A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00953524
Collaborator
(none)
849
15
4
16
56.6
3.5
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.
Primary Objectives:
-
To describe the immunogenicity of the candidate vaccines after each injection.
-
To describe the safety of the candidate vaccines after each injection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Study Design
Study Type:
Interventional
Actual Enrollment
:
849 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
Study Start Date
:
Aug 1, 2009
Actual Primary Completion Date
:
Mar 1, 2010
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A/H1N1 Vaccine Group 1 Participants will receive A/H1N1 vaccine formulation 1 |
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
0.5 mL, Intramuscular on Day 0 and on Day 21
|
| Experimental: A/H1N1 Vaccine Group 2 Participants will receive A/H1N1 vaccine formulation 2 |
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
0.5 mL, Intramuscular on Day 0 and Day 21
|
| Experimental: A/H1N1 Vaccine Group 3 Participants will receive A/H1N1 Vaccine formulation 3 |
Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
0.5 mL, Intramuscular on Day 0 and day 21
|
| Placebo Comparator: Placebo Group Participants will receive a placebo vaccine |
Biological: Normal saline solution (placebo)
0.5 mL, Intramuscular on Day 0 and Day 21
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [Pre-vaccination (Day 0) and day 21 post-vaccination]
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [Pre-vaccination (Day 0) and Day 21 post-vaccination]
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [Pre-vaccination (Day 0) and 21 days post-vaccination]
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years [Pre-vaccination (Day 0) and 21 days post-vaccination]
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years [Pre-vaccination (Day 0) and 21 days post-vaccination]
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years [Pre-vaccination (Day 0) and 21 days post-vaccination]
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
- Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years [Days 0 to 7 post-vaccination]
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
- Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years [Days 0 to 7 post-vaccination]
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria :
-
Healthy adults aged 18 years or older on the day of inclusion
-
Informed consent has been signed and dated
-
Able to attend all scheduled visits and comply with all trial procedures
-
For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.
Exclusion Criteria :
-
Known pregnancy or positive urine pregnancy test
-
Currently breastfeeding a child
-
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
-
Planned participation in another clinical trial during the present trial period
-
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
-
Planned receipt of any vaccine prior to the Day 42 blood sample
-
Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
-
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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
-
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
-
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
-
Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
-
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
-
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
-
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
-
Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
-
Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
-
Previous participation in a swine-origin H1N1 pandemic flu trial except if performed in 1976
-
Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
-
Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
-
Personal or family history of Guillain-Barré syndrome
-
Active neoplastic disease or a history of any hematologic malignancy
-
Known seizure/epilepsy history and/or taking anti-seizure medication
-
Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hoover | Alabama | United States | 35216 | |
| 2 | Chandler | Arizona | United States | 85224 | |
| 3 | Phoenix | Arizona | United States | 85020 | |
| 4 | Anaheim | California | United States | ||
| 5 | South Miami | Florida | United States | 33143 | |
| 6 | Maddisonville | Kentucky | United States | 42431 | |
| 7 | Springfield | Missouri | United States | 65802 | |
| 8 | Raleigh | North Carolina | United States | 27612 | |
