A/Vietnam/H5N1 Influenza Virus
Conditions
Brief summary
The main purpose of this study is to assess the usability of long-term stored H5N1 antigen and adjuvant. The study is designed to assist in stockpile management by assessing the safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine when administered with or without MF59® adjuvant.
Detailed description
This study is a randomized, double-blinded, Phase 2 study to assess the safety and immunogenicity of 2 doses of long-term stored inactivated monovalent influenza A/Vietnam/H5N1 virus vaccine administered intramuscularly with or without MF59 adjuvant in healthy males and nonpregnant females, aged 18 to 49 years, inclusive. This study is designed to assist in stockpile management and will assess the usability of long-term stored H5N1 antigen (ie, stored \>10 years) and adjuvant (ie, stored \>5 years).
Interventions
BIOLOGICAL7.5 mcg H5N1 (stored as monobulk)
BIOLOGICAL15 mcg H5N1 (stored as monobulk)
BIOLOGICAL90 mcg H5N1 (stored as monobulk)
BIOLOGICAL90 mcg H5N1 (stored in vials)
OTHERMF59
OTHERMF59 (stored as monobulk)
Sponsors
PPD Development, LP
Biomedical Advanced Research and Development Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or nonpregnant female * Provide written informed consent prior to study-related procedures * Stable health status * Access to consistent and reliable means of telephone contact * Able to understand and comply with planned study procedures * Agree to stay in contact with site, and no plans to move from study area for study duration
Exclusion criteria
* Allergic to eggs, other vaccine components, or squalene-based adjuvants * Women with positive pregnancy test within 24 hours of vaccination, or are breastfeeding * Females of childbearing potential who refuse acceptable birth control, if sexually active, have not used birth control for 2 months prior to study entry * Have immunosuppression or use anticancer chemotherapy or radiation therapy within preceding 36 months * Have an active neoplastic disease or history of hematologic malignancy * Have long term use (≥14 consecutive days) of glucocorticoids (\>20 mg/day) or high-dose inhaled steroids (\>800 mcg/day) within preceding 6 months * Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis * Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to self or others within past 10 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Days 0 to 7 | Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1 |
| Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Days 0 to 7 | Number of participants with \>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1 |
| Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Days 0 to 7 | Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1 |
| Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Days 21 to 28 | Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2 |
| Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days) | Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Unsolicited Adverse Events (AE) | 21 days following each vaccination (Days 0-21, >21 Days) | Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (\>21 Days) |
| Occurrence of Clinical Safety Laboratory AEs | 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42) | Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination |
| GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8) | Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201 |
| Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Days 21, 28, 42, and 201 | Defined as proportion of subjects achieving either a prevaccination HAI titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection. |
| Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Days 21, 28, 42, and 201 | Defined as proportion of subjects achieving either a prevaccination MN titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection. |
| Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days) | Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen |
| GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8) | GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201 |
| Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | First vaccination through 13 months | Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal |
| Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | First vaccination through approximately 13 months after first vaccination | Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal. |
| Number of Participants With Unsolicited Adverse Events (AE) | Day 0 (Visit 1) through Day 201 (Visit 8) | Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201) |
Countries
United States
Participant flow
Recruitment details
Participants were screened and enrolled at 6 sites in the US.
