Influenza
Conditions
Keywords
Pandemic influenza
Brief summary
This observer-blind study is designed to show the immunological non-inferiority of Thiomersal-free-processed pandemic influenza vaccine as compared to the Thiomersal-containing-processed pandemic influenza vaccine.
Interventions
BIOLOGICALGSK1562902A
new-processed (NP), administered intramuscularly in the deltoid region of the non-dominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female aged 18 to 60 years 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, 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 * 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. * If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
* 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. * An oral temperature ≥ 37.8 º 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 (prednisone ≥ 5 mg/kg/day for more than 14 consecutive days) 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 Coumarin derivatives or Heparin. * Administration of any vaccines within 30 days before study enrolment. * Previous administration of any H5N1 vaccine. * Previous administration of vaccines with adjuvants similar to those used in the investigational 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 enrolment, or during the 180 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 3 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 (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 women. * 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. * Known use of an analgesic or antipyretic medication within 12 hours prior to first treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies | At Day 42 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | At Days 0, 42 and 180 | The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Seroconverted Subjects Against Two Strains of Influenza Disease | At Day 42 and Day 180 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (\<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Seroconversion Factor (SCF) for H5N1 HI Antibodies | At Day 42 and Day 180 | The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Seroprotected Subjects for H5N1 HI Antibodies | At Days 0, 42 and 180 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | At Days 0, 42 and 180 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004. |
| Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | At Days 0, 42 and 180 | Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004. |
| Number of Seroconverted Subjects for Neutralizing Antibodies | At Day 42 and Day 180 | A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004. |
| Titers for Serum H5N1 HI Antibodies | At Day 0 and Day 180 | Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Adverse Events of Specific Interest (AESIs) | From Day 0 up to 51 days after the first vaccination | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Any AESIs | During the entire study period (from Day 0 up to Day 180) | An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to Day 51 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With SAEs | During the entire study period (from Day 0 up to Day 180) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1562902A NP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. | 160 |
| 1562902A CP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21. | 160 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 0 | 1 |
Baseline characteristics
| Characteristic | 1562902A NP Group | 1562902A CP Group | Total |
|---|---|---|---|
| Age, Continuous | 31.30 Years STANDARD_DEVIATION 7.95 | 32.60 Years STANDARD_DEVIATION 9.1 | 31.95 Years STANDARD_DEVIATION 8.56 |
| Race/Ethnicity, Customized Asian - East-Asian heritage | 160 Participants | 160 Participants | 320 Participants |
| Sex: Female, Male Female | 80 Participants | 83 Participants | 163 Participants |
| Sex: Female, Male Male | 80 Participants | 77 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 160 | 0 / 160 |
| other Total, other adverse events | 155 / 160 | 150 / 160 |
| serious Total, serious adverse events | 4 / 160 | 2 / 160 |
Outcome results
Primary
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.
Time frame: At Day 42
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 1562902A NP Group | Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies | 739.5 Titers |
| 1562902A CP Group | Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies | 621.7 Titers |
Comparison: Difference in adjusted GMT ratio for HI antibodies: To demonstrate that the NP 1562902A vaccine was non-inferior to the CP 1562902A vaccine, with respect to HI antibody GMT against the A/Indonesia/05/2005 strain, 42 days following vaccination.95% CI: [0.71, 0.99]ANCOVA
Secondary
Number of Seroconverted Subjects Against Two Strains of Influenza Disease
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (\<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Day 42 and Day 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Indonesia/05/2005, Day 42 | 156 Participants |
| 1562902A NP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Indonesia/05/2005, Day 180 | 129 Participants |
| 1562902A NP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 143 Participants |
| 1562902A NP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Vietnam/1194/2004, Day 180 | 34 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Vietnam/1194/2004, Day 180 | 13 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Indonesia/05/2005, Day 42 | 153 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 126 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects Against Two Strains of Influenza Disease | A/Indonesia/05/2005, Day 180 | 104 Participants |
Secondary
Number of Seroconverted Subjects for Neutralizing Antibodies
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \< 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.
