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Intradermal Influenza Vaccine Study in Elders

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ClinicalTrials.gov Identifier: NCT00504231
Recruitment Status : Completed
First Posted : July 19, 2007
Results First Posted : July 13, 2012
Last Update Posted : July 13, 2012
Sponsor:
Collaborators:
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Information provided by (Responsible Party):
PATH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Intervention Biological: Fluzone Influenza Vaccine (2007-2008)
Enrollment 257
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Hide Arm/Group Description 0.5 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intradermally 0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
Period Title: Overall Study
Started 65 64 64 65
Completed 65 64 63 65
Not Completed 0 0 1 0
Reason Not Completed
Discrepant chart documentation re route             0             0             1             0
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID Total
Hide Arm/Group Description 0.5 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intradermally 0.15 mL influenza vaccine twice delivered intradermally with needle and syringe Total of all reporting groups
Overall Number of Baseline Participants 65 64 63 65 257
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 63 participants 65 participants 257 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
65
 100.0%
64
 100.0%
63
 100.0%
65
 100.0%
257
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 64 participants 63 participants 65 participants 257 participants
75.6  (6.8) 75.2  (7.7) 73.6  (6.3) 74.7  (6.3) 74.8  (6.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 63 participants 65 participants 257 participants
Female
11
  16.9%
11
  17.2%
11
  17.5%
11
  16.9%
44
  17.1%
Male
54
  83.1%
53
  82.8%
52
  82.5%
54
  83.1%
213
  82.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 63 participants 65 participants 257 participants
Hispanic or Latino
0
   0.0%
1
   1.6%
1
   1.6%
1
   1.5%
3
   1.2%
Not Hispanic or Latino
65
 100.0%
63
  98.4%
62
  98.4%
64
  98.5%
254
  98.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 64 participants 63 participants 65 participants 257 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   3.1%
0
   0.0%
2
   3.2%
2
   3.1%
6
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   6.2%
2
   3.1%
3
   4.8%
5
   7.7%
14
   5.4%
White
56
  86.2%
60
  93.8%
55
  87.3%
53
  81.5%
224
  87.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.6%
2
   3.1%
3
   4.8%
5
   7.7%
13
   5.1%
1.Primary Outcome
Title Seroprotection Pre- and Post- Vaccination
Hide Description 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)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Hide Arm/Group Description:
100% dose - 0.5mL delivered intramuscularly with needle and syringe
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
60% dose - 0.3 mL delivered intradermally with needle and syringe
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
Overall Number of Participants Analyzed 64 64 63 65
Measure Type: Number
Unit of Measure: % of Participants
A/H1N1 Seroprotection Prevaccination 18.5 12.5 19.1 15.4
A/H1N1 Seroprotection 4 weeks after vaccination 65.6 57.8 68.9 67.2
A/H3N2 Seroprotection Prevaccination 47.7 46.9 49.2 47.7
A/H3N2 Seroprotection 4 weeks after vaccination 76.6 75.0 75.4 75.0
B Seroprotection Prevaccination 15.4 12.5 14.3 20.0
B Seroprotection 4 weeks after vaccination 26.6 17.2 16.5 25.0
2.Secondary Outcome
Title Geometric Mean Titer (GMT) Pre- and Post- Vaccination
Hide Description GMT 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)
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Hide Arm/Group Description:
100% dose - 0.5mL delivered intramuscularly with needle and syringe
60% dose - 0.3 mL delivered intramuscularly with needle and syringe
60% dose - 0.3 mL delivered intradermally with needle and syringe
60% dose - 0.15 mL delivered twice intradermally with needle and syringe
Overall Number of Participants Analyzed 64 64 63 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: GMT