Participants by arm
| Arm | Count |
|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg hemagglutinin (HA) antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant | 70 |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored long term as monobulk MF59 adjuvant | 70 |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) Two 0.5-mL doses, given at Day 0 and 21 consisting of 7.5 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant | 70 |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) Two 0.5-mL doses, given at Day 0 and 21 consisting of 15 mcg HA antigen stored long term as monobulk inactivated A/Vietnam/H5N1 vaccine and MF59 stored short term in vials as MF59 adjuvant | 71 |
| 90 mcg H5N1 (Monobulk) Without MF59 Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term as monobulk inactivated A/Vietnam/H5N1 antigen formulated and filled in 2015, administered without MF59 | 70 |
| 90 mcg H5N1 (Vials) Without MF59 Two 1.0-mL doses at Day 0 and 21 consisting of 90 mcg HA antigen stored long-term in vials as inactivated A/Vietnam/H5N1 vaccine, administered without MF59 | 68 |
| Total | 419 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 5 | 1 | 4 | 2 | 0 | 2 |
| Overall Study | Missed Visit 8 (Day 201) | 2 | 1 | 3 | 1 | 5 | 0 |
| Overall Study | Other | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 5 | 1 | 1 | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | 90 mcg H5N1 (Monobulk) Without MF59 | 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Total | 90 mcg H5N1 (Vials) Without MF59 |
|---|---|---|---|---|---|---|---|
| Age, Customized 18 to <30 | 21 participants | 11 participants | 18 participants | 17 participants | 16 participants | 98 participants | 15 participants |
| Age, Customized 30 to <40 | 22 participants | 26 participants | 21 participants | 28 participants | 22 participants | 150 participants | 31 participants |
| Age, Customized 40 to 49 | 27 participants | 33 participants | 31 participants | 26 participants | 32 participants | 171 participants | 22 participants |
| Age, Customized | 37.0 years | 38.5 years | 37.5 years | 37.0 years | 38.0 years | 37 years | 35.0 years |
| Body Mass Index (BMI) | 31.76 kg/m2 STANDARD_DEVIATION 8.13 | 31.75 kg/m2 STANDARD_DEVIATION 8.35 | 30.76 kg/m2 STANDARD_DEVIATION 8.59 | 30.50 kg/m2 STANDARD_DEVIATION 8.15 | 32.79 kg/m2 STANDARD_DEVIATION 9.29 | 31.52 kg/m2 STANDARD_DEVIATION 8.62 | 31.57 kg/m2 STANDARD_DEVIATION 9.27 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants | 18 Participants | 14 Participants | 22 Participants | 27 Participants | 116 Participants | 18 Participants |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 51 Participants | 50 Participants | 52 Participants | 47 Participants | 43 Participants | 289 Participants | 46 Participants |
| Region of Enrollment United States | 70 participants | 70 participants | 70 participants | 71 participants | 70 participants | 419 participants | 68 participants |
| Sex: Female, Male Female | 41 Participants | 33 Participants | 50 Participants | 43 Participants | 43 Participants | 249 Participants | 39 Participants |
| Sex: Female, Male Male | 29 Participants | 37 Participants | 20 Participants | 28 Participants | 27 Participants | 170 Participants | 29 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 71 | 0 / 70 | 0 / 71 | 0 / 70 | 0 / 69 |
| other Total, other adverse events | 44 / 70 | 49 / 71 | 47 / 70 | 57 / 71 | 48 / 70 | 47 / 69 |
| serious Total, serious adverse events | 0 / 70 | 1 / 71 | 3 / 70 | 0 / 71 | 1 / 70 | 2 / 69 |
Outcome results
Primary
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Time frame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
Population: Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 40.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 40.0 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 40.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 56.6 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 20 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 14.1 antibody titers |
Primary
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody
Geometric Mean Titer (GMT) of hemagglutination inhibition (HAI) antibody against A/Vietnam/H5N1 antigen in each study group
Time frame: 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days)
Population: Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 38 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 29.6 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 37.4 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 49.4 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 19.4 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibody | 19.9 antibody titers |
Primary
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Time frame: Days 0 to 7
Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 34 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 31 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 3 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 4 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 37 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 41 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 4 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 30 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 34 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 34 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 2 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 29 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 3 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 5 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 23 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 28 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 29 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 4 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 33 occurrences |
Primary
Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Occurence of mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 28) following Dose 2
Time frame: Days 21 to 28
Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 26 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 0 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 26 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 2 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 22 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 24 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 23 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 23 occurrences |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 0 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 1 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 23 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 24 occurrences |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 18 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 17 occurrences |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 1 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited AEs | 2 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited AEs | 0 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 23 occurrences |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Occurences of Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited AEs | 21 occurrences |
Primary
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Number of participants with \>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 0 to 7) following Dose 1
Time frame: Days 0 to 7
Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 2 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 23 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 25 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 31 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 28 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 3 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 27 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 24 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 3 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 27 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 2 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 24 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 18 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 22 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 4 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 21 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 4 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 25 Participants |
Primary
Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination.
Number of participants with \>=1 mild, moderate, or severe solicited local symptoms during the 7 days (Days 21 to 29) following Dose 2
Time frame: Days 21 to 28
Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 20 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 20 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 19 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 20 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 17 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 17 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 21 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 20 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 1 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 1 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 16 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 17 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited local AEs | 19 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited local AEs | 2 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited local AEs | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With >=1 (More Than or Equal to 1) Mild, Moderate, or Severe Solicited Local Symptoms During the 7 Days After Each Vaccination. | Total number solicited local AEs (Adverse Events) | 21 Participants |
Primary
Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Number of participants with mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 0 to 7) following Dose 1
Time frame: Days 0 to 7
Population: Participants who received Dose 1 (Day 0), analyzed up to Day 7.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 20 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 13 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 7 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 3 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 17 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 14 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 17 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 23 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 6 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 1 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 4 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 24 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 19 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 13 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 17 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 4 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 3 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 13 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 18 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 2 participants |
Primary
Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination.