Time frame: At Day 42 and Day 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Seroconverted Subjects for Neutralizing Antibodies | A/Vietnam/1194/2004, Day 42 | 15 Participants |
| 1562902A NP Group | Number of Seroconverted Subjects for Neutralizing Antibodies | A/Vietnam/1194/2004, Day 180 | 7 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects for Neutralizing Antibodies | A/Vietnam/1194/2004, Day 42 | 13 Participants |
| 1562902A CP Group | Number of Seroconverted Subjects for Neutralizing Antibodies | A/Vietnam/1194/2004, Day 180 | 9 Participants |
Secondary
Number of Seroprotected Subjects for H5N1 HI Antibodies
A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Days 0, 42 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 0 | 0 Participants |
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 42 | 156 Participants |
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 129 Participants |
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 0 | 1 Participants |
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 42 | 144 Participants |
| 1562902A NP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 34 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 42 | 127 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 0 | 0 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 0 | 3 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 42 | 153 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 16 Participants |
| 1562902A CP Group | Number of Seroprotected Subjects for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 104 Participants |
Secondary
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to 51 days after the first vaccination
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1562902A NP Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs) | 1 Participants |
| 1562902A CP Group | Number of Subjects With Any Adverse Events of Specific Interest (AESIs) | 0 Participants |
Secondary
Number of Subjects With Any AESIs
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1562902A NP Group | Number of Subjects With Any AESIs | 1 Participants |
| 1562902A CP Group | Number of Subjects With Any AESIs | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 141 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 9 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 3 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 13 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 137 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 9 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 4 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 17 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 152 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 12 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 4 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 21 Participants |
| 1562902A NP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 8 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 137 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 12 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 5 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 14 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 19 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 133 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 146 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 3 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 66 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 9 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 90 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 60 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 11 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 11 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 10 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 62 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 27 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 10 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 88 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 32 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 31 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 31 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 104 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 26 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 9 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 102 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 87 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 59 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 10 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 4 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 8 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 59 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 110 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 87 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 8 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 1 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 109 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 51 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 4 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 51 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 9 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 16 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 67 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 10 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 27 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 7 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 10 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 10 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 16 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 14 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 13 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 68 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 65 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 43 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 40 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 78 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 75 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 1 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 1 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 1 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 1 | 10 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 1 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 1 | 8 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 27 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 27 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 82 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 82 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 49 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 49 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 62 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 3 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 62 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 2 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Dose 2 | 11 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Dose 2 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Dose 2 | 11 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Dose 2 | 11 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Dose 2 | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Dose 2 | 10 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 12 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 12 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 33 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 32 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 99 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 6 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 98 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 68 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 4 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 67 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 101 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 5 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 101 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Shivering, Across doses | 14 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Shivering, Across doses | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Shivering, Across doses | 14 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Sweating, Across doses | 18 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Sweating, Across doses | 0 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Sweating, Across doses | 15 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 16 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 2 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 49 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 4 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 53 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 8 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 54 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
| 1562902A NP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 15 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 62 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 8 Participants |
| 1562902A CP Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 12 Participants |
Secondary
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value
The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Days 0, 42 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 0 | 0 Participants |
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 42 | 156 Participants |
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 180 | 145 Participants |
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 0 | 2 Participants |
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 42 | 149 Participants |
| 1562902A NP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 180 | 82 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 42 | 140 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 0 | 3 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 0 | 3 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 42 | 154 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 180 | 50 Participants |
| 1562902A CP Group | Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value | A/Indonesia/05/2005, Day 180 | 128 Participants |
Secondary
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.
Time frame: At Days 0, 42 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1562902A NP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 0 | 56 Participants |
| 1562902A NP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 42 | 57 Participants |
| 1562902A NP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 180 | 57 Participants |
| 1562902A CP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 0 | 59 Participants |
| 1562902A CP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 42 | 59 Participants |
| 1562902A CP Group | Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value | A/Vietnam/1194/2004, Day 180 | 59 Participants |
Secondary
Number of Subjects With SAEs
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1562902A NP Group | Number of Subjects With SAEs | 4 Participants |
| 1562902A CP Group | Number of Subjects With SAEs | 2 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 up to Day 51
Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1562902A NP Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| 1562902A CP Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Seroconversion Factor (SCF) for H5N1 HI Antibodies
The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Day 42 and Day 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 1562902A NP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 42 | 147.9 Fold change |
| 1562902A NP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 10.4 Fold change |
| 1562902A NP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 42 | 15.6 Fold change |
| 1562902A NP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 2.5 Fold change |
| 1562902A CP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 1.6 Fold change |
| 1562902A CP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 42 | 121.9 Fold change |
| 1562902A CP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 42 | 10.8 Fold change |
| 1562902A CP Group | Seroconversion Factor (SCF) for H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 6.5 Fold change |
Secondary
Titers for Serum H5N1 HI Antibodies
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.
Time frame: At Day 0 and Day 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 1562902A NP Group | Titers for Serum H5N1 HI Antibodies | A/Indonesia/05/2005, Day 0 | 5.0 Titers |
| 1562902A NP Group | Titers for Serum H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 51.9 Titers |
| 1562902A NP Group | Titers for Serum H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 0 | 5.1 Titers |
| 1562902A NP Group | Titers for Serum H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 12.6 Titers |
| 1562902A CP Group | Titers for Serum H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 180 | 8.4 Titers |
| 1562902A CP Group | Titers for Serum H5N1 HI Antibodies | A/Indonesia/05/2005, Day 0 | 5.1 Titers |
| 1562902A CP Group | Titers for Serum H5N1 HI Antibodies | A/Vietnam/1194/2004, Day 0 | 5.2 Titers |
| 1562902A CP Group | Titers for Serum H5N1 HI Antibodies | A/Indonesia/05/2005, Day 180 | 33.0 Titers |
Secondary
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease
Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.
Time frame: At Days 0, 42 and 180
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 1562902A NP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 189.1 Titers |
| 1562902A NP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 376.7 Titers |
| 1562902A NP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 180 | 184.5 Titers |
| 1562902A CP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 0 | 166.3 Titers |
| 1562902A CP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 42 | 359.2 Titers |
| 1562902A CP Group | Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease | A/Vietnam/1194/2004, Day 180 | 197.3 Titers |