Trial Outcomes & Findings for A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) (NCT NCT00877448)
NCT ID: NCT00877448
Last Updated: 2023-03-07
Results Overview
Number of adverse events per cohort
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
63 participants
Primary outcome timeframe
day 0 until day 42 (termination visit)
Results posted on
2023-03-07
Participant Flow
Recruitment was done on a running basis after eligibility of inclusion/exclusion criteria was met and subjects were invited to clinic after screening procedures within up to 21 days before their first vaccination.
After meeting eligibility criteria to enter the study subjects were randomized simultaneously.
Participant milestones
| Measure |
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
|
Adjuvanted Multimeric -001 250 mcg
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
|
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
|
Adjuvanted PBS
Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
|
Multimeric-001 in PBS 500 mcg
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
|
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
|
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
3
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
9
|
10
|
9
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Baseline characteristics by cohort
| Measure |
Multimeric-001 250 mcg in PBS
n=10 Participants
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
|
Adjuvanted Multimeric -001 250 mcg
n=10 Participants
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
|
PBS (Placebo)
n=10 Participants
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
|
Adjuvanted PBS
n=10 Participants
Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
|
Multimeric-001 in PBS 500 mcg
n=10 Participants
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
|
Adjuvanted Multimeric-001 500 mcg
n=10 Participants
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
|
Multimeric-001 125 mcg
n=3 Participants
Multimeric-001 125 mcg in PBS administered once only.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
63 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 4.0 • n=99 Participants
|
25.8 years
STANDARD_DEVIATION 8.8 • n=107 Participants
|
25.2 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
26.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
29.0 years
STANDARD_DEVIATION 7.4 • n=31 Participants
|
25.2 years
STANDARD_DEVIATION 4.5 • n=30 Participants
|
25.7 years
STANDARD_DEVIATION 3.3 • n=3 Participants
|
25.9 years
STANDARD_DEVIATION 6.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
54 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Region of Enrollment
Israel
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
10 participants
n=7 Participants
|
10 participants
n=31 Participants
|
10 participants
n=30 Participants
|
3 participants
n=3 Participants
|
63 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: day 0 until day 42 (termination visit)Number of adverse events per cohort
Outcome measures
| Measure |
Multimeric-001 250 mcg in PBS
n=10 Participants
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
|
Adjuvanted Multimeric -001 250 mcg
n=10 Participants
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
|
PBS (Placebo)
n=10 Participants
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
|
Adjuvanted PBS
n=10 Participants
Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
|
Multimeric-001 in PBS 500 mcg
n=10 Participants
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
|
Adjuvanted Multimeric-001 500 mcg
n=10 Participants
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
|
Multimeric-001 125 mcg
n=3 Participants
Multimeric-001 125 mcg in PBS administered once only.
|
|---|---|---|---|---|---|---|---|
|
Adverse Events
|
46 number of reported events
|
28 number of reported events
|
29 number of reported events
|
36 number of reported events
|
42 number of reported events
|
20 number of reported events
|
2 number of reported events
|
PRIMARY outcome
Timeframe: Day 0 until day 42 (termination visit)Number of treatment-related adverse events per cohort
Outcome measures
| Measure |
Multimeric-001 250 mcg in PBS
n=10 Participants
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
|
Adjuvanted Multimeric -001 250 mcg
n=10 Participants
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
|
PBS (Placebo)
n=10 Participants
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
|
Adjuvanted PBS
n=10 Participants
Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
|
Multimeric-001 in PBS 500 mcg
n=10 Participants
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
|
Adjuvanted Multimeric-001 500 mcg
n=10 Participants
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
|
Multimeric-001 125 mcg
n=3 Participants
Multimeric-001 125 mcg in PBS administered once only.
|
|---|---|---|---|---|---|---|---|
|
Treatment-related Adverse Events
|
8 number of reported events
|
11 number of reported events
|
3 number of reported events
|
17 number of reported events
|
3 number of reported events
|
9 number of reported events
|
0 number of reported events
|
Adverse Events
Multimeric-001 250 mcg in PBS
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Adjuvanted Multimeric -001 250 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PBS (Placebo)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Adjuvanted PBS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Multimeric-001 in PBS 500 mcg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Adjuvanted Multimeric-001 500 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Multimeric-001 125 mcg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multimeric-001 250 mcg in PBS
n=10 participants at risk
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
|
Adjuvanted Multimeric -001 250 mcg
n=10 participants at risk
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
|
PBS (Placebo)
n=10 participants at risk
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
|
Adjuvanted PBS
n=10 participants at risk
Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
|
Multimeric-001 in PBS 500 mcg
n=10 participants at risk
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
|
Adjuvanted Multimeric-001 500 mcg
n=10 participants at risk
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
|
Multimeric-001 125 mcg
n=3 participants at risk
Multimeric-001 125 mcg in PBS administered once only.
|
|---|---|---|---|---|---|---|---|
|
General disorders
General disorders
|
60.0%
6/10 • Number of events 11 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 7 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
50.0%
5/10 • Number of events 13 • day 0 until day 42 (termination visit)
|
40.0%
4/10 • Number of events 9 • day 0 until day 42 (termination visit)
|
60.0%
6/10 • Number of events 12 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
30.0%
3/10 • Number of events 7 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 10 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 10 • day 0 until day 42 (termination visit)
|
50.0%
5/10 • Number of events 11 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 6 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Infections and infestations
Infections and infestations
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
33.3%
1/3 • Number of events 1 • day 0 until day 42 (termination visit)
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Investigations
Investigations
|
40.0%
4/10 • Number of events 6 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 5 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
33.3%
1/3 • Number of events 1 • day 0 until day 42 (termination visit)
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition disorders
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Musculoskeletal and connective tissue disorders
Musculosceletal and connective tissue disorders
|
50.0%
5/10 • Number of events 6 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
0.00%
0/10 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 5 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
40.0%
4/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Nervous system disorders
Nervous system disorders
|
50.0%
5/10 • Number of events 6 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 5 • day 0 until day 42 (termination visit)
|
60.0%
6/10 • Number of events 9 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Renal and urinary disorders
Renal and Urinary disorders
|
30.0%
3/10 • Number of events 5 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
30.0%
3/10 • Number of events 5 • day 0 until day 42 (termination visit)
|
20.0%
2/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 4 • day 0 until day 42 (termination visit)
|
40.0%
4/10 • Number of events 8 • day 0 until day 42 (termination visit)
|
60.0%
6/10 • Number of events 6 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous tissue disorders
|
10.0%
1/10 • Number of events 2 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
10.0%
1/10 • Number of events 1 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
30.0%
3/10 • Number of events 3 • day 0 until day 42 (termination visit)
|
0.00%
0/3 • day 0 until day 42 (termination visit)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60