGI) for the H5N1 Strain of Influenza Disease.
timeFrame: At Day 182
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day follow-up period (Days 0-6) after any vaccination
measure: Duration of Solicited Local Symptoms After Vaccination.
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day follow-up period (Days 0-6) after any vaccination
measure: Duration of Solicited General Symptoms After Vaccination.
timeFrame: During the 7-day (Days 0-6) post-vaccination period following each dose
measure: Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
timeFrame: From Day 0 to Day 84
measure: Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).
timeFrame: From Day 0 to Day 385
measure: Number of Subjects With Potential Immune Mediated Disease (s) (pIMDs).
timeFrame: From Day 0 to Day 84 and from Day 0 to Day 385
measure: Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
timeFrame: At Day 0 and Day 42
measure: Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
timeFrame: At Day 0 and Day 42
measure: Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
timeFrame: At Day 0 and Day 42
measure: Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
timeFrame: At Day 0 and Day 42
measure: Number of Subjects With Normal and Abnormal Biochemical and Haematological Parameters.
timeFrame: At Day 0 and Day 42
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: From Day 0 to Day 20 and from Day 0 to Day 84.
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Day 84 and from Day 0 to Day 385
Other outcomes:
Locations:
city: Mesa
country: United States
facility: GSK Investigational Site
state: Arizona
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.