Number of participants with of mild, moderate, or severe solicited systemic reactogenicity adverse events during the 7 days (Days 21 to 28) following Dose 2
Time frame: Days 21 to 28
Population: Participants who received Dose 2 (Day 21), analyzed up to Day 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 11 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 8 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 3 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 10 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 0 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 10 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 10 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 11 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 1 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 11 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 17 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 6 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 9 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 4 participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 5 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Mild solicited systemic AEs | 9 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. solicited systemic AEs (Adverse Events) | 9 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Moderate solicited systemic AEs | 0 participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With of Mild, Moderate, or Severe Solicited Systemic Reactogenicity Symptoms During the 7 Days After Each Vaccination. | Total no. Severe solicited systemic AEs | 0 participants |
Secondary
Frequency of Unsolicited Adverse Events (AE)
Frequency of unsolicited adverse events (AE) for 21 days following Dose 1 (Days 0-21) and after Dose 2 (\>21 Days)
Time frame: 21 days following each vaccination (Days 0-21, >21 Days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 184 Unsolicited Adverse Events (AE) |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 0 Unsolicited Adverse Events (AE) |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 179 Unsolicited Adverse Events (AE) |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 1 Unsolicited Adverse Events (AE) |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 186 Unsolicited Adverse Events (AE) |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 4 Unsolicited Adverse Events (AE) |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 202 Unsolicited Adverse Events (AE) |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 2 Unsolicited Adverse Events (AE) |
| 90 mcg H5N1 (Monobulk) Without MF59 | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 156 Unsolicited Adverse Events (AE) |
| 90 mcg H5N1 (Monobulk) Without MF59 | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 1 Unsolicited Adverse Events (AE) |
| 90 mcg H5N1 (Vials) Without MF59 | Frequency of Unsolicited Adverse Events (AE) | Days 0-21 | 174 Unsolicited Adverse Events (AE) |
| 90 mcg H5N1 (Vials) Without MF59 | Frequency of Unsolicited Adverse Events (AE) | >21 Days | 4 Unsolicited Adverse Events (AE) |
Secondary
GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies
Overall GMTs of HAI antibodies at baseline (Day 0) and Days 21, 28 and 201
Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8)
Population: Population receiving Dose 1 at Day 0 (Visit 1)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.0 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 11.8 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 18.4 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 6.2 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 18.7 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 8.6 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 5.4 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 5.5 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 17.5 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 8.7 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.4 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.2 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 5.4 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 14.8 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 27.9 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 14.0 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 5.9 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 10.8 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.1 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 4: Day 21 (+1 day) | 14.1 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 6: Day 28 (+1 day) | 20.7 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 6.9 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum HAI (Hemagglutination Inhibition) Antibodies | Visit 1: Day 0 | 5.3 antibody titers |
Secondary
GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies
GMT of serum MN antibodies at baseline (Day 0) and Days 21, 28, 42 and 201
Time frame: Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8)
Population: Population receiving Dose 1 at Day 0 (Visit 1)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 52.2 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 12.2 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 6.1 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 11.3 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 24.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 8.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 43.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 5.5 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 8.8 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 23.8 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 10.9 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 58.8 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 10.9 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 24.9 antibody titers |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 5.5 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 31.1 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 6.0 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 14.2 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 66.4 antibody titers |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 9.9 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 25.0 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 5.4 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 8.9 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 10.7 antibody titers |
| 90 mcg H5N1 (Monobulk) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 16.8 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 1: Day 0 | 5.7 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 30.1 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 15.4 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 11.0 antibody titers |
| 90 mcg H5N1 (Vials) Without MF59 | GMT (Geometric Mean Titers) of Serum Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1 day) | 24.0 antibody titers |
Secondary
Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal.
Number of participants with adverse events of special interest (AESI) or adverse events (AE) leading to study withdrawal.
Time frame: First vaccination through approximately 13 months after first vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 0 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 1 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Event of Special Interest (AESI) | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Adverse Events of Special Interest (AESI) or Adverse Events (AE) Leading to Study Withdrawal. | Adverse Events (AE) leading to study withdrawal | 2 Participants |
Secondary
Number of Participants With Unsolicited Adverse Events (AE)
Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201)
Time frame: Day 0 (Visit 1) through Day 201 (Visit 8)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 28 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 37 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 2 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 36 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 3 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 42 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 2 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 31 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 3 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Unsolicited Adverse Events (AE) | Any unsolicited Adverse Event (AE) | 27 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Unsolicited Adverse Events (AE) | Any severe unsolicited Adverse Event (AE) | 3 Participants |
Secondary
Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI)
Number of participants with vaccine-associated serious adverse events (SAE) or adverse event of special interests (AESI) and occurence of AESIs or AEs leading to study withdrawal
Time frame: First vaccination through 13 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Vaccine-associated Serious Adverse Event (SAE) | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Number of Participants With Vaccine-associated Serious Adverse Events (SAE) or Adverse Event of Special Interests (AESI) | Adverse Event of Special Interest (AESI) | 0 Participants |
Secondary
Occurrence of Clinical Safety Laboratory AEs
Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination
Time frame: 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 1 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 1 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 1 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 1 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 1 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 0 Clinical safety lab results reported |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 0 Clinical safety lab results reported |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Monobulk) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Monobulk) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Monobulk) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Monobulk) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Monobulk) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Vials) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 1: Day 0 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Vials) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 6: Day 28 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Vials) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 3: Day 7 | 1 Clinical safety lab results reported |
| 90 mcg H5N1 (Vials) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 7: Day 42 | 0 Clinical safety lab results reported |
| 90 mcg H5N1 (Vials) Without MF59 | Occurrence of Clinical Safety Laboratory AEs | Visit 4: Day 21 | 0 Clinical safety lab results reported |
Secondary
Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies
Defined as proportion of subjects achieving either a prevaccination HAI titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination HAI titer of at least 1:10 and a 4-fold or greater increase of HAI postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline HAI titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Time frame: Days 21, 28, 42, and 201
Population: Participants who satisfied the predefined criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 22 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 13 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 39 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 25 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 38 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 6 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 41 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 1 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 17 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 8 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 49 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 18 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 33 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 19 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 12 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 21 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 1 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 6: Day 28 (+1day) | 21 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 4: Day 21 (+1 day) | 16 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 3 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Hemagglutination Inhibition (HAI) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 21 Participants |
Secondary
Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies
Defined as proportion of subjects achieving either a prevaccination MN titer of \<1:10 and postvaccination titer of at least 1:40 or a prevaccination MN titer of at least 1:10 and a 4-fold or greater increase of MN postvaccination antibody titers against the A/Vietnam/H5N1 antigen; if baseline MN titer is undetectable, it will be assigned a vaue of half the lower limit of detection.
Time frame: Days 21, 28, 42, and 201
Population: Participants who satisfied the predefined criteria
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 10 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 5 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 42 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 18 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 43 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 21 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 3 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 8 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 44 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 23 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 11 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 52 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 31 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 3 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 13 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 23 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 4 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 15 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 9 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 7: Day 42 (plus or minus 3 days) | 23 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 4: Day 21 (+1 day) | 12 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 6: Day 28 (+1day) | 20 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Seroconversion Rate (SCR) for Microneutralization (MN) Antibodies | Visit 8: Day 201 (plus or minus 7 days) | 7 Participants |
Secondary
Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40
Proportion of participants achieving a serum HAI titer of at least 1:40 against the A/Vietnam/H5N1 antigen
Time frame: Days 0 (Visit 1), 21 (Visit 4, +1day), 28 (Visit 6, +1 day), 42 (Visit 7, plus or minus 3 days), and 201 (Visit 8, plus or minus 7 days)
Population: Participants who satisfied the predefined criteria for assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 22 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 13 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 1 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 0 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 39 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 38 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 6 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 0 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Monobulk) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 25 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 1 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 18 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 1 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 42 Participants |
| 7.5 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 9 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 18 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 1 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 33 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 49 Participants |
| 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 1 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 1 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 12 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 21 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 19 Participants |
| 90 mcg H5N1 (Monobulk) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 0 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 0 (Visit 1) | 1 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 42 (Visit 7, plus or minus 3 days) | 22 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 28 (Visit 6, +1 day) | 22 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 21 (Visit 4, +1 day) | 16 Participants |
| 90 mcg H5N1 (Vials) Without MF59 | Serum HAI (Hemagglutination Inhibition) Titer of at Least 1:40 | Day 201 (Visit 8, plus or minus 7 days) | 3 Participants |