Trial Outcomes & Findings for Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age (NCT NCT00966238)
NCT ID: NCT00966238
Last Updated: 2014-10-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
within 4 hours following vaccination
Results posted on
2014-10-02
Participant Flow
Participants were recruited across 3 clinical sites.
Participant milestones
| Measure |
0.5 µg i.m.
|
1.0 µg i.m.
|
2.0 µg i.m.
|
3.0 µg i.m.
|
5.0 µg i.m.
|
8.0 µg i.m.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of VAX125 Influenza Vaccine in Community-living Adults >= 65 Years of Age
Baseline characteristics by cohort
| Measure |
0.5 µg i.m.
n=20 Participants
|
1.0 µg i.m.
n=20 Participants
|
2.0 µg i.m.
n=20 Participants
|
3.0 µg i.m.
n=20 Participants
|
5.0 µg i.m.
n=20 Participants
|
8.0 µg i.m.
n=20 Participants
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 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
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
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 6.12 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 4.65 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 4.16 • n=5 Participants
|
71.9 years
STANDARD_DEVIATION 4.28 • n=4 Participants
|
70.7 years
STANDARD_DEVIATION 4.07 • n=21 Participants
|
70.6 years
STANDARD_DEVIATION 4.91 • n=8 Participants
|
71.5 years
STANDARD_DEVIATION 4.71 • n=8 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
53 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: within 4 hours following vaccinationPopulation: Immediate complaints were vaccination symptoms that were solicited and observed at 30 minutes (+15 minutes) and (±30 minutes) after the vaccination on Day 0.
Outcome measures
| Measure |
0.5 µg i.m.
n=20 Participants
|
1.0 µg i.m.
n=20 Participants
|
2.0 µg i.m.
n=20 Participants
|
3.0 µg i.m.
n=20 Participants
|
5.0 µg i.m.
n=20 Participants
|
8.0 µg i.m.
n=20 Participants
|
|---|---|---|---|---|---|---|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Bruising
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Arm Pain
|
8 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
11 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Fatigue
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Joint Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Muscle Aches
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Chills
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Immediate Reactogenicity Complaints
Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 days after vaccinationPopulation: The immunogenicity of the vaccine was evaluated by measuring the number of subjects who demonstrate seroconversion either by developing a measurable titer following vaccination or by showing a significant increase in HAI serum antibody titers post-vaccination.
Outcome measures
| Measure |
0.5 µg i.m.
n=20 Participants
|
1.0 µg i.m.
n=20 Participants
|
2.0 µg i.m.
n=20 Participants
|
3.0 µg i.m.
n=20 Participants
|
5.0 µg i.m.
n=20 Participants
|
8.0 µg i.m.
n=20 Participants
|
|---|---|---|---|---|---|---|
|
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Baseline
|
27.32 Titers
Interval 14.34 to 52.04
|
27.32 Titers
Interval 15.0 to 49.77
|
24.62 Titers
Interval 11.87 to 51.09
|
50.98 Titers
Interval 29.13 to 89.22
|
18.59 Titers
Interval 10.01 to 34.53
|
30.31 Titers
Interval 15.93 to 57.7
|
|
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Day 7
|
30.31 Titers
Interval 15.79 to 58.2
|
38.64 Titers
Interval 21.21 to 70.39
|
50.98 Titers
Interval 24.72 to 105.12
|
105.56 Titers
Interval 49.64 to 224.5
|
66.66 Titers
Interval 37.85 to 117.42
|
154.55 Titers
Interval 85.63 to 278.94
|
|
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Day 14
|
42.87 Titers
Interval 22.05 to 83.35
|
77.27 Titers
Interval 43.22 to 138.16
|
69.64 Titers
Interval 33.95 to 142.86
|
160.00 Titers
Interval 82.23 to 311.32
|
230.44 Titers
Interval 119.96 to 442.68
|
234.25 Titers
Interval 127.42 to 430.68
|
|
Geometric Mean Hemagglutinin Inhibition (HAI) Antibody Titers
Day 28
|
47.57 Titers
Interval 23.88 to 94.76
|
74.64 Titers
Interval 44.15 to 126.21
|
69.64 Titers
Interval 33.95 to 142.86
|
149.29 Titers
Interval 78.77 to 282.93
|
222.18 Titers
Interval 113.51 to 434.89
|
211.12 Titers
Interval 120.49 to 369.94
|
Adverse Events
0.5 µg i.m.
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
1.0 µg i.m.
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
2.0 µg i.m.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3.0 µg i.m.
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
5.0 µg i.m.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8.0 µg i.m.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.5 µg i.m.
n=20 participants at risk
|
1.0 µg i.m.
n=20 participants at risk
|
2.0 µg i.m.
n=20 participants at risk
|
3.0 µg i.m.
n=20 participants at risk
|
5.0 µg i.m.
n=20 participants at risk
|
8.0 µg i.m.
n=20 participants at risk
|
|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast Cancer
|
5.0%
1/20 • Number of events 1 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Non-small cell lung cancer
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
5.0%
1/20 • Number of events 1 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
5.0%
1/20 • Number of events 1 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
Other adverse events
| Measure |
0.5 µg i.m.
n=20 participants at risk
|
1.0 µg i.m.
n=20 participants at risk
|
2.0 µg i.m.
n=20 participants at risk
|
3.0 µg i.m.
n=20 participants at risk
|
5.0 µg i.m.
n=20 participants at risk
|
8.0 µg i.m.
n=20 participants at risk
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
10.0%
2/20 • Number of events 2 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
0.00%
0/20 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 28 days following vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60