Trial Outcomes & Findings for Immunogenicity of H5N1 Vaccine Following H5N2 (NCT NCT02153671)
NCT ID: NCT02153671
Last Updated: 2019-02-18
Results Overview
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional World Health Organization (WHO)-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
56 days
Results posted on
2019-02-18
Participant Flow
Participant milestones
| Measure |
H5N2 Primed
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
24
|
|
Overall Study
COMPLETED
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity of H5N1 Vaccine Following H5N2
Baseline characteristics by cohort
| Measure |
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.3 years
n=5 Participants
|
30.8 years
n=7 Participants
|
30.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 56 daysThe following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional World Health Organization (WHO)-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
2.7 titer
Interval 2.3 to 3.1
|
2.5 titer
Interval 2.5 to 2.5
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
7.2 titer
Interval 3.8 to 13.7
|
3.1 titer
Interval 2.4 to 4.2
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
32.1 titer
Interval 12.8 to 80.5
|
5.9 titer
Interval 3.1 to 11.5
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
37.2 titer
Interval 15.5 to 89.3
|
9.2 titer
Interval 4.4 to 19.0
|
PRIMARY outcome
Timeframe: 56 daysThe following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
2.5 titer
Interval 2.5 to 2.5
|
2.5 titer
Interval 2.5 to 2.5
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
5.2 titer
Interval 2.4 to 11.1
|
3.1 titer
Interval 2.3 to 4.2
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
43.0 titer
Interval 14.7 to 125.9
|
5.8 titer
Interval 3.1 to 10.8
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
62.0 titer
Interval 23.3 to 164.9
|
7.1 titer
Interval 3.7 to 13.4
|
PRIMARY outcome
Timeframe: 56 daysThe following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
2.6 titer
Interval 2.4 to 2.8
|
2.6 titer
Interval 2.4 to 3.0
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
6.5 titer
Interval 3.7 to 11.3
|
3.4 titer
Interval 2.4 to 4.9
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
35.9 titer
Interval 12.6 to 102.1
|
8.7 titer
Interval 4.4 to 17.2
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
49.8 titer
Interval 21.2 to 117.2
|
11.9 titer
Interval 5.9 to 23.9
|
PRIMARY outcome
Timeframe: 56 daysThe following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
2.5 titer
Interval 2.5 to 2.5
|
2.5 titer
Interval 2.5 to 2.5
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
7.5 titer
Interval 3.0 to 18.5
|
3.1 titer
Interval 2.3 to 4.3
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
32.1 titer
Interval 10.3 to 100.6
|
5.9 titer
Interval 3.1 to 11.2
|
|
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
44.6 titer
Interval 17.5 to 113.5
|
9.2 titer
Interval 4.7 to 17.8
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
14.4 titer
Interval 9.7 to 21.3
|
6.1 titer
Interval 5.3 to 7.0
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
138.3 titer
Interval 55.7 to 343.1
|
25.2 titer
Interval 12.7 to 49.9
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
413.1 titer
Interval 205.7 to 829.7
|
58.2 titer
Interval 26.9 to 126.0
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
370.3 titer
Interval 223.4 to 613.7
|
155.4 titer
Interval 91.0 to 265.5
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50).
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
8.0 titer
Interval 6.3 to 10.3
|
5.5 titer
Interval 4.9 to 6.0
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
66.7 titer
Interval 26.8 to 165.7
|
15.9 titer
Interval 9.5 to 26.6
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
165.9 titer
Interval 83.2 to 331.1
|
31.7 titer
Interval 17.6 to 57.3
|
|
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
239.0 titer
Interval 142.9 to 399.7
|
73.4 titer
Interval 47.1 to 114.2
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
5 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
14 Participants
|
22 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
13 Participants
|
6 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
6 Participants
|
18 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
15 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
4 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
14 Participants
|
12 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
5 Participants
|
12 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
5 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
14 Participants
|
22 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
11 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
8 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
8 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
11 Participants
|
22 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
12 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
7 Participants
|
14 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
15 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
4 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
5 Participants
|
17 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
14 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
5 Participants
|
14 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
7 Participants
|
3 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
12 Participants
|
21 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
14 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
12 Participants
|
11 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
7 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
18 Participants
|
18 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
1 Participants
|
6 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
18 Participants
|
23 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
11 Participants
|
11 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
8 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
18 Participants
|
16 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
1 Participants
|
8 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
19 Participants
|
23 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 56 daysSeroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
8 Participants
|
21 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
14 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
5 Participants
|
17 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
4 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
15 Participants
|
23 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titers for Serum Hemagglutination Inhibition (HAI) Antibody Against 17/t/Tur (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
11 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 56 daysSeroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
14 Participants
|
23 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
11 Participants
|
3 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
8 Participants
|
21 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
14 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
5 Participants
|
17 Participants
|
PRIMARY outcome
Timeframe: 56 daysSeroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
2 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
17 Participants
|
22 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
12 Participants
|
4 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
7 Participants
|
20 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
14 Participants
|
9 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
5 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 56 daysSeroprotection was defined as ≥1:40 antibody titer. The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with the conventional WHO-recommended assays. Sera were pretreated with receptor destroying enzyme (RDE, Denka Seiken, Japan) and tested against 4 HA units of several H5 antigens using horse red blood cells.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
14 Participants
|
23 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
11 Participants
|
4 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
8 Participants
|
20 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
14 Participants
|
8 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Serum Hemagglutination Inhibition (HAI) Antibody Against A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
5 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
15 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
4 Participants
|
17 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
