Trial Outcomes & Findings for Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children (NCT NCT02649192)
NCT ID: NCT02649192
Last Updated: 2019-10-29
Results Overview
The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Day 56 after vaccination
Results posted on
2019-10-29
Participant Flow
Participant milestones
| Measure |
A&D - S1
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
22
|
22
|
12
|
14
|
|
Overall Study
Vitamin A Sufficiency (RBP≥22,000 ng/ml)
|
2
|
2
|
11
|
12
|
7
|
8
|
|
Overall Study
Vitamin A Insufficiency (RBP<22,000 ng/m
|
3
|
2
|
11
|
10
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
21
|
20
|
11
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Baseline characteristics by cohort
| Measure |
A&D-S1
n=5 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=22 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=22 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=12 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
7 years
n=5 Participants
|
3.5 years
n=7 Participants
|
5 years
n=5 Participants
|
4 years
n=4 Participants
|
3 years
n=21 Participants
|
5 years
n=8 Participants
|
5 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
78 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
22 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
79 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 56 after vaccinationPopulation: All enrolled subjects who satisfied the inclusion/exclusion criteria were included in the analysis. For the four participants who didn't complete the study, results after one immunization were used.
The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.
Outcome measures
| Measure |
A&D - S1
n=5 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=22 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=22 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=12 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 56 after vaccinationPopulation: Subjects with complete isotype data at day 56. Subjects with an undetermined assay result were not included in analyses. In some cases, the limit of detection (LOD) for the assay was reached and that LOD value was used in calculations.
Isotype ratios will be summarized with descriptive statistics.
Outcome measures
| Measure |
A&D - S1
n=5 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=20 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=20 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=11 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Isotype Ratios on Day 56
IgA/IgM
|
2.48 ratio
Interval 0.16 to 2.8
|
1.37 ratio
Interval 0.83 to 2.89
|
1.21 ratio
Interval 0.03 to 3.06
|
1.21 ratio
Interval 0.45 to 2.88
|
0.86 ratio
Interval 0.23 to 1.9
|
1 ratio
Interval 0.14 to 3.26
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Isotype Ratios on Day 56
IgA/IgG1
|
0.4 ratio
Interval 0.06 to 0.67
|
0.3 ratio
Interval 0.22 to 0.5
|
0.3 ratio
Interval 0.004 to 0.63
|
0.27 ratio
Interval 0.13 to 0.47
|
0.21 ratio
Interval 0.13 to 0.65
|
0.28 ratio
Interval 0.12 to 0.87
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Isotype Ratios on Day 56
IgA/IgG2
|
0.71 ratio
Interval 0.24 to 0.85
|
0.69 ratio
Interval 0.49 to 1.93
|
0.96 ratio
Interval 0.004 to 6.3
|
1.13 ratio
Interval 0.58 to 4.45
|
0.65 ratio
Interval 0.19 to 2.03
|
0.75 ratio
Interval 0.22 to 2.39
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Isotype Ratios on Day 56
IgA/IgG3
|
2.73 ratio
Interval 0.38 to 7.75
|
3.03 ratio
Interval 1.55 to 7.44
|
1.44 ratio
Interval 0.02 to 6.97
|
1.68 ratio
Interval 0.29 to 5.13
|
2.4 ratio
Interval 0.89 to 12.5
|
3.02 ratio
Interval 0.41 to 12.3
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 56 after vaccinationPopulation: Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.
Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval.
Outcome measures
| Measure |
A&D - S1
n=5 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=21 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=20 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=11 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
H3N2
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
80.0 percentage of participants
Interval 56.3 to 94.3
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
50.0 percentage of participants
Interval 23.0 to 77.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
B/Phuket
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
55.0 percentage of participants
Interval 31.5 to 76.9
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
28.6 percentage of participants
Interval 8.4 to 58.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
B/Brisbane
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
28.6 percentage of participants
Interval 11.3 to 52.2
|
55.0 percentage of participants
Interval 31.5 to 76.9
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
35.7 percentage of participants
Interval 12.8 to 64.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
H1N1
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
95.0 percentage of participants
Interval 75.1 to 99.9
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
85.7 percentage of participants
Interval 57.2 to 98.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 56 after vaccinationPopulation: Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.
Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of \<1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening.