A/H1N1 Prevaccination
12.5
(9.8 to 16.0)
11.3
(8.9 to 14.3)
13.6
(10.7 to 17.4)
11.2
(9.1 to 13.9)
A/H1N1 4 weeks after vaccination
54.2
(40.0 to 73.4)
41.8
(29.5 to 59.2)
48.0
(34.6 to 66.5)
48.6
(36.2 to 65.2)
A/H3N2 Prevaccination
33.7
(23.9 to 47.6)
27.1
(20.1 to 36.4)
29.4
(21.1 to 40.8)
29.0
(21.2 to 39.7)
A/H3N2 4 weeks after vaccination
79.1
(57.6 to 108.6)
62.4
(46.6 to 83.5)
57.5
(42.4 to 78.1)
72.6
(53.2 to 99.1)
B Prevaccination
10.7
(8.6 to 13.2)
10.1
(8.2 to 12.5)
9.8
(7.8 to 12.3)
12.8
(9.9 to 16.5)
B 4 weeks after vaccination
16.5
(12.7 to 21.4)
12.4
(10.0 to 15.5)
10.8
(8.5 to 13.8)
15.9
(12.1 to 20.9)
3.Secondary Outcome
Title Assessment of Reactogenicity
Hide Description Maximum solicited systemic and local signs and symptoms during the week after initial vaccination, by Dose and Randomization Assignment
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Hide Arm/Group Description:
0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
0.3 mL influenza vaccine delivered intradermally
0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
Overall Number of Participants Analyzed 64 64 63 65
Measure Type: Number
Unit of Measure: participants
Fever, >=38.0C and <39.0C 0 1 0 3
Fever, >=39 0 0 0 1
Chills, present but easily tolerated 1 1 1 6
Chills, interferes with normal activities 1 1 0 1
Fatigue, present but easily tolerated 4 6 3 8
Fatigue, interferes with normal activity 2 1 0 6
General body ache/pain, present but easily tolerat 6 5 3 11
General body ache/pain, interferes with normal a 1 2 2 4
Headache, present but easily tolerated 10 5 4 9
Headache, interferes with normal activity 0 1 0 5
Nausea, present but easily tolerated 3 2 2 3
Nausea, interferes with normal activity 1 1 0 0
Redness or Discoloration, <=8 cm 9 7 45 52
Redness or Discoloration, >8 cm 0 0 3 4
Localized swelling, <=8 cm 13 4 37 44
Localized swelling, >8 cm 0 0 3 4
Pain at injection site, present but easily tolerat 7 11 7 14
Pain at injection site, interferes with normal act 0 0 0 0
Itching at injection site, present but tolerated 4 5 15 19
Itching at injection site, interferes with normal 0 0 0 2
Arm motion limitation, some limitiation 1 1 0 0
Arm motion limitation, interferes normal activity 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Hide Arm/Group Description 0.5 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intramuscularly with needle/syringe 0.3 mL influenza vaccine delivered intradermally 0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
All-Cause Mortality
Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      2/64 (3.13%)      1/64 (1.56%)      3/65 (4.62%)    
Cardiac disorders         
Acute coronary syndrome  [1]  0/65 (0.00%)  0 1/64 (1.56%)  1 0/64 (0.00%)  0 0/65 (0.00%)  0
anemia and arrhythmia  [2]  0/65 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/65 (0.00%)  0
Gastrointestinal disorders         
Appendicitis  [1]  0/65 (0.00%)  0 1/64 (1.56%)  1 0/64 (0.00%)  0 0/65 (0.00%)  0
small bowel obstruction   0/65 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/65 (1.54%)  1
nausea and vomiting  [2]  0/65 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/65 (1.54%)  1
Injury, poisoning and procedural complications         
complicated fall *  0/65 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/65 (1.54%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Resulted in hospitalization.
[2]
Resulted in hospitalization
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Full-dose 0.5 mL IM 60% Dose 0.3 mL IM 60% Dose 0.3 mL ID 60% Dose 0.15 mL x 2 ID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/65 (0.00%)      0/64 (0.00%)      0/64 (0.00%)      0/65 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ru-Chien Chi B.S., M.D., M.S.
Organization: University of Washington
Phone: 206 768-5217
EMail: rchi@u.washington.edu
Layout table for additonal information
Responsible Party: PATH
ClinicalTrials.gov Identifier: NCT00504231    
Other Study ID Numbers: ID/RD01
First Submitted: July 12, 2007
First Posted: July 19, 2007
Results First Submitted: January 11, 2012
Results First Posted: July 13, 2012
Last Update Posted: July 13, 2012