Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00775450
Collaborator
(none)
807
28
5
9
28.8
3.2
Study Details
Study Description
Brief Summary
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
Study Design
Study Type:
Interventional
Actual Enrollment
:
807 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Jun 1, 2009
Actual Study Completion Date
:
Jul 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1a: Fluzone ID After Fluzone ID
|
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Other Names:
|
| Experimental: Group 1b: Fluzone IM After Fluzone ID
|
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Names:
|
| Active Comparator: Group 2a: Fluzone IM After Fluzone IM
|
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Names:
|
| Experimental: Group 2b: Fluzone ID After Fluzone IM
|
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Other Names:
|
| Active Comparator: Group 3: Fluzone HD After Fluzone HD
|
Biological: Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [Days 0 through 7 post vaccination]
Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering.
Secondary Outcome Measures
- Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection [Day 0 and Day 28 post-vaccination]
Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay.
- Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [Days 0 and 28 post-vaccination]
Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28.
- Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine [Day 28 post vaccination]
Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination.
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Aged ≥ 65 years on the day of vaccination
-
Enrolled in and completed study FID29 and received the correct vaccine for the group to which they were randomized
-
Informed consent form signed and dated
-
Able to attend all scheduled visits and to comply with all trial procedures
-
Subject is medically stable.
Exclusion Criteria :
-
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination
-
Planned participation in another clinical trial during the present trial period
-
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
-
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
-
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
-
Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
-
Receipt of any vaccination in the 4 weeks preceding the trial vaccination
-
Planned receipt of any vaccine in the 4 weeks following the trial vaccination
-
Known human immunodeficiency virus (HIV), hepatitis B (HBs) antigen, or Hepatitis C seropositivity.
-
Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine
-
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
-
Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
-
Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, as well as subjects who have a history of neoplastic disease and who have been disease free for ≥ 5 years).
-
Personal or family history of Guillain-Barré Syndrome.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hoover | Alabama | United States | 35216 | |
| 2 | Mobile | Alabama | United States | 36608 | |
| 3 | Chandler | Arizona | United States | 85224 | |
| 4 | Mesa | Arizona | United States | 85213 | |
| 5 | Phoenix | Arizona | United States | 85014 | |
| 6 | Tucson | Arizona | United States | 85710 | |
| 7 | Fountain Valley | California | United States | 92708 | |
| 8 | San Diego | California | United States | 92103 | |
| 9 | Milford | Connecticut | United States | 06460 | |
| 10 | Pembroke Pines | Florida | United States | 33024 | |
| 11 | Pinellas Park | Florida | United States | 33781 | |
| 12 | Chicago | Illinois | United States | 60610 | |
| 13 | Wichita | Kansas | United States | 67207 | |
| 14 | Kansas City | Missouri | United States | 64114 | |
| 15 | Springfield | Missouri | United States | 65802 | |
| 16 | St. Louis | Missouri | United States | 63110 | |
| 17 | Cary | North Carolina | United States | 27518 | |
| 18 | Raleigh | North Carolina | United States | 27609 | |
| 19 | Cincinnati | Ohio | United States | 45249 | |
| 20 | Bensalem | Pennsylvania | United States | 19020 | |
| 21 | Warwick | Rhode Island | United States | 02886 | |
| 22 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 23 | Fort Worth | Texas | United States | 76107 | |
| 24 | Galveston | Texas | United States | 77555 | |
