Trial Outcomes & Findings for Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults (NCT NCT00868218)
NCT ID: NCT00868218
Last Updated: 2019-11-18
Results Overview
The primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
three months
Results posted on
2019-11-18
Participant Flow
Haukeland University hospital recrutiment in 2009
Haelthy person were randomly assigned to one of 4 vaccine groups
Participant milestones
| Measure |
30µg HA Vaccine
30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Parenterally Administered H5N1 Influenza Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
30µg HA Vaccine
n=15 Participants
30µg HA vaccine Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
n=15 Participants
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
n=15 Participants
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
n=15 Participants
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
Total
n=60 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
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
60 Participants
n=21 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
|
|
Age, Continuous
|
32 years
n=5 Participants
|
29 years
n=7 Participants
|
31 years
n=5 Participants
|
31 years
n=4 Participants
|
31 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Region of Enrollment
Norway
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
15 participants
n=4 Participants
|
60 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: three monthsThe primary endpoints of the trial are the local and systemic adverse events and tolerability of parenterally administered virosomal H5N1 influenza vaccine with or without 3rd generation ISCOM™ adjuvant.
Outcome measures
| Measure |
30µg HA Vaccine
n=15 Participants
30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
n=15 Participants
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
n=15 Participants
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
n=15 Participants
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
|---|---|---|---|---|
|
Solicted Adverse Events
|
8 participants
|
12 participants
|
13 participants
|
14 participants
|
PRIMARY outcome
Timeframe: 42 daysOutcome measures
| Measure |
30µg HA Vaccine
n=15 Participants
30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
n=15 Participants
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
n=15 Participants
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
n=15 Participants
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
|---|---|---|---|---|
|
Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: one yearNumber of participants with haemagglutination inhibition tigers \>= 32 at the long term time point (1 year post vaccination).
Outcome measures
| Measure |
30µg HA Vaccine
n=15 Participants
30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
n=15 Participants
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
n=15 Participants
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
n=15 Participants
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
|---|---|---|---|---|
|
Immunogenicity of a Non-adjuvanted and 3rd Generation ISCOM™ Adjuvanted Virosomal H5N1 Influenza Vaccine
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
Adverse Events
30µg HA Vaccine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
1.5µg HA Adjuvanted
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
7.5µg HA Adjuvanted
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
30µg HA Adjuvanted
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
30µg HA Vaccine
n=15 participants at risk
30µg HA vaccine Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
1.5µg HA Adjuvanted
n=15 participants at risk
1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
7.5µg HA Adjuvanted
n=15 participants at risk
7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
30µg HA Adjuvanted
n=15 participants at risk
30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
Influenza vaccine: Influenza virus strain:
avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
|
|---|---|---|---|---|
|
Infections and infestations
local or systemic reactions
|
53.3%
8/15 • Number of events 8 • AE were solicited for 42 days after vaccination
Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
|
86.7%
13/15 • Number of events 13 • AE were solicited for 42 days after vaccination
Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
|
80.0%
12/15 • Number of events 12 • AE were solicited for 42 days after vaccination
Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
|
86.7%
13/15 • Number of events 13 • AE were solicited for 42 days after vaccination
Each participant received an AE form which was returned to the clinic 21 days after each vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place