Outcome measures
| Measure |
A&D - S1
n=2 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=2 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=11 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=11 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=7 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=8 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
n=3 Participants
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
n=2 Participants
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
n=10 Participants
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
n=9 Participants
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
n=4 Participants
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
n=6 Participants
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
H1N1
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
81.8 percentage of participants
Interval 48.2 to 97.7
|
100 percentage of participants
Interval 71.5 to 100.0
|
100 percentage of participants
Interval 59.0 to 100.0
|
87.5 percentage of participants
Interval 47.3 to 99.7
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
60.0 percentage of participants
Interval 26.2 to 87.8
|
88.9 percentage of participants
Interval 51.8 to 99.7
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
B/Phuket
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
50.0 percentage of participants
Interval 6.8 to 93.2
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
B/Brisbane
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
36.4 percentage of participants
Interval 10.9 to 69.2
|
63.6 percentage of participants
Interval 30.8 to 89.1
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
44.4 percentage of participants
Interval 13.7 to 78.8
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
|
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
H3N2
|
0 percentage of participants
Interval 0.0 to 84.2
|
100 percentage of participants
Interval 15.8 to 100.0
|
72.7 percentage of participants
Interval 39.0 to 94.0
|
90.9 percentage of participants
Interval 58.7 to 99.8
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
37.5 percentage of participants
Interval 8.5 to 75.5
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
0 percentage of participants
Interval 0.0 to 84.2
|
70.0 percentage of participants
Interval 34.8 to 93.3
|
66.7 percentage of participants
Interval 29.9 to 92.5
|
75.0 percentage of participants
Interval 19.4 to 99.4
|
66.7 percentage of participants
Interval 22.3 to 95.7
|
SECONDARY outcome
Timeframe: Day 56 after vaccinationPopulation: Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.
Outcome measures
| Measure |
A&D - S1
n=5 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=21 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=20 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=11 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Titers at Day 56 After Vaccination, Overall
B/Phuket
|
5 titers
Interval 5.0 to 80.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 160.0
|
40 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 113.14
|
5 titers
Interval 5.0 to 160.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI Titers at Day 56 After Vaccination, Overall
H1N1
|
5 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 5.0
|
640 titers
Interval 5.0 to 2560.0
|
640 titers
Interval 160.0 to 2560.0
|
905 titers
Interval 40.0 to 5120.0
|
1280 titers
Interval 80.0 to 10240.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI Titers at Day 56 After Vaccination, Overall
H3N2
|
320 titers
Interval 5.0 to 1280.0
|
480 titers
Interval 160.0 to 1280.0
|
1810 titers
Interval 40.0 to 20480.0
|
1093 titers
Interval 5.0 to 5120.0
|
640 titers
Interval 80.0 to 2560.0
|
960 titers
Interval 5.0 to 5120.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
HAI Titers at Day 56 After Vaccination, Overall
B/Brisbane
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 2560.0
|
40 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 452.55
|
42.5 titers
Interval 5.0 to 640.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 56 after vaccinationPopulation: Subjects with complete HAI data at day 56. Subjects without a day 56 sample were not included in analyses.