| 25 | Salt Lake City | Utah | United States | 84109 | |
| 26 | Salt Lake City | Utah | United States | 84121 | |
| 27 | West Jordan | Utah | United States | 84088 | |
| 28 | Marshfield | Wisconsin | United States | 54449 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00775450
Other Study ID Numbers:
- FID21
First Posted:
Oct 20, 2008
Last Update Posted:
Dec 31, 2013
Last Verified:
Dec 1, 2013
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 14 October to 20 November 2008 in 27 medical centers in the US. |
|---|---|
| Pre-assignment Detail | A total of 807 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| Period Title: Overall Study | |||||
| STARTED | 295 | 98 | 105 | 108 | 201 |
| COMPLETED | 292 | 98 | 105 | 108 | 199 |
| NOT COMPLETED | 3 | 0 | 0 | 0 | 2 |
Baseline Characteristics
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) | Total of all reporting groups |
| Overall Participants | 295 | 98 | 105 | 108 | 201 | 807 |
| Age (Count of Participants) | ||||||
| <=18 years |
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%
|
| >=65 years |
295
100%
|
98
100%
|
105
100%
|
108
100%
|
201
100%
|
807
100%
|
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
73.9
(5.99)
|
74.2
(5.97)
|
73.0
(5.37)
|
74.3
(5.11)
|
73.5
(5.74)
|
73.8
(5.74)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
169
57.3%
|
54
55.1%
|
58
55.2%
|
61
56.5%
|
117
58.2%
|
459
56.9%
|
| Male |
126
42.7%
|
44
44.9%
|
47
44.8%
|
47
43.5%
|
84
41.8%
|
348
43.1%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
295
100%
|
98
100%
|
105
100%
|
108
100%
|
201
100%
|
807
100%
|
Outcome Measures
| Title | Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection |
|---|---|
| Description | Solicited injection site reactions: Pain, Erythema (redness), Swelling, Induration, Ecchymosis, Pruritus. Solicited systemic reactions: Fever, (Temperature), Headache, Malaise, Myalgia, and Shivering. |
| Time Frame | Days 0 through 7 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population. |
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| Measure Participants | 292 | 98 | 105 | 107 | 200 |
| Any Solicited Injection site Pain |
68
23.1%
|
18
18.4%
|
23
21.9%
|
31
28.7%
|
91
45.3%
|
| Grade 3 Pain (Incapacitating) |
2
0.7%
|
0
0%
|
0
0%
|
2
1.9%
|
1
0.5%
|
| Any Solicited Injection site Erythema |
207
70.2%
|
18
18.4%
|
9
8.6%
|
71
65.7%
|
34
16.9%
|
| Grade 3 Erythema (≥ 5 cm) |
34
11.5%
|
1
1%
|
0
0%
|
7
6.5%
|
7
3.5%
|
| Any Solicited Injection site Swelling |
127
43.1%
|
4
4.1%
|
3
2.9%
|
44
40.7%
|
23
11.4%
|
| Grade 3 Swelling (≥ 5 cm) |
9
3.1%
|
0
0%
|
0
0%
|
3
2.8%
|
5
2.5%
|
| Any Solicited Injection site Induration |
133
45.1%
|
6
6.1%
|
6
5.7%
|
50
46.3%
|
18
9%
|
| Grade 3 Induration (≥ 5 cm) |
5
1.7%
|
0
0%
|
0
0%
|
1
0.9%
|
1
0.5%
|
| Any Solicited Injection site Ecchymosis |
27
9.2%
|
2
2%
|
5
4.8%
|
11
10.2%
|
6
3%
|
| Grade 3 Ecchymosis (≥ 5 cm) |
1
0.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Solicited Injection site Pruritus |
99
33.6%
|
3
3.1%
|
6
5.7%
|
38
35.2%
|
20
10%
|
| Grade 3 Pruritus (Incapacitating) |
6
2%
|
0
0%
|
0
0%
|
1
0.9%
|
0
0%
|
| Any Fever |
9
3.1%
|
1
1%
|
1
1%
|
4
3.7%
|
7
3.5%
|
| Grade 3 Fever (>102.2 ºF) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Headache |
39
13.2%
|
14
14.3%
|
15
14.3%
|
17
15.7%
|
45
22.4%
|
| Grade 3 Headache (Prevents daily activities) |
1
0.3%
|
0
0%
|
0
0%
|
2
1.9%
|
1
0.5%
|
| Any Malaise |
31
10.5%
|
7
7.1%
|
18
17.1%
|
16
14.8%
|
36
17.9%
|
| Grade 3 Malaise (Prevents daily activities) |
1
0.3%
|
0
0%
|
0
0%
|
1
0.9%
|
2
1%
|
| Any Myalgia |
35
11.9%
|
18
18.4%
|
25
23.8%
|
22
20.4%
|
48
23.9%
|
| Grade 3 Myalgia (Prevents daily activities) |
0
0%
|
0
0%
|
0
0%
|
1
0.9%
|
2
1%
|
| Any Shivering |
12
4.1%
|
2
2%
|
5
4.8%
|
7
6.5%
|
9
4.5%
|
| Grade 3 Shivering (Prevents daily activities) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Geometric Mean Titers (GMTs) Before and After Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine Injection |
|---|---|
| Description | Serum antibody titers for the influenza vaccine serogroups A/H1N1, A/H3N2, and B were assessed by the hemagglutinin inhibition (HAI) assay. |
| Time Frame | Day 0 and Day 28 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| Measure Participants | 273 | 94 | 100 | 102 | 187 |
