A Trial to Test the Response to Different Vaccination Reg... | NCT00695669

NCT00695669

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Influenza A (H5N1) 1 Group	Experimental	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.	Biological: Influenza A (H5N1) Virus Monovalent Vaccine
Influenza A (H5N1) 2 Group	Experimental	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 14. The vaccine was administered intramuscularly in the deltoid region of the arm.	Biological: Influenza A (H5N1) Virus Monovalent Vaccine
Influenza A (H5N1) 3 Group	Experimental	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 7. The vaccine was administered intramuscularly in the deltoid region of the arm.	Biological: Influenza A (H5N1) Virus Monovalent Vaccine
Influenza A (H5N1) 4 Group	Experimental	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. The vaccine was administered intramuscularly in the deltoid region of the arm.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza A (H5N1) Virus Monovalent Vaccine	Biological	Two doses administered intramuscularly (IM), the first in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.	At Day 14 post Dose 2
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	Titers are presented as geometric mean titers (GMTs). The Confidence Interval for this outcome was 98.75%.	At Day 0 and at Day 14 post Dose 2
Number of Seroprotected Subjects Against 3 Strains the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.	At Day 0 and at Day 14 post Dose 2

Secondary Outcomes

Measure	Description	Time Frame
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	Titers are presented as geometric mean titers (GMTs). This outcome only covers results for the Pumarix 1 Group.	At Days 0, 21, 28, 35, 42 and 182.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female 18-64 years old at the time of the first vaccination.
Written informed consent obtained from the subject.
Good general health as established by medical history and clinical examination before entering into the study.
Access to a consistent means of telephone contact.
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness 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 evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically 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.
Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may be enrolled, but other histological types of skin cancer are exclusionary.
Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may be enrolled.
Presence of an oral temperature ≥37.8ºC, 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 enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any vaccines within 30 days before study enrollment or during the 30 days following the last test article dose. Subjects who receive such immunizations on an emergent basis after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity.
Previous administration of any H5N1 vaccine.
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 182 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
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 a previous influenza vaccine.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to either 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. Note: all women will have urine pregnancy tests regardless of their status.
Known receipt of analgesic or antipyretic medication on the day of treatment with specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Greater Sudbury	Ontario	P3E 6C3	Canada
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
21791660	Derived	Lasko B, Reich D, Madan A, Roman F, Li P, Vaughn D. Rapid immunization against H5N1: a randomized trial evaluating homologous and cross-reactive immune responses to AS03(A)-adjuvanted vaccination in adults. J Infect Dis. 2011 Aug 15;204(4):574-81. doi: 10.1093/infdis/jir328.

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

ID	Type	URL	Comment
111626	Statistical Analysis Plan	View IPD

Arm/Group Information

ID	Title	Description
FG000	Influenza A (H5N1) 1 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.
FG001	Influenza A (H5N1) 2 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 14. The vaccine was administered intramuscularly in the deltoid region of the arm.
FG002	Influenza A (H5N1) 3 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 7. The vaccine was administered intramuscularly in the deltoid region of the arm.
FG003	Influenza A (H5N1) 4 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. The vaccine was administered intramuscularly in the deltoid region of the arm.

ID	Title	Description
BG000	Influenza A (H5N1) 1 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.
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal hemagglutination inhibition (HI) titer less than (<) 1:10 and a post-vaccination (at Day 14 post Dose 2) reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a four-fold increase in post-vaccination (at Day 14 post Dose 2) titer.

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and post-vaccination HI titer results for the A/Indonesia/5/05 virus.

Posted

Number

Subjects

At Day 14 post Dose 2

ID	Title	Description
OG000	Influenza A (H5N1) 1 Group

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Influenza A (H5N1) 1 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.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections