| 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 | Participants who received Dose 1 (Day 0), analyzed up to Day 7. | Posted | | Number | | occurrences | | Days 0 to 7 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 | | OG004 | 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 | | OG005 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00070
- OG00170
- OG00270
- OG003
|
| | Title | Denominators | Categories |
|---|
| Total number solicited local AEs (Adverse Events) | | | Title | Measurements |
|---|
| - OG00034
- OG00141
- OG00234
- OG003
|
|
| |
| 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 | Participants who received Dose 2 (Day 21), analyzed up to Day 28. | Posted | | Number | | occurrences | | Days 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 |
|
| 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 | Participants who received Dose 1 (Day 0), analyzed up to Day 7. | Posted | | Count of Participants | | Participants | | Days 0 to 7 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | Participants who received Dose 2 (Day 21), analyzed up to Day 28. | Posted | | Count of Participants | | Participants | | Days 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | Participants who received Dose 1 (Day 0), analyzed up to Day 7. | Posted | | Number | 95% Confidence Interval | participants | | Days 0 to 7 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | Participants who received Dose 2 (Day 21), analyzed up to Day 28. | Posted | | Number | 95% Confidence Interval | participants | | Days 21 to 28 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days). | Posted | | Geometric Mean | 95% Confidence Interval | antibody titers | | 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | Participants who received Dose 2 (Day 28) of vaccine, analyzed at Day 42 (plus or minus 3 days). | Posted | | Median | Full Range | antibody titers | | 21 days after receipt of second dose of vaccine (Day 42) (plus or minus 3 days) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | | Posted | | Count of Participants | | Participants | | First vaccination through 13 months | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 |
|
| 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. | | Posted | | Count of Participants | | Participants | | First vaccination through approximately 13 months after first vaccination | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 |
|
| Secondary | Number of Participants With Unsolicited Adverse Events (AE) | Number of participants with unsolicited adverse events (AE) through Visit 8 (Day 201) | | Posted | | Count of Participants | | Participants | | Day 0 (Visit 1) through Day 201 (Visit 8) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) | |
|
| 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) | | Posted | | Number | | Unsolicited Adverse Events (AE) | | 21 days following each vaccination (Days 0-21, >21 Days) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) |
|
| Secondary | Occurrence of Clinical Safety Laboratory AEs | Occurrence of clinical safety laboratory AEs at 7 and 21 days after each vaccination | | Posted | | Number | | Clinical safety lab results reported | | 7 and 21 days after each vaccination (Days 0, 7, 21, 28, and 42) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 15 mcg H5N1 (Monobulk) Plus MF59 (Vials) |
|
| 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 | Population receiving Dose 1 at Day 0 (Visit 1) | Posted | | Geometric Mean | 95% Confidence Interval | antibody titers | | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 201 (Visit 8) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | |
|
| 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 | Population receiving Dose 1 at Day 0 (Visit 1) | Posted | | Geometric Mean | 95% Confidence Interval | antibody titers | | Day 0 (Visit 1), Day 21 (Visit 4), Day 28 (Visit 6), Day 42 (Visit 7), Day 201 (Visit 8) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | |
|
| 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 | Participants who satisfied the predefined criteria for assessment. | Posted | | Count of Participants | | Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | 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/G5N1 vaccine and MF59 stored long term as bulk MF59 adjuvant | | OG001 | 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 | | OG002 | 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 |
|
| 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. | Participants who satisfied the predefined criteria | Posted | | Count of Participants | | Participants | | Days 21, 28, 42, and 201 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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. | Participants who satisfied the predefined criteria | Posted | | Count of Participants | | Participants | | Days 21, 28, 42, and 201 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|