Outcome measures
| Measure |
A&D - S1
n=2 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=2 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=11 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=11 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=7 Participants
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=8 Participants
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
A&D-S1 Non-VAS
n=3 Participants
Sub-group of subjects from the A\&D-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo-S1 Non-VAS
n=2 Participants
Sub-group of subjects from the Placebo-S1 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D-S2 Non-VAS
n=10 Participants
Sub-group of subjects from the A\&D-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo-S2 Non-VAS
n=9 Participants
Sub-group of subjects from the Placebo-S2 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D-S3 Non-VAS
n=4 Participants
Sub-group of subjects from the A\&D-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo-S3 Non-VAS
n=6 Participants
Sub-group of subjects from the Placebo-S3 group, vitamin A insufficient/deficient (non-VAS), who received influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
H1N1
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 5.0
|
640 titers
Interval 80.0 to 1280.0
|
640 titers
Interval 160.0 to 2560.0
|
1280 titers
Interval 40.0 to 5120.0
|
640 titers
Interval 80.0 to 10240.0
|
5 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 5.0
|
640 titers
Interval 5.0 to 2560.0
|
640 titers
Interval 160.0 to 2560.0
|
640 titers
Interval 640.0 to 3620.4
|
1920 titers
Interval 1280.0 to 2560.0
|
|
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
H3N2
|
200 titers
Interval 80.0 to 320.0
|
720 titers
Interval 160.0 to 1280.0
|
1810 titers
Interval 160.0 to 20480.0
|
1280 titers
Interval 160.0 to 5120.0
|
2560 titers
Interval 160.0 to 2560.0
|
320 titers
Interval 5.0 to 3620.4
|
320 titers
Interval 5.0 to 1280.0
|
480 titers
Interval 320.0 to 640.0
|
1545 titers
Interval 40.0 to 2560.0
|
640 titers
Interval 5.0 to 2560.0
|
400 titers
Interval 80.0 to 1280.0
|
1920 titers
Interval 640.0 to 5120.0
|
|
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
B/Phuket
|
42.5 titers
Interval 5.0 to 80.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 80.0
|
80 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 113.14
|
5 titers
Interval 5.0 to 160.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 160.0
|
5 titers
Interval 5.0 to 80.0
|
42.5 titers
Interval 5.0 to 80.0
|
42.5 titers
Interval 5.0 to 160.0
|
|
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
B/Brisbane
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 640.0
|
40 titers
Interval 5.0 to 320.0
|
80 titers
Interval 5.0 to 452.55
|
80 titers
Interval 5.0 to 640.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 5.0
|
5 titers
Interval 5.0 to 2560.0
|
5 titers
Interval 5.0 to 320.0
|
5 titers
Interval 5.0 to 226.27
|
5 titers
Interval 5.0 to 320.0
|
Adverse Events
A&D-S1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo - S1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
A&D - S2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - S2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
A&D - S3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo - S3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A&D-S1
n=5 participants at risk
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2015-16 season
|
Placebo - S1
n=4 participants at risk
Participants receiving influenza virus vaccine plus matched placebo in 2015-16 season
|
A&D - S2
n=22 participants at risk
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2016-17 season
|
Placebo - S2
n=22 participants at risk
Participants receiving influenza virus vaccine plus matched placebo in 2016-17 season
|
A&D - S3
n=12 participants at risk
Participants receiving influenza virus vaccine plus vitamin A and D supplements in 2017-18 season
|
Placebo - S3
n=14 participants at risk
Participants receiving influenza virus vaccine plus matched placebo in 2017-18 season
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Fever
|
0.00%
0/5 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
9.1%
2/22 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
18.2%
4/22 • Number of events 4 • 56 days after the final participant was dosed on Day 0.
|
8.3%
1/12 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
14.3%
2/14 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
|
Injury, poisoning and procedural complications
Facial trauma/fractured
|
0.00%
0/5 • 56 days after the final participant was dosed on Day 0.
|
25.0%
1/4 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Injury, poisoning and procedural complications
Left forearm bruise
|
0.00%
0/5 • 56 days after the final participant was dosed on Day 0.
|
25.0%
1/4 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • 56 days after the final participant was dosed on Day 0.
|
25.0%
1/4 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
4.5%
1/22 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
4.5%
1/22 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
8.3%
1/12 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
40.0%
2/5 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
13.6%
3/22 • Number of events 3 • 56 days after the final participant was dosed on Day 0.
|
13.6%
3/22 • Number of events 4 • 56 days after the final participant was dosed on Day 0.
|
25.0%
3/12 • Number of events 3 • 56 days after the final participant was dosed on Day 0.
|
14.3%
2/14 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
40.0%
2/5 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
7.1%
1/14 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
|
Infections and infestations
Streptococcal
|
20.0%
1/5 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/22 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
4.5%
1/22 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
4.5%
1/22 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/12 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/14 • 56 days after the final participant was dosed on Day 0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • 56 days after the final participant was dosed on Day 0.
|
0.00%
0/4 • 56 days after the final participant was dosed on Day 0.
|
13.6%
3/22 • Number of events 3 • 56 days after the final participant was dosed on Day 0.
|
9.1%
2/22 • Number of events 2 • 56 days after the final participant was dosed on Day 0.
|
25.0%
3/12 • Number of events 3 • 56 days after the final participant was dosed on Day 0.
|
21.4%
3/14 • Number of events 4 • 56 days after the final participant was dosed on Day 0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place