19 Participants
|
14 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
0 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
19 Participants
|
22 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 56 daysSerum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the virus in the tissue culture (TCID50). Seroprotection was defined as ≥1:40 antibody titer.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroprotection
|
12 Participants
|
6 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroprotection
|
7 Participants
|
18 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroprotection
|
17 Participants
|
11 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroprotection
|
2 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroprotection
|
19 Participants
|
21 Participants
|
|
Number and Percentage of Subjects With Seroprotective Titer of Microneutralization (MN) Antibody Against A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroprotection
|
0 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 56 daysDetection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
4.5 titer
Standard Deviation 1.4
|
4.0 titer
Standard Deviation 1.7
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
6.2 titer
Standard Deviation 1.9
|
5.0 titer
Standard Deviation 1.4
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
6.8 titer
Standard Deviation 1.5
|
5.3 titer
Standard Deviation 1.5
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
6.7 titer
Standard Deviation 1.4
|
5.2 titer
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 56 daysDetection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
2.5 titer
Standard Deviation 0.8
|
2.5 titer
Standard Deviation 1.2
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
5.3 titer
Standard Deviation 2.4
|
4.1 titer
Standard Deviation 1.5
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
5.6 titer
Standard Deviation 2.3
|
3.9 titer
Standard Deviation 2.1
|
|
Geometric Mean Titer of Serum Immunoglobulin A (IgA) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
5.6 titer
Standard Deviation 1.9
|
4.2 titer
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 56 daysDetection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
9.7 titer
Standard Deviation 0.9
|
9.0 titer
Standard Deviation 1.1
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
10.4 titer
Standard Deviation 1.1
|
9.7 titer
Standard Deviation 1.2
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
11.2 titer
Standard Deviation 1.1
|
10.2 titer
Standard Deviation 1.3
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
11.3 titer
Standard Deviation 0.9
|
10.6 titer
Standard Deviation 1.0
|
PRIMARY outcome
Timeframe: 56 daysDetection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 0
|
8.3 titer
Standard Deviation 1.1
|
9.5 titer
Standard Deviation 1.1
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7
|
10.4 titer
Standard Deviation 1.1
|
9.7 titer
Standard Deviation 1.2
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28
|
11.2 titer
Standard Deviation 1.1
|
10.2 titer
Standard Deviation 1.3
|
|
Geometric Mean Titer of Serum Immunoglobulin G (IgG) Response to A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56
|
10.3 titer
Standard Deviation 0.9
|
9.2 titer
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
9 Participants
|
8 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
10 Participants
|
16 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
13 Participants
|
9 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
6 Participants
|
15 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
13 Participants
|
9 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
6 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
15 Participants
|
12 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
4 Participants
|
12 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
15 Participants
|
11 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
4 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
15 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
4 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
3 Participants
|
4 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
16 Participants
|
20 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
9 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
10 Participants
|
17 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
10 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
9 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 56 daysA four-fold or greater antibody rise in titer was considered to be a seroconversion. Detection of anti-hemagglutinin (HA) immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies was carried out by indirect enzyme-linked immunosorbent assay (ELISA). 16 HA units of sucrose-purified virus antigen was used to coat ELISA plates in a volume of 100 ml. Two-fold dilutions of sera were prepared starting from 1:10 (for IgA antibody) and 1:100 (for IgG antibody) and added to the coated wells, followed by incubation with the horseradish peroxidase-conjugated goat anti-human IgA or IgG.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · Seroconversion
|
5 Participants
|
6 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 7 · No seroconversion
|
14 Participants
|
18 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · Seroconversion
|
11 Participants
|
11 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 28 · No seroconversion
|
8 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · Seroconversion
|
11 Participants
|
15 Participants
|
|
Number and Percentage of Subjects With Seroconversion for Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Day 56 · No seroconversion
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · Yes
|
6 Participants
|
2 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · No
|
8 Participants
|
7 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · Yes
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · No
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · Yes
|
5 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · No
|
6 Participants
|
10 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · Yes
|
6 Participants
|
1 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · No
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=17 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=16 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · Yes
|
9 Participants
|
3 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · No
|
8 Participants
|
13 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · Yes
|
7 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · No
|
10 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=17 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · Yes
|
2 Participants
|
0 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7 · No
|
9 Participants
|
17 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · Yes
|
6 Participants
|
3 Participants
|
|
Number and Percentage of Subjects With ≥15% Increase of Avidity Index in Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28 · No
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=14 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=9 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 0
|
75.6 avidity index
Standard Deviation 14.6
|
75.2 avidity index
Standard Deviation 8.6
|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7
|
87.7 avidity index
Standard Deviation 9.3
|
81.5 avidity index
Standard Deviation 10.3
|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28
|
87.2 avidity index
Standard Deviation 8.6
|
85.1 avidity index
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 0
|
81.6 avidity index
Standard Deviation 11.8
|
83.4 avidity index
Standard Deviation 9.7
|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7
|
90.7 avidity index
Standard Deviation 5.7
|
86.0 avidity index
Standard Deviation 12.0
|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28
|
92.3 avidity index
Standard Deviation 6.4
|
84.2 avidity index
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=17 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=16 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 0
|
72.7 avidity index
Standard Deviation 7.5
|
77.4 avidity index
Standard Deviation 6.4
|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7
|
86.4 avidity index
Standard Deviation 12.6
|
83.3 avidity index
Standard Deviation 8.1
|
|
Mean Avidity Index for Serum Immunoglobulin A (IgA) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28
|
84.9 avidity index
Standard Deviation 8.8
|
77.9 avidity index
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Subjects with seroconversion were included in the analysis.
