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Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01719783
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Collaborators:
Microgen Scientific Industrial Company for Immunobiological Medicines
Institute of Experimental Medicine, Russia
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: LAIV H5N2
Other: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LAIV H5N2 Placebo
Hide Arm/Group Description Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally two doses of placebo solution provided intranasally
Period Title: Dose 1
Started 30 10
Completed 30 10
Not Completed 0 0
Period Title: Dose 2
Started 30 10
Completed 29 10
Not Completed 1 0
Reason Not Completed
Physician Decision             1             0
Arm/Group Title LAIV H5N2 Placebo Total
Hide Arm/Group Description Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally two doses of placebo solution intranasal Total of all reporting groups
Overall Number of Baseline Participants 30 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 10 participants 40 participants
27.7  (10.4) 29.2  (10.8) 28.1  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 10 participants 40 participants
Female
9
  30.0%
4
  40.0%
13
  32.5%
Male
21
  70.0%
6
  60.0%
27
  67.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russia Number Analyzed 30 participants 10 participants 40 participants
30 10 40
1.Primary Outcome
Title Adverse Events by Severity
Hide Description Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
Time Frame 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that received either a vaccine or placebo, by dose
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Worst grade: mild
20
  66.7%
8
  80.0%
25
  86.2%
8
  80.0%
Worst grade: moderate
1
   3.3%
0
   0.0%
0
   0.0%
0
   0.0%
Worst grade: severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
None
9
  30.0%
2
  20.0%
4
  13.8%
2
  20.0%
2.Secondary Outcome
Title Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)
Hide Description

Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.

HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
4
  13.3%
0
   0.0%
11
  37.9%
0
   0.0%
No seroconversion
26
  86.7%
10
 100.0%
18
  62.1%
10
 100.0%
3.Secondary Outcome
Title Number/Percentage of Subjects With Serum Neutralizing Antibodies
Hide Description

Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.

Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
3
  10.0%
0
   0.0%
14
  48.3%
0
   0.0%
No seroconversion
27
  90.0%
10
 100.0%
15
  51.7%
10
 100.0%
4.Secondary Outcome
Title Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)
Hide Description IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2
Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
0
   0.0%
0
   0.0%
2
   6.9%
0
   0.0%
No seroconversion
30
 100.0%
10
 100.0%
27
  93.1%
10
 100.0%
5.Secondary Outcome
Title Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)
Hide Description Determined using ELISA using whole purified H5N2.
Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
0
   0.0%
0
   0.0%
1
   3.4%
0
   0.0%
No seroconversion
30
 100.0%
10
 100.0%
28
  96.6%
10
 100.0%
6.Secondary Outcome
Title Number/Percentage of Subjects With Seroconversion for Secretory IgA
Hide Description IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2
Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
2
   6.7%
0
   0.0%
6
  20.7%
0
   0.0%
No seroconversion
28
  93.3%
10
 100.0%
23
  79.3%
10
 100.0%
7.Secondary Outcome
Title Number/Percentage of Subjects With Seroconversion for IgA in Saliva
Hide Description IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.
Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Overall Number of Participants Analyzed 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Seroconversion
3
  10.0%
0
   0.0%
10
  34.5%
0
   0.0%
No seroconversion
27
  90.0%
10
 100.0%
19
  65.5%
10
 100.0%
8.Secondary Outcome
Title Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose
Hide Description Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.
Time Frame 6 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured
Arm/Group Title Day 1 Day 2 Day 3 Day 4 Day 5 Day 6
Hide Arm/Group Description:
Shedding 1 day after first dose was administered
Shedding 2 days after first dose was administered
Shedding 3 days after dose was administered
Shedding 4 days after dose was administered
Shedding 5 days after dose was administered
Shedding 6 days after dose was administered
Overall Number of Participants Analyzed 30 30 30 30 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
Shedding
28
  93.3%
5
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
No shedding
2
   6.7%
25
  83.3%
30
 100.0%
30
 100.0%
30
 100.0%
30
 100.0%
9.Secondary Outcome
Title Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose
Hide Description Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).
Time Frame 6 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured
Arm/Group Title Day 1 Day 2 Day 3 Day 4 Day 5 Day 6
Hide Arm/Group Description:
Shedding 1 day after first dose was administered
Shedding 2 days after first dose was administered
Shedding 3 days after dose was administered
Shedding 4 days after dose was administered
Shedding 5 days after dose was administered
Shedding 6 days after dose was administered
Overall Number of Participants Analyzed 29 29 29 29 29 29
Measure Type: Count of Participants
Unit of Measure: Participants
Shedding
21
  72.4%
4
  13.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
No shedding
8
  27.6%
25
  86.2%
29
 100.0%
29
 100.0%
29
 100.0%
29
 100.0%
10.Secondary Outcome
Title Geometric Mean Titers for Serum HAI Antibodies
Hide Description Geometric mean titers for serum hemagglutination inhibition antibodies
Time Frame 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title LAIV H5N2 Placebo
Hide Arm/Group Description:
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
two doses of placebo solution provided intranasally
Overall Number of Participants Analyzed 29 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
2.5
(2.5 to 2.5)
2.7
(2.3 to 3.1)
After dose 1
3.5
(2.9 to 4.2)
2.7
(2.3 to 3.1)
After dose 2
4.7
(3.6 to 6.1)
2.9
(2.1 to 3.9)
11.Secondary Outcome
Title Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies
Hide Description Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay
Time Frame 0 days, 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title LAIV H5N2 Placebo
Hide Arm/Group Description:
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
two doses of placebo solution provided intranasally
Overall Number of Participants Analyzed 29 10
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0
5.2
(4.9 to 5.6)
5.4
(4.6 to 6.3)
After dose 1
6.7
(5.6 to 8.0)
5.4
(4.6 to 6.3)
After dose 2
11.8
(8.7 to 16)
5.7
(4.7 to 7.1)
12.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
Received dose 1 of vaccine
Received Dose 1 of Placebo
Received Dose 2 of vaccine
Received Dose 2 of placebo
Received dose 1 or 2 of vaccine
Received dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 29 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
1
   3.4%
0
   0.0%
2
   6.9%
0
   0.0%
3
  10.3%
0
   0.0%
No response
28
  96.6%
10
 100.0%
27
  93.1%
10
 100.0%
26
  89.7%
10
 100.0%
13.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
After receiving dose 1 of vaccine
After receiving Dose 1 of Placebo
After receiving Dose 2 of vaccine
After receiving Dose 2 of placebo
Received dose 1 or 2 of vaccine
Received dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 30 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
3
  10.3%
0
   0.0%
5
  16.7%
0
   0.0%
6
  20.7%
0
   0.0%
No response
26
  89.7%
10
 100.0%
25
  83.3%
10
 100.0%
23
  79.3%
10
 100.0%
14.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
After receiving dose 1 of vaccine
After receiving Dose 1 of Placebo
After receiving Dose 2 of vaccine
After receiving Dose 2 of placebo
Received dose 1 or 2 of vaccine
Received dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 29 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
6
  20.7%
0
   0.0%
3
  10.3%
0
   0.0%
8
  27.6%
0
   0.0%
No response
23
  79.3%
10
 100.0%
26
  89.7%
10
 100.0%
21
  72.4%
10
 100.0%
15.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
After receiving dose 1 of vaccine
After receiving Dose 1 of Placebo
After receiving Dose 2 of vaccine
After receiving Dose 2 of placebo
Received dose 1 or 2 of vaccine
Received dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 29 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
5
  17.2%
0
   0.0%
6
  20.7%
0
   0.0%
8
  27.6%
0
   0.0%
No response
24
  82.8%
10
 100.0%
23
  79.3%
10
 100.0%
21
  72.4%
10
 100.0%
16.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
After receiving dose 1 of vaccine
After receiving Dose 1 of Placebo
After receiving Dose 2 of vaccine
After receiving Dose 2 of placebo
After receiving dose 1 or 2 of vaccine
After receiving dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 29 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
5
  17.2%
0
   0.0%
6
  20.7%
0
   0.0%
11
  37.9%
0
   0.0%
No response
24
  82.8%
10
 100.0%
23
  79.3%
10
 100.0%
18
  62.1%
10
 100.0%
17.Other Pre-specified Outcome
Title Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses
Hide Description

Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.

An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.

