Clinical trial NCT00742885: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine
Official title: Immunogenicity and Safety of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine GSK 1557484A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Immunogenicity
Safety
Pandemic Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This trial will assess the immunogenicity and safety elicited by the adjuvanted GSK Biologicals' (pre-) pandemic influenza candidate vaccine in healthy Japanese adults.


Eligibility criteria: Inclusion Criteria:

* Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive.
* Good general health as assessed by medical history and physical examination.
* 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.
* Written informed consent obtained from the subject.
* Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.

Exclusion Criteria:

* Presence of significant acute or chronic, uncontrolled medical or psychiatric illness.
* Presence or evidence of substance abuse or 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.
* Diagnosed with cancer, or treatment for cancer within 3 years.
* Presence of an axillary temperature \>= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
* Receipt of systemic glucocorticoids within 1 month of study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Administration of any registered vaccine within 30 days before study enrolment or planned administration within the first vaccination up to blood sampling at Day 42 and within 30 days prior to blood sampling at Day 182.
* Use of any investigational or non-registered product within 30 days prior to study enrolment or planned use during the study period.
* History of previous H5N1 vaccination, or history of H5N1 influenza infection.
* Receipt of any immunoglobulins and/or any blood products within 6 months of study enrolment or planned administration of any of these products during the study period.
* Any known or suspected allergy to any constituent of influenza vaccines or component used in the manufacturing process of the study vaccine, a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
* Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the time of first vaccination.
* Lactating or nursing.
* Women of child-bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments; all women will have urine pregnancy tests regardless of their status.
* Known receipt of analgesic or antipyretic medication on the day of treatment (Day 0).

Primary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
timeFrame: At Day 0 and Day 42
measure: Number of Subjects Seroconverted for H5N1 HI Antibodies
timeFrame: At Day 42
measure: HI Antibody Seroconversion Factors for H5N1 HI Antibodies
timeFrame: At Day 0 and Day 42
measure: Number of Subjects Seroprotected for H5N1 HI Antibodies
timeFrame: At Day 42
measure: Haemagglutination Inhibition (HI) Antibody Titers for the H5N1 Vaccine Strain
timeFrame: At Day 0, Day 21 and Day 182
Secondary outcomes:
measure: Number of Subjects Seroconverted for H5N1 HI Antibodies
timeFrame: At Day 21 and Day 182
measure: Seroconversion Factors for H5N1 HI Antibodies
timeFrame: At Day 21 and Day 182
measure: Number of Subjects Seroprotected for H5N1 HI Antibodies
timeFrame: At Day 0, Day 21 and Day 182
measure: Antibody Titers for Serum Anti-H5N1 Neutralising Antibodies
timeFrame: At Day 0, Day 42 and Day 182
measure: Number of Subjects Seroconverted for Serum Anti-H5N1 Neutralising Antibodies
timeFrame: At Day 42 and Day 182
measure: Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
timeFrame: At Day 0, Day 7 and Day 42
measure: Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
timeFrame: At Day 0, Day 7 and Day 42
measure: Number of Subjects With Any Biochemical and Haematological Laboratory Abnormalities
timeFrame: At Day 0, Day 7 and Day 42
measure: Number of Subjects With Any Normal or Abnormal Urine Values
timeFrame: At Day 0, Day 7 and Day 42
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day post vaccination period (Days 0-6) after any vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 7-day post vaccination period (Days 0-6) after any vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
timeFrame: During the 21-day (Days 0-20) following vaccination
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
timeFrame: From Day 0 to Day 83 following vaccination
measure: Number of Subjects Reporting Any Medically-significant Conditions (MSCs)
timeFrame: During the 182-day (Days 0-181) post-vaccination period
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
timeFrame: During the entire study period (Day 0 to Day 181)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nagai H, Ikematsu H, Tenjinbaru K, Maeda A, Drame M, Roman FP. A phase II, open-label, multicentre study to evaluate the immunogenicity and safety of an adjuvanted prepandemic (H5N1) influenza vaccine in healthy Japanese adults. BMC Infect Dis. 2010 Nov 25;10:338. doi: 10.1186/1471-2334-10-338.