| A/H1N1 Pre-dose (Day 0,N = 273, 94, 100, 102, 186) |
28.7
|
23.5
|
27.3
|
20.8
|
28.7
|
| A/H1N1 Post -dose (Day 0 = 273, 94, 100, 102, 185) |
75.0
|
59.6
|
72.4
|
73.5
|
113
|
| A/H2N3 Pre-dose (Day 0, N= 273, 94, 100, 102, 186) |
30.8
|
28.7
|
24.5
|
28.1
|
36.6
|
| A/H2N3 Post Dose (n = 273, 94, 100, 102, 187) |
244
|
212
|
257
|
273
|
454
|
| B Pre Dose (n = 273, 94, 100, 102, 186 |
22.8
|
18.9
|
21.8
|
21.9
|
22.3
|
| B Post Dose (n = 273, 94, 100, 102, 185) |
54.3
|
51.4
|
60.4
|
51.1
|
78.2
|
| Title | Percentage of Participants Who Achieved Seroprotection Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine |
|---|---|
| Description | Seroprotection was defined as hemagglutinin inhibition (HAI) titer ≥ 1:40 at Day 28. |
| Time Frame | Days 0 and 28 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| Measure Participants | 273 | 94 | 100 | 102 | 187 |
| A/H1N1 Serogroup - (Day 0, Pre-dose) |
40
13.6%
|
36
36.7%
|
39
37.1%
|
26
24.1%
|
41
20.4%
|
| A/H1N1 Serogroup - (Day 28, Post-dose) |
80
27.1%
|
72
73.5%
|
80
76.2%
|
81
75%
|
88
43.8%
|
| A/H3N2 Serogroup - (Day 0, Pre-dose) |
49
16.6%
|
40
40.8%
|
38
36.2%
|
48
44.4%
|
50
24.9%
|
| A/H3N2 Serogroup - (Day 28, Post-dose) |
93
31.5%
|
86
87.8%
|
94
89.5%
|
91
84.3%
|
98
48.8%
|
| B Serogroup - (Day 0, Pre-dose) |
36
12.2%
|
29
29.6%
|
32
30.5%
|
32
29.6%
|
36
17.9%
|
| B Serogroup - (Day 28, Post-dose) |
73
24.7%
|
69
70.4%
|
75
71.4%
|
66
61.1%
|
83
41.3%
|
| Title | Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone Intramuscular or Fluzone High-dose Vaccine |
|---|---|
| Description | Seroconversion was defined as either a pre-vaccination hemagglutinin inhibition (HAI) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre- vaccination titer ≥ 1:10 and a minimum 4 fold increase at 28 days post vaccination. |
| Time Frame | Day 28 post vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Serum antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) |
| Measure Participants | 273 | 94 | 100 | 102 | 186 |
| A/H1N1 (N = 273, 94, 100, 102, 185) |
31
10.5%
|
28
28.6%
|
31
29.5%
|
44
40.7%
|
47
23.4%
|
| A/H2N3 (N = 273, 94, 100, 102, 186) |
73
24.7%
|
64
65.3%
|
76
72.4%
|
75
69.4%
|
84
41.8%
|
| B (N = 273, 94, 100, 102, 185) |
24
8.1%
|
31
31.6%
|
33
31.4%
|
26
24.1%
|
41
20.4%
|
Adverse Events
| Time Frame | Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD | |||||
| Arm/Group Description | Participants who received a dose (0.1 mL) of Fluzone intradermal (ID) after receiving Fluzone ID in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID29 NCT00551031) | Participants who received a dose (0.1 )Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID29 (NCT00551031) | Participants who received a dose (0.5 mL) of Fluzone High Dose (HD) vaccine after receiving Fluzone HD vaccine in Study FID29 (NCT00551031) | |||||
All Cause Mortality |
||||||||||
| Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/295 (3.4%) | 3/98 (3.1%) | 6/105 (5.7%) | 3/108 (2.8%) | 10/201 (5%) | |||||
| Cardiac disorders | ||||||||||
| Acute Myocardial Infarction | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 3/105 (2.9%) | 3 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Myocardial Infarction | 0/295 (0%) | 0 | 1/98 (1%) | 1 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Gastrointestinal disorders | ||||||||||
| Retroperitoneal Haematoma | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Small Intestinal Obstruction | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 1/105 (1%) | 1 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Umbilical Hernia | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Umbilical Hernia, Obstructive | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| General disorders | ||||||||||
| Chest Pain | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 1/105 (1%) | 1 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Non Cardiac Chest Pain | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Hepatobiliary disorders | ||||||||||
| Cholecystitis Acute | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 1/105 (1%) | 1 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Cholelithiasis | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 1/108 (0.9%) | 1 | 0/201 (0%) | 0 |
| Cholecystectomy | 0/295 (0%) | 0 | 1/98 (1%) | 1 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Infections and infestations | ||||||||||
