Trial Outcomes & Findings for Reverse Genetic H9N2 Influenza Vaccine Study in Adults (NCT NCT01320696)
NCT ID: NCT01320696
Last Updated: 2023-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
353 participants
Primary outcome timeframe
21 days after 2nd vaccination
Results posted on
2023-02-16
Participant Flow
Of the 353 enrolled participants, 275 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
3.75 µg
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
56
|
55
|
54
|
55
|
55
|
|
Overall Study
Vaccinated Vacc. 1
|
56
|
55
|
54
|
55
|
55
|
|
Overall Study
Vaccinated Vacc. 2
|
53
|
53
|
54
|
55
|
54
|
|
Overall Study
COMPLETED
|
51
|
51
|
51
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
3
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reverse Genetic H9N2 Influenza Vaccine Study in Adults
Baseline characteristics by cohort
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
Total
n=275 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
32.6 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 9.3 • n=4 Participants
|
34.1 years
STANDARD_DEVIATION 9.0 • n=21 Participants
|
33.8 years
STANDARD_DEVIATION 8.8 • n=10 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
151 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
124 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
19 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
256 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
47 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
217 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 21 days after 2nd vaccinationOutcome measures
| Measure |
3.75 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=53 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=53 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With a Hemagglutination Inhibition (HI) Antibody Response to the Vaccine Strain (A/H9N2/Chicken/Hong Kong/G9/97) Associated With Seroconversion 21 Days After the Second Vaccination
|
27 Participants
|
27 Participants
|
38 Participants
|
41 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 21 days after 2nd vaccinationOutcome measures
| Measure |
3.75 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=53 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=53 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the Second Vaccination
|
28 Participants
|
28 Participants
|
39 Participants
|
42 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 7 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 1st vaccination : Mild
|
9 participants
|
10 participants
|
16 participants
|
17 participants
|
20 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 1st vaccination : Moderate
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 1st vaccination : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 1st vaccination : Unknown
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 2nd vaccination : Mild
|
6 participants
|
8 participants
|
14 participants
|
10 participants
|
18 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 2nd vaccination : Moderate
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 2nd vaccination : Severe
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with injection site reactions within 7 days after 2nd vaccination : Unknown
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 1st vaccination : Mild
|
6 participants
|
13 participants
|
12 participants
|
10 participants
|
11 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 1st vaccination: Moderate
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 1st vaccination : Severe
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 1st vaccination : Unknown
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 2nd vaccination : Mild
|
3 participants
|
3 participants
|
7 participants
|
4 participants
|
3 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 2nd vaccination: Moderate
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 2nd vaccination : Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Subjects With Injection Site and Systemic Reactions Within 7 Days After the First and Second Vaccination (Vacc) by Severity
Number of subjects with systemic reactions within 7 days after 2nd vaccination : Unknown
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 21 days after 1st vaccinationOutcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects Achieving an HI Antibody Titer >= 1:40 21 Days After the First Vaccination
|
17 Participants
|
22 Participants
|
33 Participants
|
