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Immunogenicity of H5N1 Vaccine Following H5N2

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ClinicalTrials.gov Identifier: NCT02153671
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Institute of Experimental Medicine, Russia
Research Institute of Influenza, Russia
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza Vaccine
Interventions Biological: A(H5N1) inactivated influenza vaccine (IIV)
Biological: A(H5N2) live attenuated influenza vaccine (LAIV)
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 19 24
Completed 19 24
Not Completed 0 0
Arm/Group Title Control H5N2 Primed Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 24 19 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 24 participants 19 participants 43 participants
30.3
(20 to 48)
30.8
(20 to 51)
30.5
(20 to 51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 19 participants 43 participants
Female
12
  50.0%
7
  36.8%
19
  44.2%
Male
12
  50.0%
12
  63.2%
24
  55.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 19 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
24
 100.0%
19
 100.0%
43
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
2.7
(2.3 to 3.1)
2.5
(2.5 to 2.5)
Day 7
7.2
(3.8 to 13.7)
3.1
(2.4 to 4.2)
Day 28
32.1
(12.8 to 80.5)
5.9
(3.1 to 11.5)
Day 56
37.2
(15.5 to 89.3)
9.2
(4.4 to 19.0)
2.Primary Outcome
Title 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)
Hide Description 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. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
2.5
(2.5 to 2.5)
2.5
(2.5 to 2.5)
Day 7
5.2
(2.4 to 11.1)
3.1
(2.3 to 4.2)
Day 28
43.0
(14.7 to 125.9)
5.8
(3.1 to 10.8)
Day 56
62.0
(23.3 to 164.9)
7.1
(3.7 to 13.4)
3.Primary Outcome
Title 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)
Hide Description 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. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
2.6
(2.4 to 2.8)
2.6
(2.4 to 3.0)
Day 7
6.5
(3.7 to 11.3)
3.4
(2.4 to 4.9)
Day 28
35.9
(12.6 to 102.1)
8.7
(4.4 to 17.2)
Day 56
49.8
(21.2 to 117.2)
11.9
(5.9 to 23.9)
4.Primary Outcome
Title 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)
Hide Description 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. A four-fold or greater antibody rise in titer was considered to be a seroconversion.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
2.5
(2.5 to 2.5)
2.5
(2.5 to 2.5)
Day 7
7.5
(3.0 to 18.5)
3.1
(2.3 to 4.3)
Day 28
32.1
(10.3 to 100.6)
5.9
(3.1 to 11.2)
Day 56
44.6
(17.5 to 113.5)
9.2
(4.7 to 17.8)
5.Primary Outcome
Title 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)
Hide Description Serum 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).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
14.4
(9.7 to 21.3)
6.1
(5.3 to 7.0)
Day 7
138.3
(55.7 to 343.1)
25.2
(12.7 to 49.9)
Day 28
413.1
(205.7 to 829.7)
58.2
(26.9 to 126.0)
Day 56
370.3
(223.4 to 613.7)
155.4
(91.0 to 265.5)
6.Primary Outcome
Title 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)
Hide Description Serum 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).