| 9 | Cincinnati | Ohio | United States | 45227 | |
| 10 | Cleveland | Ohio | United States | 44122 | |
| 11 | Mt. Pleasant | South Carolina | United States | 29464 | |
| 12 | Knoxville | Tennessee | United States | 37920 | |
| 13 | Austin | Texas | United States | 78705 | |
| 14 | Salt Lake City | Utah | United States | 84124 | |
| 15 | Norfolk | Virginia | United States | 23507 |
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:
NCT00953524
Other Study ID Numbers:
- FUF14
- UTN: U1111-1111-4798
First Posted:
Aug 6, 2009
Last Update Posted:
Mar 10, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Sanofi Pasteur, a Sanofi Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers. |
|---|---|
| Pre-assignment Detail | A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Period Title: Overall Study | ||||
| STARTED | 249 | 254 | 247 | 99 |
| COMPLETED | 227 | 239 | 233 | 91 |
| NOT COMPLETED | 22 | 15 | 14 | 8 |
Baseline Characteristics
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | Total of all reporting groups |
| Overall Participants | 249 | 254 | 247 | 99 | 849 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
150
60.2%
|
152
59.8%
|
148
59.9%
|
49
49.5%
|
499
58.8%
|
| >=65 years |
99
39.8%
|
102
40.2%
|
99
40.1%
|
50
50.5%
|
350
41.2%
|
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
52.8
(19.2)
|
53.4
(18.9)
|
54.4
(18.4)
|
56.4
(18.1)
|
53.4
(18.9)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
140
56.2%
|
143
56.3%
|
145
58.7%
|
57
57.6%
|
485
57.1%
|
| Male |
109
43.8%
|
111
43.7%
|
102
41.3%
|
42
42.4%
|
364
42.9%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
249
100%
|
254
100%
|
247
100%
|
99
100%
|
849
100%
|
Outcome Measures
| Title | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years |
|---|---|
| Description | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and day 21 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre- and post-vaccination antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 124 | 128 | 132 | 45 |
| Pre-Vaccination 1 (Day 0) Titers at ≥ 10 |
69
27.7%
|
70
27.6%
|
61
24.7%
|
23
23.2%
|
| Post-Vaccination 1 (Day 21) Titers at ≥ 10 |
124
49.8%
|
127
50%
|
132
53.4%
|
21
21.2%
|
| Post-Vaccination 2 (Day 42) Titers at ≥ 10 |
124
49.8%
|
128
50.4%
|
132
53.4%
|
22
22.2%
|
| Title | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years |
|---|---|
| Description | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and Day 21 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 124 | 128 | 132 | 45 |
| Pre-Vaccination 1 (Day 0) Titers at ≥ 40 |
27
10.8%
|
37
14.6%
|
32
13%
|
11
11.1%
|
| Post-Vaccination 1 (Day 21) Titers at ≥ 40 |
118
47.4%
|
126
49.6%
|
132
53.4%
|
10
10.1%
|
| Post-Vaccination 2 (Day 42) Titers at ≥ 40 |
124
49.8%
|
127
50%
|
131
53%
|
11
11.1%
|
| Title | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years |
|---|---|
| Description | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and 21 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 124 | 128 | 132 | 45 |
| Pre-Vaccination 1 (Day 0) GMT |
14.5
|
17.3
|
14.1
|
14.0
|
| Post-Vaccination 1 (Day 21) GMT |
708
|
1362
|
1526
|
13.1
|
| Post-Vaccination 2 (Day 42) GMT |
800
|
1329
|
1331
|
13.5
|
| Title | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years |
|---|---|
| Description | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and 21 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre- and post-vaccination antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 87 | 87 | 85 | 39 |
| Pre-Vaccination 1 (Day 0) Titers at ≥ 10 |
64
25.7%
|
54
21.3%
|
60
24.3%
|
24
24.2%
|
| Post-Vaccination 1 (Day 21) Titers at ≥ 10 |
87
34.9%
|
87
34.3%
|
85
34.4%
|
23
23.2%
|
| Post-Vaccination 2 (Day 42) Titers at ≥ 10 |
87
34.9%
|
87
34.3%
|
85
34.4%
|
26
26.3%
|
| Title | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years |
|---|---|
| Description | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and 21 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre- and post-vaccination antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 87 | 87 | 85 | 39 |
| Pre-Vaccination 1 (Day 0) Titers at ≥ 40 |
21
8.4%
|
21
8.3%
|
24
9.7%
|
10
10.1%
|
| Post-Vaccination 1 (Day 21) Titers at ≥ 40 |
82
32.9%
|
80
31.5%
|
80
32.4%
|
9
9.1%
|
| Post-Vaccination 2 (Day 42) Titers at ≥ 40 |
85
34.1%
|
83
32.7%
|
85
34.4%
|
10
10.1%
|
| Title | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years |
|---|---|