35 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20
21 days after 1st vaccination
|
45 Participants
|
48 Participants
|
49 Participants
|
55 Participants
|
54 Participants
|
|
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Microneutralization (MN) Titer >= 1:20
21 days after 2nd vaccination
|
51 Participants
|
51 Participants
|
50 Participants
|
53 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2
21 days after 1st vaccination
|
45 Participants
|
48 Participants
|
49 Participants
|
53 Participants
|
53 Participants
|
|
Number of Subjects With Antibody Response Associated With Protection 21 Days After the First and Second Vaccination Defined as Single Radial Hemolysis (SRH) Area >= 25 mm2
21 days after 2nd vaccination
|
49 Participants
|
52 Participants
|
51 Participants
|
52 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 2nd vaccination : Measured by MN assay
|
49 Participants
|
49 Participants
|
49 Participants
|
51 Participants
|
53 Participants
|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 1st vaccination : Measured by HI assay
|
16 Participants
|
21 Participants
|
32 Participants
|
35 Participants
|
40 Participants
|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 1st vaccination : Measured by MN assay
|
40 Participants
|
44 Participants
|
47 Participants
|
52 Participants
|
53 Participants
|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 1st vaccination : Measured by SRH area
|
30 Participants
|
39 Participants
|
35 Participants
|
42 Participants
|
42 Participants
|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 2nd vaccination : Measured by HI assay
|
27 Participants
|
27 Participants
|
38 Participants
|
41 Participants
|
48 Participants
|
|
Number of Participants With Antibody Response 21 Days After the First and Second Vaccination Measured by HI, MN and SRH Assays
Antibody response 21 days after the 2nd vaccination : Measured by SRH area
|
35 Participants
|
42 Participants
|
38 Participants
|
43 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 1st vaccination by HI assay
|
3.2 Fold Change in Antibody Response
Interval 2.5 to 4.1
|
4.5 Fold Change in Antibody Response
Interval 3.3 to 6.2
|
7.8 Fold Change in Antibody Response
Interval 5.8 to 10.5
|
10.4 Fold Change in Antibody Response
Interval 7.4 to 14.6
|
15.5 Fold Change in Antibody Response
Interval 11.7 to 20.5
|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 2nd vaccination by HI assay
|
5.7 Fold Change in Antibody Response
Interval 4.5 to 7.2
|
6.6 Fold Change in Antibody Response
Interval 5.0 to 8.7
|
10.7 Fold Change in Antibody Response
Interval 8.0 to 14.2
|
12.7 Fold Change in Antibody Response
Interval 9.7 to 16.8
|
19.8 Fold Change in Antibody Response
Interval 15.5 to 25.3
|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 1st vaccination by MN assay
|
8 Fold Change in Antibody Response
Interval 5.9 to 10.8
|
14.4 Fold Change in Antibody Response
Interval 10.3 to 20.3
|
18.9 Fold Change in Antibody Response
Interval 13.4 to 26.7
|
26.7 Fold Change in Antibody Response
Interval 19.3 to 36.8
|
44.1 Fold Change in Antibody Response
Interval 32.4 to 60.1
|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 2nd vaccination by MN assay
|
22.2 Fold Change in Antibody Response
Interval 17.2 to 28.6
|
25.5 Fold Change in Antibody Response
Interval 18.5 to 34.9
|
34.0 Fold Change in Antibody Response
Interval 25.2 to 45.9
|
38.9 Fold Change in Antibody Response
Interval 28.9 to 52.5
|
67.4 Fold Change in Antibody Response
Interval 51.1 to 88.8
|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 1st vaccination by SRH assay
|
2.7 Fold Change in Antibody Response
Interval 2.2 to 3.3
|
3.9 Fold Change in Antibody Response
Interval 3.0 to 4.9
|
3.2 Fold Change in Antibody Response
Interval 2.5 to 4.0
|
4.0 Fold Change in Antibody Response
Interval 3.2 to 5.1
|
5.1 Fold Change in Antibody Response
Interval 4.0 to 6.6
|
|
Fold Increase of Antibody Response 21 Days After the First and Second Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured after 2nd vaccination by SRH assay
|
3.7 Fold Change in Antibody Response
Interval 2.9 to 4.6
|
4.5 Fold Change in Antibody Response
Interval 3.5 to 5.8
|
3.7 Fold Change in Antibody Response
Interval 2.9 to 4.7
|
4.4 Fold Change in Antibody Response
Interval 3.5 to 5.6
|
5.5 Fold Change in Antibody Response
Interval 4.3 to 7.2
|
SECONDARY outcome
Timeframe: 21 days after 1st vaccinationOutcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Seroconversion (as Defined for the Primary Immunogenicity Endpoint) Measured by HI Assay 21 Days After the First Vaccination as Compared to Baseline
