Trial Outcomes & Findings for Intradermal Influenza Vaccine Study in Elders (NCT NCT00504231)
NCT ID: NCT00504231
Last Updated: 2012-07-13
Results Overview
Seroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
1 month
Results posted on
2012-07-13
Participant Flow
Participant milestones
| Measure |
Full-dose 0.5 mL IM
0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL IM
0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL ID
0.3 mL influenza vaccine delivered intradermally
|
60% Dose 0.15 mL x 2 ID
0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
64
|
65
|
|
Overall Study
COMPLETED
|
65
|
64
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Full-dose 0.5 mL IM
0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL IM
0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL ID
0.3 mL influenza vaccine delivered intradermally
|
60% Dose 0.15 mL x 2 ID
0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
|
|---|---|---|---|---|
|
Overall Study
Discrepant chart documentation re route
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Intradermal Influenza Vaccine Study in Elders
Baseline characteristics by cohort
| Measure |
Full-dose 0.5 mL IM
n=65 Participants
0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL IM
n=64 Participants
0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL ID
n=63 Participants
0.3 mL influenza vaccine delivered intradermally
|
60% Dose 0.15 mL x 2 ID
n=65 Participants
0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
|
Total
n=257 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
|
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
>=65 years
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
257 Participants
n=21 Participants
|
|
Age Continuous
|
75.6 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
75.2 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
73.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
74.7 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
74.8 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
213 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
254 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
224 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 monthSeroprotection before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) Intramuscular (IM) or Reduced-Dose (9 mg) Intradermal (ID) Injections for A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)
Outcome measures
| Measure |
Full-dose 0.5 mL IM
n=64 Participants
100% dose - 0.5mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL IM
n=64 Participants
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL ID
n=63 Participants
60% dose - 0.3 mL delivered intradermally with needle and syringe
|
60% Dose 0.15 mL x 2 ID
n=65 Participants
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
|
|---|---|---|---|---|
|
Seroprotection Pre- and Post- Vaccination
A/H1N1 Seroprotection Prevaccination
|
18.5 % of Participants
Interval 34.6 to 66.5
|
12.5 % of Participants
Interval 40.0 to 73.4
|
19.1 % of Participants
|
15.4 % of Participants
|
|
Seroprotection Pre- and Post- Vaccination
A/H1N1 Seroprotection 4 weeks after vaccination
|
65.6 % of Participants
|
57.8 % of Participants
|
68.9 % of Participants
|
67.2 % of Participants
|
|
Seroprotection Pre- and Post- Vaccination
A/H3N2 Seroprotection Prevaccination
|
47.7 % of Participants
|
46.9 % of Participants
|
49.2 % of Participants
|
47.7 % of Participants
|
|
Seroprotection Pre- and Post- Vaccination
A/H3N2 Seroprotection 4 weeks after vaccination
|
76.6 % of Participants
|
75.0 % of Participants
|
75.4 % of Participants
|
75.0 % of Participants
|
|
Seroprotection Pre- and Post- Vaccination
B Seroprotection Prevaccination
|
15.4 % of Participants
|
12.5 % of Participants
|
14.3 % of Participants
|
20.0 % of Participants
|
|
Seroprotection Pre- and Post- Vaccination
B Seroprotection 4 weeks after vaccination
|
26.6 % of Participants
|
17.2 % of Participants
|
16.5 % of Participants
|
25.0 % of Participants
|
SECONDARY outcome
Timeframe: 1 monthGMT before and 4 Weeks after Vaccination by Full- or Reduced-Dose (9 mg) IM or Reduced-Dose (9 mg) ID Injections. A/Solomon Islands/3/2006 (A/H1N1), A/Wisconsin/67/2005 (A/H3N2), B/Malaysia/2506/2004 (B)
Outcome measures
| Measure |
Full-dose 0.5 mL IM
n=64 Participants
100% dose - 0.5mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL IM
n=64 Participants
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL ID
n=63 Participants
60% dose - 0.3 mL delivered intradermally with needle and syringe
|
60% Dose 0.15 mL x 2 ID
n=65 Participants
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
A/H1N1 Prevaccination
|
12.5 GMT
Interval 9.8 to 16.0
|
11.3 GMT
Interval 8.9 to 14.3
|
13.6 GMT
Interval 10.7 to 17.4
|
11.2 GMT
Interval 9.1 to 13.9
|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
A/H1N1 4 weeks after vaccination
|
54.2 GMT
Interval 40.0 to 73.4
|
41.8 GMT
Interval 29.5 to 59.2
|
48.0 GMT
Interval 34.6 to 66.5
|
48.6 GMT
Interval 36.2 to 65.2
|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
A/H3N2 Prevaccination
|
33.7 GMT
Interval 23.9 to 47.6
|
27.1 GMT
Interval 20.1 to 36.4
|
29.4 GMT
Interval 21.1 to 40.8
|
29.0 GMT
Interval 21.2 to 39.7
|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
A/H3N2 4 weeks after vaccination
|
79.1 GMT
Interval 57.6 to 108.6
|
62.4 GMT
Interval 46.6 to 83.5