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
8.0
(6.3 to 10.3)
5.5
(4.9 to 6.0)
Day 7
66.7
(26.8 to 165.7)
15.9
(9.5 to 26.6)
Day 28
165.9
(83.2 to 331.1)
31.7
(17.6 to 57.3)
Day 56
239.0
(142.9 to 399.7)
73.4
(47.1 to 114.2)
7.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
5
  26.3%
2
   8.3%
No seroconversion
14
  73.7%
22
  91.7%
Day 28 Seroconversion
13
  68.4%
6
  25.0%
No seroconversion
6
  31.6%
18
  75.0%
Day 56 Seroconversion
15
  78.9%
10
  41.7%
No seroconversion
4
  21.1%
14
  58.3%
8.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
5
  26.3%
2
   8.3%
No seroconversion
14
  73.7%
22
  91.7%
Day 28 Seroconversion
11
  57.9%
7
  29.2%
No seroconversion
8
  42.1%
17
  70.8%
Day 56 Seroconversion
14
  73.7%
12
  50.0%
No seroconversion
5
  26.3%
12
  50.0%
9.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
8
  42.1%
2
   8.3%
No seroconversion
11
  57.9%
22
  91.7%
Day 28 Seroconversion
12
  63.2%
10
  41.7%
No seroconversion
7
  36.8%
14
  58.3%
Day 56 Seroconversion
15
  78.9%
13
  54.2%
No seroconversion
4
  21.1%
11
  45.8%
10.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
7
  36.8%
3
  12.5%
No seroconversion
12
  63.2%
21
  87.5%
Day 28 Seroconversion
14
  73.7%
7
  29.2%
No seroconversion
5
  26.3%
17
  70.8%
Day 56 Seroconversion
14
  73.7%
10
  41.7%
No seroconversion
5
  26.3%
14
  58.3%
11.Primary Outcome
Title 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)
Hide Description Serum 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
12
  63.2%
11
  45.8%
No seroconversion
7
  36.8%
13
  54.2%
Day 28 Seroconversion
18
  94.7%
18
  75.0%
No seroconversion
1
   5.3%
6
  25.0%
Day 56 Seroconversion
18
  94.7%
23
  95.8%
No seroconversion
1
   5.3%
1
   4.2%
12.Primary Outcome
Title 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)
Hide Description Serum 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
11
  57.9%
11
  45.8%
No seroconversion
8
  42.1%
13
  54.2%
Day 28 Seroconversion
18
  94.7%
16
  66.7%
No seroconversion
1
   5.3%
8
  33.3%
Day 56 Seroconversion
19
 100.0%
23
  95.8%
No seroconversion
0
   0.0%
1
   4.2%
13.Primary Outcome
Title 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)
Hide Description Seroprotection 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
4
  21.1%
1
   4.2%
No seroprotection
15
  78.9%
23
  95.8%
Day 28 Seroprotection
11
  57.9%
3
  12.5%
No seroprotection
8
  42.1%
21
  87.5%
Day 56 Seroprotection
14
  73.7%
7
  29.2%
No seroprotection
5
  26.3%
17
  70.8%
14.Primary Outcome
Title 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)
Hide Description Seroprotection 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
5
  26.3%
1
   4.2%
No seroprotection
14
  73.7%
23
  95.8%
Day 28 Seroprotection
11
  57.9%
3
  12.5%
No seroprotection
8
  42.1%
21
  87.5%
Day 56 Seroprotection
14
  73.7%
7
  29.2%
No seroprotection
5
  26.3%
17
  70.8%
15.Primary Outcome
Title 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)
Hide Description Seroprotection 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
2
  10.5%
2
   8.3%
No seroprotection
17
  89.5%
22
  91.7%
Day 28 Seroprotection
12
  63.2%
4
  16.7%
No seroprotection
7
  36.8%
20
  83.3%
Day 56 Seroprotection
14
  73.7%
9
  37.5%
No seroprotection
5
  26.3%
15
  62.5%
16.Primary Outcome
Title 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)
Hide Description Seroprotection 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
5
  26.3%
1
   4.2%
No seroprotection
14
  73.7%
23
  95.8%
Day 28 Seroprotection
11
  57.9%
4
  16.7%
No seroprotection
8
  42.1%
20
  83.3%
Day 56 Seroprotection
14
  73.7%
8
  33.3%
No seroprotection
5
  26.3%
16
  66.7%
17.Primary Outcome
Title 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)
Hide Description Serum 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
15
  78.9%
7
  29.2%
No seroprotection
4
  21.1%
17
  70.8%
Day 28 Seroprotection
19
 100.0%
14
  58.3%
No seroprotection
0
   0.0%
10
  41.7%
Day 56 Seroprotection
19
 100.0%
22
  91.7%
No seroprotection
0
   0.0%
2
   8.3%
18.Primary Outcome