|
16 Participants
|
21 Participants
|
32 Participants
|
35 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline
Number of subjects with seroconversion 21 days after 1st vaccination
|
40 Participants
|
44 Participants
|
47 Participants
|
52 Participants
|
53 Participants
|
|
Number of Subjects With Seroconversion Defined as a Minimum Fourfold Increase in Titer Measured by MN Assay 21 Days After the First and Second Vaccination as Compared to Baseline
Number of subjects with seroconversion 21 days after 2nd vaccination
|
49 Participants
|
49 Participants
|
49 Participants
|
51 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 21 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination
Number of subjects with seroconversion 21 days after the 1st vaccination
|
30 Participants
|
39 Participants
|
35 Participants
|
42 Participants
|
42 Participants
|
|
Number of Subjects With Seroconversion as Measured by SRH Assay 21 Days After the First and Second Vaccination
Number of subjects with seroconversion 21 days after the 2nd vaccination
|
35 Participants
|
42 Participants
|
38 Participants
|
43 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 180 days after 1st vaccinationOutcome measures
| Measure |
3.75 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay
|
10 Participants
|
17 Participants
|
22 Participants
|
28 Participants
|
31 Participants
|
|
Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay
|
38 Participants
|
43 Participants
|
45 Participants
|
49 Participants
|
52 Participants
|
|
Number of Subjects With Antibody Response Associated With Protection 180 Days After the First Vaccination as Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay
|
46 Participants
|
49 Participants
|
50 Participants
|
51 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 180 days after 1st vaccinationOutcome measures
| Measure |
3.75 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by HI Assay
|
9 Participants
|
17 Participants
|
21 Participants
|
28 Participants
|
31 Participants
|
|
Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by MN Assay
|
34 Participants
|
41 Participants
|
44 Participants
|
47 Participants
|
52 Participants
|
|
Number of Subjects With Antibody Response 180 Days After the First Vaccination Measured by HI, MN and SRH Assays
Subjects with antibody response 180 days after the 1st vaccination as measured by SRH Assay
|
30 Participants
|
43 Participants
|
36 Participants
|
43 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 180 days after 1st vaccinationOutcome measures
| Measure |
3.75 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=51 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=52 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured by HI Assay
|
2.7 Fold change in Antibody Response
Interval 2.2 to 3.2
|
3.9 Fold change in Antibody Response
Interval 3.0 to 5.1
|
4.3 Fold change in Antibody Response
Interval 3.4 to 4.6
|
6.1 Fold change in Antibody Response
Interval 4.9 to 7.6
|
8.1 Fold change in Antibody Response
Interval 6.6 to 9.9
|
|
Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured by MN Assay
|
5.4 Fold change in Antibody Response
Interval 4.2 to 7.0
|
9.1 Fold change in Antibody Response
Interval 6.5 to 12.7
|
10.3 Fold change in Antibody Response
Interval 7.9 to 13.3
|
13.3 Fold change in Antibody Response
Interval 10.3 to 17.2
|
19.9 Fold change in Antibody Response
Interval 15.4 to 25.8
|
|
Fold Increase of Antibody Response 180 Days After the First Vaccination as Compared to Baseline Measured by HI, MN and SRH Assays
Fold increase of antibody response measured by SRH Assay
|
3.4 Fold change in Antibody Response
Interval 2.7 to 4.3
|
4.5 Fold change in Antibody Response
Interval 3.5 to 5.8
|
3.7 Fold change in Antibody Response
Interval 2.9 to 4.7
|
4.5 Fold change in Antibody Response
Interval 3.5 to 5.7
|
5.1 Fold change in Antibody Response
Interval 4.0 to 6.6
|
SECONDARY outcome
Timeframe: 7 days after 1st and 2nd vaccinationPopulation: Participant number differs from 1st to 2nd vaccination due to dropouts
Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 1st vaccination : Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 1st vaccination : Malasie
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 1st vaccination : Shivering
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 2nd vaccination : Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 2nd vaccination : Malasie
