Trial Outcomes & Findings for Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults (NCT NCT00921947)
NCT ID: NCT00921947
Last Updated: 2011-08-24
Results Overview
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
60 participants
Primary outcome timeframe
0 to 7 days after vaccination
Results posted on
2011-08-24
Participant Flow
Participant milestones
| Measure |
VAX102 IM
Given as 1 µg intramuscular
|
VAX102 SC
Given as 2 µg subcutaneous
|
|---|---|---|
|
Day 0
STARTED
|
30
|
30
|
|
Day 0
COMPLETED
|
30
|
30
|
|
Day 0
NOT COMPLETED
|
0
|
0
|
|
Day 28
STARTED
|
28
|
30
|
|
Day 28
COMPLETED
|
28
|
30
|
|
Day 28
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults
Baseline characteristics by cohort
| Measure |
VAX102 IM
n=30 Participants
Given as 1 µg intramuscular
|
VAX102 SC
n=30 Participants
Given as 2 µg subcutaneous
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
27.3 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
26.7 years
STANDARD_DEVIATION 8.74 • n=7 Participants
|
27 years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 7 days after vaccinationPopulation: The population analyzed included all participants receiving at least 1 dose of the vaccine.
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Outcome measures
| Measure |
VAX102 1.0 µg i.m.
n=30 Participants
|
VAX102 2.0 µg s.c.
n=30 Participants
|
|---|---|---|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Redness
|
0 participants
|
13 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Swelling
|
2 participants
|
3 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Bruising
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Arm Pain
|
23 participants
|
21 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Headache
|
5 participants
|
3 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Fatigue
|
4 participants
|
4 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Joint Pain
|
4 participants
|
3 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Muscle Aches
|
13 participants
|
10 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Chills
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Sweating
|
1 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 14 days after vaccinationSolicited local and general symptoms experienced within 14 days after vaccination 2
Outcome measures
| Measure |
VAX102 1.0 µg i.m.
n=28 Participants
|
VAX102 2.0 µg s.c.
n=30 Participants
|
|---|---|---|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Redness
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Swelling
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Bruising
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Arm pain
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Headache
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Fatigue
|
0 participants
|
1 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Joint Pain
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Muscle Aches
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Chills
|
0 participants
|
0 participants
|
|
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Sweating
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 42 days (+/- 2)Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
Outcome measures
| Measure |
VAX102 1.0 µg i.m.
n=28 Participants
|
VAX102 2.0 µg s.c.
n=30 Participants
|
|---|---|---|
|
Anti-M2e Serum Antibody Concentration
Baseline
|
0.011 Titers
Interval 0.007 to 0.018
|
0.012 Titers
Interval 0.008 to 0.019
|
|
Anti-M2e Serum Antibody Concentration
Day 14
|
0.376 Titers
Interval 0.206 to 0.685
|
0.375 Titers
Interval 0.241 to 0.585
|
|
Anti-M2e Serum Antibody Concentration
Day 28
|
0.255 Titers
Interval 0.148 to 0.437
|
0.248 Titers
Interval 0.165 to 0.374
|
|
Anti-M2e Serum Antibody Concentration
Day 42
|
1.121 Titers
Interval 0.744 to 1.689
|
2.062 Titers
Interval 1.385 to 3.071
|
Adverse Events
VAX102 IM
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
VAX102 SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VAX102 IM
n=28 participants at risk
Given as 1 µg intramuscular
|
VAX102 SC
n=30 participants at risk
Given as 2 µg subcutaneous
|
|---|---|---|
|
Renal and urinary disorders
Hydronephrosis
|
3.6%
1/28 • Number of events 1 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 42 days following vaccination.
All reactogenicity findings were recorded in the CRFs. Symptoms from the Reactogenicity Memory Aid were reported as "reactogenicity", and presumed to be related to the investigational product. These complaints were not additionally recorded as AEs.
|
0.00%
0/30 • Serious adverse events were collected for 1 year following vaccination. All adverse events were collected for 42 days following vaccination.
All reactogenicity findings were recorded in the CRFs. Symptoms from the Reactogenicity Memory Aid were reported as "reactogenicity", and presumed to be related to the investigational product. These complaints were not additionally recorded as AEs.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60