Trial Outcomes & Findings for Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine (NCT NCT01719783)
NCT ID: NCT01719783
Last Updated: 2018-11-28
Results Overview
Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
6 days
Results posted on
2018-11-28
Participant Flow
Participant milestones
| Measure |
LAIV H5N2
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
|
Placebo
two doses of placebo solution provided intranasally
|
|---|---|---|
|
Dose 1
STARTED
|
30
|
10
|
|
Dose 1
COMPLETED
|
30
|
10
|
|
Dose 1
NOT COMPLETED
|
0
|
0
|
|
Dose 2
STARTED
|
30
|
10
|
|
Dose 2
COMPLETED
|
29
|
10
|
|
Dose 2
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
LAIV H5N2
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
|
Placebo
two doses of placebo solution provided intranasally
|
|---|---|---|
|
Dose 2
Physician Decision
|
1
|
0
|
Baseline Characteristics
Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine
Baseline characteristics by cohort
| Measure |
LAIV H5N2
n=30 Participants
Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
|
Placebo
n=10 Participants
two doses of placebo solution intranasal
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
30 participants
n=5 Participants
|
10 participants
n=7 Participants
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 daysPopulation: All participants that received either a vaccine or placebo, by dose
Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Adverse Events by Severity
Worst grade: moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adverse Events by Severity
Worst grade: mild
|
20 Participants
|
8 Participants
|
25 Participants
|
8 Participants
|
—
|
—
|
|
Adverse Events by Severity
Worst grade: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Adverse Events by Severity
None
|
9 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)
Seroconversion
|
4 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)
No seroconversion
|
26 Participants
|
10 Participants
|
18 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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).
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Serum Neutralizing Antibodies
Seroconversion
|
3 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Serum Neutralizing Antibodies
No seroconversion
|
27 Participants
|
10 Participants
|
15 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)
Seroconversion
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)
No seroconversion
|
30 Participants
|
10 Participants
|
27 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Determined using ELISA using whole purified H5N2.
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)
Seroconversion
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)
No seroconversion
|
30 Participants
|
10 Participants
|
28 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Seroconversion for Secretory IgA
Seroconversion
|
2 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Seroconversion for Secretory IgA
No seroconversion
|
28 Participants
|
10 Participants
|
23 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects With Seroconversion for IgA in Saliva
Seroconversion
|
3 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
—
|
—
|
|
Number/Percentage of Subjects With Seroconversion for IgA in Saliva
No seroconversion
|
27 Participants
|
10 Participants
|
19 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 days post-vaccinationPopulation: Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=30 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=30 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=30 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=30 Participants
Received Dose 2 of placebo
|
Day 5
n=30 Participants
Shedding 5 days after dose was administered
|
Day 6
n=30 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose
No shedding
|
2 Participants
|
25 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
30 Participants
|
|
Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose
Shedding
|
28 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 days post-vaccinationPopulation: Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured
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).
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=29 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=29 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=29 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose
Shedding
|
21 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose
No shedding
|
8 Participants
|
25 Participants
|
29 Participants
|
29 Participants
|
29 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Geometric mean titers for serum hemagglutination inhibition antibodies
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
Received Dose 2 of vaccine
|
Dose 2: Placebo
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers for Serum HAI Antibodies
Day 0
|
2.5 titer
Interval 2.5 to 2.5
|
2.7 titer
Interval 2.3 to 3.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers for Serum HAI Antibodies
After dose 1
|
3.5 titer
Interval 2.9 to 4.2
|
2.7 titer
Interval 2.3 to 3.1
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers for Serum HAI Antibodies
After dose 2
|
4.7 titer
Interval 3.6 to 6.1
|
2.9 titer
Interval 2.1 to 3.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0 days, 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
Received Dose 2 of vaccine
|
Dose 2: Placebo
Received Dose 2 of placebo
|
Day 5
Shedding 5 days after dose was administered
|
Day 6
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies
Day 0
|
5.2 titer
Interval 4.9 to 5.6
|
5.4 titer
Interval 4.6 to 6.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies
After dose 1
|
6.7 titer
Interval 5.6 to 8.0
|
5.4 titer
Interval 4.6 to 6.3
|
—
|
—
|
—
|
—
|
|
Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies
After dose 2
|
11.8 titer
Interval 8.7 to 16.0
|
5.7 titer
Interval 4.7 to 7.1
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses
Positive response
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses
No response
|
28 Participants
|
10 Participants
|
27 Participants
|
10 Participants
|
26 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=30 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses
Positive response
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses
No response
|
26 Participants
|
10 Participants
|
25 Participants
|
10 Participants
|
23 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses
No response
|
23 Participants
|
10 Participants
|
26 Participants
|
10 Participants
|
21 Participants
|
10 Participants
|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses
Positive response
|
6 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses
Positive response
|
5 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses
No response
|
24 Participants
|
10 Participants
|
23 Participants
|
10 Participants
|
21 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses
Positive response
|
5 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses
No response
|
24 Participants
|
10 Participants
|
23 Participants
|
10 Participants
|
18 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 28 days (Dose 1) and 56 days (Dose 2)Population: Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured
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.