Time Frame 28 days (Dose 1) and 56 days (Dose 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo Dose 1 or 2: Vaccine Dose 1 or 2: Placebo
Hide Arm/Group Description:
After receiving dose 1 of vaccine
After receiving Dose 1 of Placebo
After receiving Dose 2 of vaccine
After receiving Dose 2 of placebo
Received dose 1 or 2 of vaccine
Received dose 1 or 2 of placebo
Overall Number of Participants Analyzed 29 10 29 10 29 10
Measure Type: Count of Participants
Unit of Measure: Participants
Positive response
2
   6.9%
1
  10.0%
6
  20.7%
3
  30.0%
3
  10.3%
0
   0.0%
No response
27
  93.1%
9
  90.0%
23
  79.3%
7
  70.0%
26
  89.7%
10
 100.0%
Time Frame Within 7 days of administration of dose
Adverse Event Reporting Description

Definition of adverse event does not differ from clinicaltrials.gov.

Adverse events occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. This includes abnormal laboratory findings from blood and urine specimens collected on Days 6 and 34.

 
Arm/Group Title Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Hide Arm/Group Description Received dose 1 of vaccine Received Dose 1 of Placebo Received Dose 2 of vaccine Received Dose 2 of placebo
All-Cause Mortality
Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/10 (0.00%)   0/29 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/10 (0.00%)   0/29 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dose 1: Vaccine Dose 1: Placebo Dose 2: Vaccine Dose 2: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   21/30 (70.00%)   8/30 (26.67%)   25/30 (83.33%)   8/10 (80.00%) 
Investigations         
Alanine Aminotransferase Increased  1  1/30 (3.33%)  1/30 (3.33%)  3/30 (10.00%)  1/10 (10.00%) 
Aspartate Aminotransferase Increased  1  1/30 (3.33%)  1/30 (3.33%)  1/30 (3.33%)  0/10 (0.00%) 
Blood Alkaline Phopsphatase Decreased  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  1/10 (10.00%) 
Blood Bicarbonate Increased  1  14/30 (46.67%)  7/30 (23.33%)  15/30 (50.00%)  4/10 (40.00%) 
Blood Bilirubin Increased  1  1/30 (3.33%)  0/30 (0.00%)  3/30 (10.00%)  0/10 (0.00%) 
Blood Calcium Increased  1  5/30 (16.67%)  1/30 (3.33%)  4/30 (13.33%)  1/10 (10.00%) 
Blood Potassium Increased  1  1/30 (3.33%)  0/30 (0.00%)  0/30 (0.00%)  0/10 (0.00%) 
Haemoglobin Increased  1  3/30 (10.00%)  2/30 (6.67%)  7/30 (23.33%)  2/10 (20.00%) 
Lymphocyte Count Increased  1  1/30 (3.33%)  0/30 (0.00%)  10/30 (33.33%)  3/10 (30.00%) 
Monocyte Count Increased  1  1/30 (3.33%)  0/30 (0.00%)  3/30 (10.00%)  1/10 (10.00%) 
Red Blood Cell Count Decreased  1  1/30 (3.33%)  0/30 (0.00%)  3/30 (10.00%)  0/10 (0.00%) 
White Blood Cell Count Increased  1  1/30 (3.33%)  0/30 (0.00%)  2/30 (6.67%)  0/10 (0.00%) 
Blood Glucose Increased  1  0/30 (0.00%)  0/30 (0.00%)  6/30 (20.00%)  1/10 (10.00%) 
Haematocrit Decreased  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/10 (0.00%) 
Haemoglobin Decreased  1  0/30 (0.00%)  0/30 (0.00%)  4/30 (13.33%)  2/10 (20.00%) 
Mean Cell Haemoglobin Concentraion Increased  1  0/30 (0.00%)  0/30 (0.00%)  2/30 (6.67%)  0/10 (0.00%) 
Mean Cell Volume Decreased  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/10 (0.00%) 
Mean Platelet Volume Decreased  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/10 (0.00%) 
Protein Total Increased  1  0/30 (0.00%)  0/30 (0.00%)  1/30 (3.33%)  0/10 (0.00%) 
Red Blood Cell Sedimentation Decreased  1  0/30 (0.00%)  0/30 (0.00%)  2/30 (6.67%)  2/10 (20.00%) 
Renal and urinary disorders         
Proteinuria  1  0/30 (0.00%)  0/30 (0.00%)  3/30 (10.00%)  5/10 (50.00%) 
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: NCT01719783     History of Changes
Other Study ID Numbers: LAIV-H5N2-01
First Submitted: October 26, 2012
First Posted: November 1, 2012
Results First Submitted: April 9, 2018
Results First Posted: November 28, 2018
Last Update Posted: November 28, 2018