Title 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)
Hide Description Serum 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroprotection
12
  63.2%
6
  25.0%
No seroprotection
7
  36.8%
18
  75.0%
Day 28 Seroprotection
17
  89.5%
11
  45.8%
No seroprotection
2
  10.5%
13
  54.2%
Day 56 Seroprotection
19
 100.0%
21
  87.5%
No seroprotection
0
   0.0%
3
  12.5%
19.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (Standard Deviation)
Unit of Measure: titer
Day 0 4.5  (1.4) 4.0  (1.7)
Day 7 6.2  (1.9) 5.0  (1.4)
Day 28 6.8  (1.5) 5.3  (1.5)
Day 56 6.7  (1.4) 5.2  (1.7)
20.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (Standard Deviation)
Unit of Measure: titer
Day 0 2.5  (0.8) 2.5  (1.2)
Day 7 5.3  (2.4) 4.1  (1.5)
Day 28 5.6  (2.3) 3.9  (2.1)
Day 56 5.6  (1.9) 4.2  (2.1)
21.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (Standard Deviation)
Unit of Measure: titer
Day 0 9.7  (0.9) 9.0  (1.1)
Day 7 10.4  (1.1) 9.7  (1.2)
Day 28 11.2  (1.1) 10.2  (1.3)
Day 56 11.3  (0.9) 10.6  (1.0)
22.Primary Outcome
Title 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)
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Geometric Mean (Standard Deviation)
Unit of Measure: titer
Day 0 8.3  (1.1) 9.5  (1.1)
Day 7 10.4  (1.1) 9.7  (1.2)
Day 28 11.2  (1.1) 10.2  (1.3)
Day 56 10.3  (0.9) 9.2  (1.3)
23.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
9
  47.4%
8
  33.3%
No seroconversion
10
  52.6%
16
  66.7%
Day 28 Seroconversion
13
  68.4%
9
  37.5%
No seroconversion
6
  31.6%
15
  62.5%
Day 56 Seroconversion
13
  68.4%
9
  37.5%
No seroconversion
6
  31.6%
15
  62.5%
24.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
15
  78.9%
12
  50.0%
No seroconversion
4
  21.1%
12
  50.0%
Day 28 Seroconversion
15
  78.9%
11
  45.8%
No seroconversion
4
  21.1%
13
  54.2%
Day 56 Seroconversion
15
  78.9%
13
  54.2%
No seroconversion
4
  21.1%
11
  45.8%
25.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
3
  15.8%
4
  16.7%
No seroconversion
16
  84.2%
20
  83.3%
Day 28 Seroconversion
9
  47.4%
7
  29.2%
No seroconversion
10
  52.6%
17
  70.8%
Day 56 Seroconversion
10
  52.6%
10
  41.7%
No seroconversion
9
  47.4%
14
  58.3%
26.Primary Outcome
Title 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)
Hide Description A 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Seroconversion
5
  26.3%
6
  25.0%
No seroconversion
14
  73.7%
18
  75.0%
Day 28 Seroconversion
11
  57.9%
11
  45.8%
No seroconversion
8
  42.1%
13
  54.2%
Day 56 Seroconversion
11
  57.9%
15
  62.5%
No seroconversion
8
  42.1%
9
  37.5%
27.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Number Analyzed 14 participants 9 participants
Yes
6
  42.9%
2
  22.2%
No
8
  57.1%
7
  77.8%
Day 28 Number Analyzed 14 participants 9 participants
Yes
5
  35.7%
1
  11.1%
No
9
  64.3%
8
  88.9%
28.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 11
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Yes
5
  45.5%
1
   9.1%
No
6
  54.5%
10
  90.9%
Day 28 Yes
6
  54.5%
1
   9.1%
No
5
  45.5%
10
  90.9%
29.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Yes
9
  52.9%
3
  18.8%
No
8
  47.1%
13
  81.3%
Day 28 Yes
7
  41.2%
0
   0.0%
No
10
  58.8%
16
 100.0%
30.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 17
Measure Type: Count of Participants
Unit of Measure: Participants
Day 7 Yes
2
  18.2%
0
   0.0%
No
9
  81.8%
17
 100.0%
Day 28 Yes
6
  54.5%
3
  17.6%
No
5
  45.5%
14
  82.4%
31.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 14 9
Mean (Standard Deviation)
Unit of Measure: avidity index
Day 0 75.6  (14.6) 75.2  (8.6)
Day 7 87.7  (9.3) 81.5  (10.3)
Day 28 87.2  (8.6) 85.1  (7.8)
32.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: avidity index
Day 0 81.6  (11.8) 83.4  (9.7)
Day 7 90.7  (5.7) 86.0  (12.0)
Day 28 92.3  (6.4) 84.2  (10.5)
33.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: avidity index
Day 0 72.7  (7.5) 77.4  (6.4)
Day 7 86.4  (12.6) 83.3  (8.1)
Day 28 84.9  (8.8) 77.9  (8.3)
34.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with seroconversion were included in the analysis.