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Fever, Malaise and Shivering With Onset Within 7 Days After the First and Second Vaccination
After 2nd vaccination : Shivering
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion by all subjects, an average of 181 days (+/- 14 days)Outcome measures
| Measure |
3.75 µg
n=56 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=55 Participants
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period
Mild
|
25 Events
|
54 Events
|
67 Events
|
46 Events
|
64 Events
|
|
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period
Moderate
|
2 Events
|
5 Events
|
7 Events
|
4 Events
|
10 Events
|
|
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period
Severe
|
2 Events
|
0 Events
|
1 Events
|
0 Events
|
0 Events
|
|
Frequency and Severity of Adverse Events (AEs) Observed During the Entire Study Period
Unknown
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
0 Events
|
Adverse Events
3.75 µg
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
7.5 µg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
15 µg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
30 µg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
45 µg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3.75 µg
n=56 participants at risk
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
7.5 µg
n=55 participants at risk
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
15 µg
n=54 participants at risk
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
30 µg
n=55 participants at risk
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
45 µg
n=55 participants at risk
Subjects to receive 2 intramuscular injections of Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine on Day 1 and Day 22
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
1/53
|
1.9%
1/53
|
5.6%
3/54
|
0.00%
0/55
|
1.9%
1/54
|
|
Nervous system disorders
Headache
|
5.7%
3/53
|
1.9%
1/53
|
3.7%
2/54
|
7.3%
4/55
|
1.9%
1/54
|
|
General disorders
Injection Site Reactions
|
13.2%
7/53
|
15.1%
8/53
|
27.8%
15/54
|
21.8%
12/55
|
37.0%
20/54
|
|
General disorders
Fatigue
|
5.4%
3/56
|
16.4%
9/55
|
7.4%
4/54
|
3.6%
2/55
|
3.6%
2/55
|
|
General disorders
Malaise
|
0.00%
0/53
|
3.8%
2/53
|
5.6%
3/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/55
|
|
Investigations
Aspartate aminotransferase
|
1.8%
1/56
|
0.00%
0/55
|
1.9%
1/54
|
1.8%
1/55
|
0.00%
0/55
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/56
|
1.8%
1/55
|
1.9%
1/54
|
0.00%
0/55
|
1.8%
1/55
|
|
General disorders
Asthenia
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/55
|
|
General disorders
Chest pain
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/55
|
|
General disorders
Chills
|
0.00%
0/56
|
3.6%
2/55
|
0.00%
0/54
|
0.00%
0/55
|
3.6%
2/55
|
|
General disorders
Hyperhidrosis
|
0.00%
0/53
|
0.00%
0/53
|
3.7%
2/54
|
0.00%
0/55
|
0.00%
0/54
|
|
General disorders
General pain
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/55
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/56
|
1.8%
1/55
|
0.00%
0/54
|
0.00%
0/55
|
0.00%
0/55
|
|
Infections and infestations
Oral herpes
|
0.00%
0/56
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/55
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/56
|
0.00%
0/55
|
1.9%
1/54
|
1.8%
1/55
|
1.8%
1/55
|
|
Investigations
White blood cell count decreased
|
0.00%
0/56
|
0.00%
0/55
|
1.9%
1/54
|
1.8%
1/55
|
0.00%
0/55
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/53
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/53
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
General disorders
Pyrexia
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
General disorders
Feeling abnormal
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Investigations
Blood creatinine increased
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/56
|
0.00%
0/55
|
0.00%
0/54
|
0.00%
0/55
|
1.8%
1/55
|
|
Eye disorders
Fatigue
|
1.9%
1/53
|
5.7%
3/53
|
5.6%
3/54
|
1.8%
1/55
|
3.7%
2/54
|
|
General disorders
Irritability
|
0.00%
0/53
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Nervous system disorders
Dizziness
|
0.00%
0/53
|
0.00%
0/53
|
3.7%
2/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/53
|
0.00%
0/53
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/54
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/53
|
0.00%
0/53
|
0.00%
0/54
|
1.8%
1/55
|
0.00%
0/54
|
|
Investigations
Body temp increased
|
0.00%
0/56
|
0.00%
0/55
|
1.9%
1/54
|
0.00%
0/55
|
0.00%
0/55
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place