Influenza
Conditions
Keywords
H1N1, Pandemrix, Fluarix, Influenza
Brief summary
The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control. This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.
Interventions
BIOLOGICALPandemrixTM
One dose intramuscular injection
BIOLOGICALFluarixTM/ Influsplit SSW® 2010/2011
One dose intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug and alcohol abuse. * Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to be enrolled in the Groups A or B OR subjects who have not been previously vaccinated with a vaccine against the pandemic H1N1 strain at all, to be enrolled in group C. * A male or female 18 years and above at the time of enrolment. * Written informed consent obtained from the subject. * Healthy subjects or free of acute aggravation of the health status as established by physical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. * Administration of any influenza vaccine within 6 month prior to vaccination in this study. * Presence of 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. * Presence of an axillary temperature ≥ 37.5ºC, or acute symptoms greater than mild severity on the scheduled date of first vaccination. * Diagnosed with cancer, or treatment for cancer, within the past 3 years. * Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. * Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period.. * Any administration of a long-acting immune-modifying drug (within 3 months before study start, or a planned administration during the study period. * Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment 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 vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. * An acute evolving neurological disorder or history of Guillain-Barré syndrome. * Clinically or virologically confirmed influenza infection within 6 months preceding the study start. * Administration of any vaccines within 30 days before vaccination. * Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions from study inclusion up to 2 months after completion of the vaccination series. * Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years | 21 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Solicited Local and General Symptoms | During 7 days (Day 0 - Day 6) after vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events | During 31 days (Day 0 - Day 30) after vaccination |
| Number of Subjects Reporting Serious Adverse Events | During the whole study period (Day 0 - Day 182) |
| Potential Immune Mediated Diseases | During the whole study period (Day 0 - Day 182) |
| Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years | At Days 0, 7 and 182 |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pandemrix Group Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix. | 4 |
| Fluarix Group Subjects previously vaccinated with Pandemrix received one dose of Fluarix. | 3 |
| Control Group Subjects not previously vaccinated with Pandemrix received one dose of Fluarix. | 0 |
| Total | 7 |
Baseline characteristics
| Characteristic | Pandemrix Group | Fluarix Group | Total |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 9.5 | 55.3 years STANDARD_DEVIATION 18.8 | 58.7 years STANDARD_DEVIATION 13.16 |
| Gender Female | 3 subjects | 2 subjects | 5 subjects |
| Gender Male | 1 subjects | 1 subjects | 2 subjects |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 2 / 3 | 0 / 0 |
| serious Total, serious adverse events | 1 / 4 | 0 / 3 | 0 / 0 |
Outcome results
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
Time frame: 21 days after vaccination
Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Secondary
Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years
Time frame: At Days 0, 7 and 182
Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Secondary
Number of Subjects Reporting Serious Adverse Events
Time frame: During the whole study period (Day 0 - Day 182)
Population: The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemrix Group | Number of Subjects Reporting Serious Adverse Events | 1 subjects |
| Fluarix Group | Number of Subjects Reporting Serious Adverse Events | 0 subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During 31 days (Day 0 - Day 30) after vaccination
Population: The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pandemrix Group | Number of Subjects Reporting Unsolicited Adverse Events | 0 subjects |
| Fluarix Group | Number of Subjects Reporting Unsolicited Adverse Events | 2 subjects |
Secondary
Potential Immune Mediated Diseases
Time frame: During the whole study period (Day 0 - Day 182)
Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Secondary
Solicited Local and General Symptoms
Time frame: During 7 days (Day 0 - Day 6) after vaccination
Population: This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.