Influenza
Conditions
Keywords
Influenza, GSK 1557484A vaccine
Brief summary
The purpose of this study is to evaluate the safety and immune response of two-doses of GSK Biologicals' candidate influenza vaccine GSK 1557484A with or without adjuvant in adults. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study has five core arms and the stratification is based on site and age. In addition, there are 4 possible contingent groups of which 2 will be studied based on an analysis concerning immunogenicity performance at Day 42 in core groups above.
Interventions
BIOLOGICALPumarix™
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.
BIOLOGICALPandemrix ™
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female adults 18 to 64 years of age at time of first vaccination, inclusive. * Good general health as assessed by medical history and physical examination. * Access to a consistent means of telephone contact * 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 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. * Blood pressure abnormalities * 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 enroll, but other histologic 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 enroll. * Presence of an oral temperature ≥ 37.8º 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 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 non-influenza vaccines within 30 days before study enrollment or during the study period. * 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 study period. * Receipt of any immunoglobulins and/or any blood products within 3 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. * Known pregnancy or a positive urine beta-human chorionic gonadotropin (ß-hCG) test result prior to dosing on Study Days 0 or 21. * Lactating or nursing. * Women of child bearing potential who lack a history of reliable contraceptive practices. * Known receipt of analgesic or antipyretic medication on the day of treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any Serious Adverse Events (SAEs). | From Day 0 to 182 | A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Solicited Local Symptoms. | Within the 7-day follow-up period (Days 0-6) after any vaccination | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm). |
| Number of Subjects With Solicited General Symptoms. | Within the 7-day follow-up period (Days 0-6) after any vaccination | Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination. |
| Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | From Day 0 to 182 | A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus. |
| Number of Subjects With Unsolicited Adverse Events (AEs). | During the 21-day follow-up period (Days 0-20) after vaccination. | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Day 42 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day. |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Day 42 | Titers are presented as geometric mean titers (GMTs). |
| Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Day 42 | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Days 21 and 182 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day. |
| Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Days 21 and 182 | GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0. |
| Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Days 0, 21 and 182 | A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day. |
| Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | At Day 21 and Day 182 | Titers are presented as geometric mean titers (GMTs). |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pumarix Formulation 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 78 |
| Pumarix Formulation 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 152 |
| Pumarix Formulation 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 151 |
| Pandemrix Formulation A Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 151 |
| Pandemrix Formulation B Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 148 |
| Pumarix Formulation 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 50 |
| Pumarix Formulation 5 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one). | 50 |
| Total | 780 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 | 1 | 3 | 4 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | Pumarix Formulation 1 Group | Pumarix Formulation 2 Group | Pumarix Formulation 3 Group | Pandemrix Formulation A Group | Pandemrix Formulation B Group | Pumarix Formulation 4 Group | Pumarix Formulation 5 Group | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.5 Years STANDARD_DEVIATION 12.85 | 38.1 Years STANDARD_DEVIATION 12.1 | 39.0 Years STANDARD_DEVIATION 12.59 | 38.7 Years STANDARD_DEVIATION 11.25 | 38.7 Years STANDARD_DEVIATION 12.2 | 39.2 Years STANDARD_DEVIATION 12.21 | 39.9 Years STANDARD_DEVIATION 13.18 | 38.8 Years STANDARD_DEVIATION 12.22 |
| Sex: Female, Male Female | 45 Participants | 83 Participants | 87 Participants | 100 Participants | 78 Participants | 32 Participants | 24 Participants | 449 Participants |
| Sex: Female, Male Male | 33 Participants | 69 Participants | 64 Participants | 51 Participants | 70 Participants | 18 Participants | 26 Participants | 331 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 78 | 137 / 152 | 132 / 151 | 146 / 151 | 131 / 148 | 48 / 50 | 42 / 50 |
| serious Total, serious adverse events | 0 / 78 | 2 / 152 | 1 / 151 | 2 / 151 | 1 / 148 | 1 / 50 | 0 / 50 |
Outcome results
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 titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Time frame: At Day 42
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pumarix Formulation 1 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 13 Participants |
| Pumarix Formulation 2 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 140 Participants |
| Pumarix Formulation 3 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 131 Participants |
| Pandemrix Formulation A Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 135 Participants |
| Pandemrix Formulation B Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 131 Participants |
| Pumarix Formulation 4 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 47 Participants |
| Pumarix Formulation 5 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 42 Participants |
Primary
Number of Seroprotected Subjects Against 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.
Time frame: At Day 42
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pumarix Formulation 1 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 13 Participants |
| Pumarix Formulation 2 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 140 Participants |
| Pumarix Formulation 3 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 131 Participants |
| Pandemrix Formulation A Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 135 Participants |
| Pandemrix Formulation B Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 131 Participants |
| Pumarix Formulation 4 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 47 Participants |
| Pumarix Formulation 5 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 42 Participants |
Primary
Number of Subjects With Any Serious Adverse Events (SAEs).
A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 to 182
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 0 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 2 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 1 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 2 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 1 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 1 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Any Serious Adverse Events (SAEs). | 0 Participants |
Primary
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs).
A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.
Time frame: From Day 0 to 182
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 16 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 29 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 1 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 33 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 28 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 34 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 14 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with MAEs | 14 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). | Subjects with NOCDs | 0 Participants |
Primary
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.
Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 15 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 16 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 0 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 25 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 6 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 12 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 4 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 64 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 71 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 23 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 18 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 74 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 49 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 4 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 36 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 3 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 61 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 50 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 12 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 64 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 21 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 86 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 67 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 66 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 53 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 27 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 24 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 12 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 11 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 69 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 63 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 39 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 61 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 21 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 17 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 1 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 15 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 11 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 8 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 5 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 19 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 11 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Muscle Aches | 21 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Shivering | 6 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Headache | 19 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Sweating | 1 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Fatigue | 15 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Fever | 0 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited General Symptoms. | Any Joint Pain | 11 Participants |
Primary
Number of Subjects With Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).