| Bronchitis | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Bacterial Sepsis | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Gastroenteritis | 0/295 (0%) | 0 | 1/98 (1%) | 1 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Infective Exacerbation of Chronic Obstructive Airways Disease | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Lobar Pneumonia | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Otitis Media Chronic | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Pneumonia | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Humerus Fracture | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 1/108 (0.9%) | 1 | 0/201 (0%) | 0 |
| Pelvic Fracture | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Subdural Haematoma | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Tibia Fracture | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Arthritis | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 1/105 (1%) | 1 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Back Pain | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Acute Myeloid Leukemia | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Breast Cancer | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 1/108 (0.9%) | 1 | 1/201 (0.5%) | 1 |
| Prostate Cancer | 0/295 (0%) | 0 | 1/98 (1%) | 1 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Cerebral Cyst | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Cerebrovascular Accident | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Subarachnoid Haemorrhage | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Renal and urinary disorders | ||||||||||
| Renal Failure Acute | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||
| Endometrial Hyperplasia | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Asthma | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
| Pulmonary Oedema | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 1/105 (1%) | 1 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Vascular disorders | ||||||||||
| Haemorrhage | 1/295 (0.3%) | 1 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 0/201 (0%) | 0 |
| Hypertension | 0/295 (0%) | 0 | 0/98 (0%) | 0 | 0/105 (0%) | 0 | 0/108 (0%) | 0 | 1/201 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||
| Group 1a: Fluzone ID After Fluzone ID | Group 1b: Fluzone IM After Fluzone ID | Group 2a: Fluzone IM After Fluzone IM | Group 2b: Fluzone ID After Fluzone IM | Group 3: Fluzone HD After Fluzone HD | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 239/292 (81.8%) | 42/98 (42.9%) | 54/105 (51.4%) | 86/107 (80.4%) | 123/200 (61.5%) | |||||
| General disorders | ||||||||||
| Injection Site Pain | 68/292 (23.3%) | 68 | 18/98 (18.4%) | 18 | 23/105 (21.9%) | 23 | 31/107 (29%) | 31 | 91/200 (45.5%) | 91 |
| Injection Site Erythema | 207/292 (70.9%) | 207 | 18/98 (18.4%) | 18 | 9/105 (8.6%) | 9 | 71/107 (66.4%) | 71 | 34/200 (17%) | 34 |
| Injection Site Swelling | 127/292 (43.5%) | 127 | 4/98 (4.1%) | 4 | 3/105 (2.9%) | 3 | 44/107 (41.1%) | 44 | 23/200 (11.5%) | 23 |
| Injection Site Induration | 133/292 (45.5%) | 133 | 6/98 (6.1%) | 6 | 6/105 (5.7%) | 6 | 50/107 (46.7%) | 50 | 18/200 (9%) | 18 |
| Malaise | 31/292 (10.6%) | 31 | 7/98 (7.1%) | 7 | 18/105 (17.1%) | 18 | 16/107 (15%) | 16 | 36/200 (18%) | 36 |
| Shivering | 12/292 (4.1%) | 12 | 2/98 (2%) | 2 | 5/105 (4.8%) | 5 | 7/107 (6.5%) | 7 | 9/200 (4.5%) | 9 |
| Musculoskeletal and connective tissue disorders | ||||||||||
| Myalgia | 35/292 (12%) | 35 | 18/98 (18.4%) | 18 | 25/105 (23.8%) | 25 | 22/107 (20.6%) | 22 | 48/200 (24%) | 48 |
| Nervous system disorders | ||||||||||
| Headache | 39/292 (13.4%) | 39 | 14/98 (14.3%) | 14 | 15/105 (14.3%) | 15 | 17/107 (15.9%) | 17 | 45/200 (22.5%) | 45 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Injection Site Pruritus | 99/292 (33.9%) | 99 | 3/98 (3.1%) | 3 | 6/105 (5.7%) | 6 | 38/107 (35.5%) | 38 | 20/200 (10%) | 20 |
| Vascular disorders | ||||||||||
| Injection Site Ecchymosis | 27/292 (9.2%) | 27 | 2/98 (2%) | 2 | 5/105 (4.8%) | 5 | 11/107 (10.3%) | 11 | 6/200 (3%) | 6 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00775450
Other Study ID Numbers:
- FID21
First Posted:
Oct 20, 2008
Last Update Posted:
Dec 31, 2013
Last Verified:
Dec 1, 2013