|
57.5 GMT
Interval 42.4 to 78.1
|
72.6 GMT
Interval 53.2 to 99.1
|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
B Prevaccination
|
10.7 GMT
Interval 8.6 to 13.2
|
10.1 GMT
Interval 8.2 to 12.5
|
9.8 GMT
Interval 7.8 to 12.3
|
12.8 GMT
Interval 9.9 to 16.5
|
|
Geometric Mean Titer (GMT) Pre- and Post- Vaccination
B 4 weeks after vaccination
|
16.5 GMT
Interval 12.7 to 21.4
|
12.4 GMT
Interval 10.0 to 15.5
|
10.8 GMT
Interval 8.5 to 13.8
|
15.9 GMT
Interval 12.1 to 20.9
|
SECONDARY outcome
Timeframe: 1 weekMaximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment
Outcome measures
| Measure |
Full-dose 0.5 mL IM
n=64 Participants
100% dose - 0.5mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL IM
n=64 Participants
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
|
60% Dose 0.3 mL ID
n=63 Participants
60% dose - 0.3 mL delivered intradermally with needle and syringe
|
60% Dose 0.15 mL x 2 ID
n=65 Participants
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
|
|---|---|---|---|---|
|
Assessment of Reactogenicity
Fever, >=38.0C and <39.0C
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Assessment of Reactogenicity
Fever, >=39
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Assessment of Reactogenicity
Chills, present but easily tolerated
|
1 participants
|
1 participants
|
1 participants
|
6 participants
|
|
Assessment of Reactogenicity
Chills, interferes with normal activities
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Assessment of Reactogenicity
Fatigue, present but easily tolerated
|
4 participants
|
6 participants
|
3 participants
|
8 participants
|
|
Assessment of Reactogenicity
Fatigue, interferes with normal activity
|
2 participants
|
1 participants
|
0 participants
|
6 participants
|
|
Assessment of Reactogenicity
General body ache/pain, present but easily tolerat
|
6 participants
|
5 participants
|
3 participants
|
11 participants
|
|
Assessment of Reactogenicity
General body ache/pain, interferes with normal a
|
1 participants
|
2 participants
|
2 participants
|
4 participants
|
|
Assessment of Reactogenicity
Headache, present but easily tolerated
|
10 participants
|
5 participants
|
4 participants
|
9 participants
|
|
Assessment of Reactogenicity
Headache, interferes with normal activity
|
0 participants
|
1 participants
|
0 participants
|
5 participants
|
|
Assessment of Reactogenicity
Nausea, present but easily tolerated
|
3 participants
|
2 participants
|
2 participants
|
3 participants
|
|
Assessment of Reactogenicity
Nausea, interferes with normal activity
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Assessment of Reactogenicity
Redness or Discoloration, <=8 cm
|
9 participants
|
7 participants
|
45 participants
|
52 participants
|
|
Assessment of Reactogenicity
Redness or Discoloration, >8 cm
|
0 participants
|
0 participants
|
3 participants
|
4 participants
|
|
Assessment of Reactogenicity
Localized swelling, <=8 cm
|
13 participants
|
4 participants
|
37 participants
|
44 participants
|
|
Assessment of Reactogenicity
Localized swelling, >8 cm
|
0 participants
|
0 participants
|
3 participants
|
4 participants
|
|
Assessment of Reactogenicity
Pain at injection site, present but easily tolerat
|
7 participants
|
11 participants
|
7 participants
|
14 participants
|
|
Assessment of Reactogenicity
Pain at injection site, interferes with normal act
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Assessment of Reactogenicity
Itching at injection site, present but tolerated
|
4 participants
|
5 participants
|
15 participants
|
19 participants
|
|
Assessment of Reactogenicity
Itching at injection site, interferes with normal
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Assessment of Reactogenicity
Arm motion limitation, some limitiation
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Assessment of Reactogenicity
Arm motion limitation, interferes normal activity
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Full-dose 0.5 mL IM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
60% Dose 0.3 mL IM
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
60% Dose 0.3 mL ID
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
60% Dose 0.15 mL x 2 ID
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Full-dose 0.5 mL IM
n=65 participants at risk
0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL IM
n=64 participants at risk
0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
|
60% Dose 0.3 mL ID
n=64 participants at risk
0.3 mL influenza vaccine delivered intradermally
|
60% Dose 0.15 mL x 2 ID
n=65 participants at risk
0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
|
|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/65
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/65
|
1.6%
1/64 • Number of events 1
|
0.00%
0/64
|
0.00%
0/65
|
|
Cardiac disorders
anemia and arrhythmia
|
0.00%
0/65
|
0.00%
0/64
|
1.6%
1/64 • Number of events 1
|
0.00%
0/65
|
|
Gastrointestinal disorders
small bowel obstruction
|
0.00%
0/65
|
0.00%
0/64
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Injury, poisoning and procedural complications
complicated fall
|
0.00%
0/65
|
0.00%
0/64
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
|
Gastrointestinal disorders
nausea and vomiting
|
0.00%
0/65
|
0.00%
0/64
|
0.00%
0/64
|
1.5%
1/65 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place