Time frame: Within the 7-day follow-up period (Days 0-6) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 0 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 18 Participants |
| Pumarix Formulation 1 Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 0 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 7 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 133 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 12 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 2 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 130 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 10 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 9 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 139 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 21 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 6 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 124 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 9 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 1 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 48 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 4 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited Local Symptoms. | Any Redness | 0 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited Local Symptoms. | Any Swelling | 0 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Solicited Local Symptoms. | Any Pain | 42 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 21-day follow-up period (Days 0-20) after vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 30 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 67 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 60 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 73 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 84 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 26 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 20 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Between Day 0 and Day 84 after vaccination.
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pumarix Formulation 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 35 Participants |
| Pumarix Formulation 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 77 Participants |
| Pumarix Formulation 3 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 71 Participants |
| Pandemrix Formulation A Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 81 Participants |
| Pandemrix Formulation B Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 89 Participants |
| Pumarix Formulation 4 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 29 Participants |
| Pumarix Formulation 5 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 23 Participants |
Primary
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).
Time frame: At Day 42
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pumarix Formulation 1 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 10.5 Titers |
| Pumarix Formulation 2 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 464.7 Titers |
| Pumarix Formulation 3 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 320.7 Titers |
| Pandemrix Formulation A Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 480.3 Titers |
| Pandemrix Formulation B Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 347.7 Titers |
| Pumarix Formulation 4 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 331.6 Titers |
| Pumarix Formulation 5 Group | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | 173.9 Titers |
Secondary
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.
Time frame: At Days 21 and 182
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 1.2 Fold increase |
| Pumarix Formulation 1 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 1.1 Fold increase |
| Pumarix Formulation 2 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 4.5 Fold increase |
| Pumarix Formulation 2 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 5.6 Fold increase |
| Pumarix Formulation 3 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 4.0 Fold increase |
| Pumarix Formulation 3 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 4.5 Fold increase |
| Pandemrix Formulation A Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 4.7 Fold increase |
| Pandemrix Formulation A Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 5.2 Fold increase |
| Pandemrix Formulation B Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 3.3 Fold increase |
| Pandemrix Formulation B Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 4.5 Fold increase |
| Pumarix Formulation 4 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 4.1 Fold increase |
| Pumarix Formulation 4 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 5.8 Fold increase |
| Pumarix Formulation 5 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 21 | 4.2 Fold increase |
| Pumarix Formulation 5 Group | Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1at Day 182 | 4.0 Fold increase |
Secondary
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 titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on the specified day.
Time frame: At Days 21 and 182
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 5 Participants |
| Pumarix Formulation 1 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 2 Participants |
| Pumarix Formulation 2 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 60 Participants |
| Pumarix Formulation 2 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 77 Participants |
| Pumarix Formulation 3 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 60 Participants |
| Pumarix Formulation 3 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 66 Participants |
| Pandemrix Formulation A Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 64 Participants |
| Pandemrix Formulation A Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 67 Participants |
| Pandemrix Formulation B Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 54 Participants |
| Pandemrix Formulation B Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 62 Participants |
| Pumarix Formulation 4 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 23 Participants |
| Pumarix Formulation 4 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 24 Participants |
| Pumarix Formulation 5 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 21 Participants |
| Pumarix Formulation 5 Group | Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 23 Participants |
Secondary
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.
Time frame: At Days 0, 21 and 182
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 2 Participants |
| Pumarix Formulation 1 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 5 Participants |
| Pumarix Formulation 1 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
| Pumarix Formulation 2 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 60 Participants |
| Pumarix Formulation 2 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
| Pumarix Formulation 2 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 77 Participants |
| Pumarix Formulation 3 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 66 Participants |
| Pumarix Formulation 3 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
| Pumarix Formulation 3 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 60 Participants |
| Pandemrix Formulation A Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 64 Participants |
| Pandemrix Formulation A Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
| Pandemrix Formulation A Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 68 Participants |
| Pandemrix Formulation B Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 54 Participants |
| Pandemrix Formulation B Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
| Pandemrix Formulation B Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 63 Participants |
| Pumarix Formulation 4 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 1 Participants |
| Pumarix Formulation 4 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 26 Participants |
| Pumarix Formulation 4 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 23 Participants |
| Pumarix Formulation 5 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 23 Participants |
| Pumarix Formulation 5 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 21 Participants |
| Pumarix Formulation 5 Group | Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 0 | 0 Participants |
Secondary
Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.
Titers are presented as geometric mean titers (GMTs).
Time frame: At Day 21 and Day 182
Population: 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 Day 42 HI titer results for the A/Indonesia/5/05 virus.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Pumarix Formulation 1 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 6.1 Titers |
| Pumarix Formulation 1 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 5.6 Titers |
| Pumarix Formulation 2 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 22.5 Titers |
| Pumarix Formulation 2 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 27.8 Titers |
| Pumarix Formulation 3 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 19.9 Titers |
| Pumarix Formulation 3 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 22.6 Titers |
| Pandemrix Formulation A Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 23.5 Titers |
| Pandemrix Formulation A Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 26.1 Titers |
| Pandemrix Formulation B Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 16.8 Titers |
| Pandemrix Formulation B Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 22.6 Titers |
| Pumarix Formulation 4 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 23.0 Titers |
| Pumarix Formulation 4 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 32.5 Titers |
| Pumarix Formulation 5 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 21 | 20.8 Titers |
| Pumarix Formulation 5 Group | Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. | H5N1 at Day 182 | 20.0 Titers |