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 11 17
Mean (Standard Deviation)
Unit of Measure: avidity index
Day 0 76.2  (4.9) 78.3  (8.2)
Day 7 86.2  (10.6) 78.0  (9.1)
Day 28 90.6  (14.2) 77.9  (15.8)
35.Other Pre-specified Outcome
Title Number of Subjects Experiencing Adverse Events After Receiving A(H5N1) Inactivated Influenza Vaccine
Hide Description 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.
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Post-dose 1 Mild
13
  68.4%
14
  58.3%
Moderate
0
   0.0%
1
   4.2%
None
6
  31.6%
9
  37.5%
Post-dose 2 Mild
9
  47.4%
3
  12.5%
Moderate
1
   5.3%
1
   4.2%
None
9
  47.4%
20
  83.3%
36.Other Pre-specified Outcome
Title Number of Subjects Experiencing Any Adverse Event Related to the A(H5N1) Inactivated Influenza Vaccine
Hide Description 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
Time Frame 56 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 19 24
Measure Type: Count of Participants
Unit of Measure: Participants
Post-dose 1 Experienced treatment-related adverse event
11
  57.9%
9
  37.5%
Did not experience treatment-related adverse event
8
  42.1%
15
  62.5%
Post-dose 2 Experienced treatment-related adverse event
9
  47.4%
4
  16.7%
Did not experience treatment-related adverse event
10
  52.6%
20
  83.3%
Time Frame 56 days
Adverse Event Reporting Description 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
 
Arm/Group Title H5N2 Primed Control
Hide Arm/Group Description

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

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.

All-Cause Mortality
H5N2 Primed Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
H5N2 Primed Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
H5N2 Primed Control
Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   15/24 (62.50%) 
Gastrointestinal disorders     
Oropharyngeal pain  1  1/19 (5.26%)  0/24 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/19 (5.26%)  0/24 (0.00%) 
Aspartate aminotransferase increased  1  1/19 (5.26%)  0/24 (0.00%) 
Bilirubin increased  1  0/19 (0.00%)  4/24 (16.67%) 
Blood creatinine increased  1  3/19 (15.79%)  1/24 (4.17%) 
Eosinophil count increased  1  8/19 (42.11%)  4/24 (16.67%) 
Lymphocyte count increased  1  5/19 (26.32%)  1/24 (4.17%) 
Lymphocyte count decreased  1  8/19 (42.11%)  6/24 (25.00%) 
Monocyte count increased  1  4/19 (21.05%)  5/24 (20.83%) 
Neutrophil count increased  1  7/19 (36.84%)  8/24 (33.33%) 
Neutrophil count decreased  1  7/19 (36.84%)  8/24 (33.33%) 
White blood cells count increased  1  1/19 (5.26%)  2/24 (8.33%) 
Nervous system disorders     
Headache  1  0/19 (0.00%)  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/19 (5.26%)  0/24 (0.00%) 
Nasopharyngitis  1  1/19 (5.26%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritis  1  0/19 (0.00%)  1/24 (4.17%) 
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jorge Flores
Organization: PATH
Phone: (202) 822-0033
EMail: jeflores@path.org
Layout table for additonal information
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT02153671     History of Changes
Other Study ID Numbers: LAIV-H5N2-02
First Submitted: May 23, 2014
First Posted: June 3, 2014
Results First Submitted: August 7, 2018
Results First Posted: February 18, 2019
Last Update Posted: February 18, 2019