The avidity index (AI) was defined as the ratio of the mean optical density at 450 nm (OD450) with urea to that without urea, multiplied by 100. A 15% increase in the AI value was considered significant.
Outcome measures
| Measure |
H5N2 Primed
n=11 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=17 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 7
|
86.2 avidity index
Standard Deviation 10.6
|
78.0 avidity index
Standard Deviation 9.1
|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 0
|
76.2 avidity index
Standard Deviation 4.9
|
78.3 avidity index
Standard Deviation 8.2
|
|
Mean Avidity Index for Serum Immunoglobulin G (IgG) Against A/Turkey/Turkey/5/05 (H5N1) PR8-based Candidate Vaccine Virus After Receiving One Dose of A(H5N1) Inactivated Influenza Vaccine
Day 28
|
90.6 avidity index
Standard Deviation 14.2
|
77.9 avidity index
Standard Deviation 15.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysSubjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination.
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 1 · Mild
|
13 Participants
|
14 Participants
|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 1 · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 1 · None
|
6 Participants
|
9 Participants
|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 2 · Mild
|
9 Participants
|
3 Participants
|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 2 · Moderate
|
1 Participants
|
1 Participants
|
|
Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Post-dose 2 · None
|
9 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 daysSubjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
Outcome measures
| Measure |
H5N2 Primed
n=19 Participants
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 Participants
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine
Post-dose 1 · Experienced treatment-related adverse event
|
11 Participants
|
9 Participants
|
|
Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine
Post-dose 1 · Did not experience treatment-related adverse event
|
8 Participants
|
15 Participants
|
|
Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine
Post-dose 2 · Experienced treatment-related adverse event
|
9 Participants
|
4 Participants
|
|
Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine
Post-dose 2 · Did not experience treatment-related adverse event
|
10 Participants
|
20 Participants
|
Adverse Events
H5N2 Primed
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
H5N2 Primed
n=19 participants at risk
Subjects who received A(H5N1) inactivated influenza vaccine as well as A(H5N2) live attenuated influenza vaccine approximately 1.5 years before
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
A(H5N2) live attenuated influenza vaccine (LAIV): Two doses administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
|
Control
n=24 participants at risk
Subjects who received A(H5N1) inactivated influenza vaccine and did not receive A(H5N2) live attenuated influenza vaccine in a previous study.
A(H5N1) inactivated influenza vaccine (IIV): Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
4.2%
1/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
0.00%
0/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
4.2%
1/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
0.00%
0/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
0.00%
0/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
0.00%
0/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
0.00%
0/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Bilirubin increased
|
0.00%
0/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
16.7%
4/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Blood creatinine increased
|
15.8%
3/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
4.2%
1/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Eosinophil count increased
|
42.1%
8/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
16.7%
4/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Lymphocyte count increased
|
26.3%
5/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
4.2%
1/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Lymphocyte count decreased
|
42.1%
8/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
25.0%
6/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Monocyte count increased
|
21.1%
4/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
20.8%
5/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Neutrophil count increased
|
36.8%
7/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
33.3%
8/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
Neutrophil count decreased
|
36.8%
7/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
33.3%
8/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
|
Investigations
White blood cells count increased
|
5.3%
1/19 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
8.3%
2/24 • 56 days
Subjects were asked to closely watch for and report any adverse events occurring the first 6 days after immunization, and followed for any reactions and adverse events occurring within 7 and 28 days after each vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place