Outcome measures
| Measure |
Dose 1: Vaccine
n=29 Participants
Received dose 1 of vaccine
|
Dose 1: Placebo
n=10 Participants
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=29 Participants
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 Participants
Received Dose 2 of placebo
|
Day 5
n=29 Participants
Shedding 5 days after dose was administered
|
Day 6
n=10 Participants
Shedding 6 days after dose was administered
|
|---|---|---|---|---|---|---|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses
Positive response
|
2 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses
No response
|
27 Participants
|
9 Participants
|
23 Participants
|
7 Participants
|
26 Participants
|
10 Participants
|
Adverse Events
Dose 1: Vaccine
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Dose 1: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Dose 2: Vaccine
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Dose 2: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose 1: Vaccine
n=30 participants at risk
Received dose 1 of vaccine
|
Dose 1: Placebo
n=30 participants at risk；n=10 participants at risk
Received Dose 1 of Placebo
|
Dose 2: Vaccine
n=30 participants at risk；n=29 participants at risk
Received Dose 2 of vaccine
|
Dose 2: Placebo
n=10 participants at risk
Received Dose 2 of placebo
|
|---|---|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
10.0%
1/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Alkaline Phopsphatase Decreased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
10.0%
1/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Bicarbonate Increased
|
46.7%
14/30 • Within 7 days of administration of dose
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.
|
23.3%
7/30 • Within 7 days of administration of dose
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.
|
50.0%
15/30 • Within 7 days of administration of dose
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.
|
40.0%
4/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Bilirubin Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Calcium Increased
|
16.7%
5/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
13.3%
4/30 • Within 7 days of administration of dose
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.
|
10.0%
1/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Potassium Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Haemoglobin Increased
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
6.7%
2/30 • Within 7 days of administration of dose
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.
|
23.3%
7/30 • Within 7 days of administration of dose
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.
|
20.0%
2/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Lymphocyte Count Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
33.3%
10/30 • Within 7 days of administration of dose
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.
|
30.0%
3/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Monocyte Count Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
10.0%
1/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Red Blood Cell Count Decreased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
White Blood Cell Count Increased
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
6.7%
2/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
20.0%
6/30 • Within 7 days of administration of dose
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.
|
10.0%
1/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Haematocrit Decreased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
13.3%
4/30 • Within 7 days of administration of dose
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.
|
20.0%
2/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Mean Cell Haemoglobin Concentraion Increased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
6.7%
2/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Mean Cell Volume Decreased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Mean Platelet Volume Decreased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Protein Total Increased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
3.3%
1/30 • Within 7 days of administration of dose
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.
|
0.00%
0/10 • Within 7 days of administration of dose
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.
|
|
Investigations
Red Blood Cell Sedimentation Decreased
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
6.7%
2/30 • Within 7 days of administration of dose
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.
|
20.0%
2/10 • Within 7 days of administration of dose
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.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
0.00%
0/30 • Within 7 days of administration of dose
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.
|
10.0%
3/30 • Within 7 days of administration of dose
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.
|
50.0%
5/10 • Within 7 days of administration of dose
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place