| Description | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Time Frame | Pre-vaccination (Day 0) and 21 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 87 | 87 | 85 | 39 |
| Pre-Vaccination 1 (Day 0) GMT |
19.1
|
14.7
|
18.3
|
17.5
|
| Post-Vaccination 1 (Day 21) GMT |
319
|
423
|
578
|
17.5
|
| Post-Vaccination 2 (Day 42) GMT |
359
|
416
|
604
|
19.0
|
| Title | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). |
| Time Frame | Days 0 to 7 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 149 | 152 | 149 | 49 |
| Any Solicited Injection Site Reaction - Any Dose |
65
26.1%
|
60
23.6%
|
73
29.6%
|
9
9.1%
|
| Grade 3 Injection Site Reaction - Any Dose |
4
1.6%
|
1
0.4%
|
2
0.8%
|
0
0%
|
| Any Pain - Post Dose 1 |
53
21.3%
|
43
16.9%
|
48
19.4%
|
8
8.1%
|
| Any Pain - Post Dose 2 |
39
15.7%
|
42
16.5%
|
56
22.7%
|
4
4%
|
| Any Pain - Any Dose |
64
25.7%
|
59
23.2%
|
72
29.1%
|
9
9.1%
|
| Grade 3 Pain (Prevents daily activity) - Any Dose |
4
1.6%
|
1
0.4%
|
2
0.8%
|
0
0%
|
| Any Erythema - Post Dose 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Erythema - Post Dose 2 |
0
0%
|
0
0%
|
2
0.8%
|
0
0%
|
| Any Erythema - Any Dose |
0
0%
|
0
0%
|
2
0.8%
|
0
0%
|
| Grade 3 Erythema (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Swelling - Post Dose 1 |
1
0.4%
|
2
0.8%
|
2
0.8%
|
0
0%
|
| Any Swelling - Post Dose 2 |
0
0%
|
2
0.8%
|
2
0.8%
|
0
0%
|
| Any Swelling - Any Dose |
1
0.4%
|
3
1.2%
|
3
1.2%
|
0
0%
|
| Grade 3 Swelling (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Induration - Post Dose 1 |
1
0.4%
|
1
0.4%
|
1
0.4%
|
0
0%
|
| Any Induration - Post Dose 2 |
0
0%
|
2
0.8%
|
2
0.8%
|
0
0%
|
| Any Induration - Any Dose |
1
0.4%
|
2
0.8%
|
2
0.8%
|
0
0%
|
| Grade 3 Induration (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Ecchymosis - Post Dose 1 |
1
0.4%
|
1
0.4%
|
0
0%
|
0
0%
|
| Any Ecchymosis - Post Dose 2 |
1
0.4%
|
1
0.4%
|
1
0.4%
|
0
0%
|
| Any Ecchymosis - Any Dose |
2
0.8%
|
1
0.4%
|
1
0.4%
|
0
0%
|
| Grade 3 Ecchymosis (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Solicited Systemic Reaction - Any Dose |
81
32.5%
|
73
28.7%
|
78
31.6%
|
24
24.2%
|
| Any Grade 3 Solicited Systemic Reaction - Any Dose |
10
4%
|
6
2.4%
|
3
1.2%
|
4
4%
|
| Any Fever - Post Dose 1 |
1
0.4%
|
1
0.4%
|
2
0.8%
|
1
1%
|
| Any Fever - Post Dose 2 |
1
0.4%
|
0
0%
|
1
0.4%
|
0
0%
|
| Any Fever - Any Dose |
2
0.8%
|
1
0.4%
|
2
0.8%
|
1
1%
|
| Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose |
1
0.4%
|
0
0%
|
0
0%
|
1
1%
|
| Any Headache - Post Dose 1 |
48
19.3%
|
48
18.9%
|
40
16.2%
|
16
16.2%
|
| Any Headache - Post Dose 2 |
36
14.5%
|
21
8.3%
|
31
12.6%
|
11
11.1%
|
| Any Headache - Any Dose |
60
24.1%
|
55
21.7%
|
53
21.5%
|
19
19.2%
|
| Grd 3 Headache (Prevents daily activity), Any Dose |
5
2%
|
5
2%
|
2
0.8%
|
3
3%
|
| Any Malaise - Post Dose 1 |
34
13.7%
|
23
9.1%
|
27
10.9%
|
9
9.1%
|
| Any Malaise - Post Dose 2 |
22
8.8%
|
15
5.9%
|
25
10.1%
|
6
6.1%
|
| Any Malaise - Any Dose |
43
17.3%
|
31
12.2%
|
42
17%
|
13
13.1%
|
| Grd 3 Malaise (Prevents daily activity) - Any Dose |
6
2.4%
|
3
1.2%
|
2
0.8%
|
2
2%
|
| Any Myalgia - Post Dose 1 |
43
17.3%
|
30
11.8%
|
33
13.4%
|
11
11.1%
|
| Any Myalgia - Post Dose 2 |
22
8.8%
|
16
6.3%
|
26
10.5%
|
5
5.1%
|
| Any Myalgia - Any Dose |
49
19.7%
|
34
13.4%
|
49
19.8%
|
13
13.1%
|
| Grd 3 Myalgia (Prevents daily activity) - Any Dose |
6
2.4%
|
2
0.8%
|
0
0%
|
2
2%
|
| Any Shivering - Post Dose 1 |
10
4%
|
2
0.8%
|
8
3.2%
|
2
2%
|
| Any Shivering - Post Dose 2 |
2
0.8%
|
0
0%
|
3
1.2%
|
0
0%
|
| Any Shivering - Any Dose |
12
4.8%
|
2
0.8%
|
9
3.6%
|
2
2%
|
| Grade 3 Shivering (Prevents activity) - Any Dose |
1
0.4%
|
0
0%
|
0
0%
|
1
1%
|
| Title | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years |
|---|---|
| Description | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). |
| Time Frame | Days 0 to 7 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. |
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
|---|---|---|---|---|
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| Measure Participants | 99 | 102 | 99 | 50 |
| Any Solicited Injection Site Reaction - Any Dose |
20
8%
|
19
7.5%
|
27
10.9%
|
2
2%
|
| Grade 3 Injection Site Reaction - Any Dose |
0
0%
|
0
0%
|
1
0.4%
|
0
0%
|
| Any Pain - Post Dose 1 |
10
4%
|
12
4.7%
|
16
6.5%
|
0
0%
|
| Any Pain - Post Dose 2 |
10
4%
|
14
5.5%
|
16
6.5%
|
2
2%
|
| Any Pain - Any Dose |
18
7.2%
|
19
7.5%
|
24
9.7%
|
2
2%
|
| Grade 3 Pain (Prevents daily activity) - Any Dose |
0
0%
|
0
0%
|
1
0.4%
|
0
0%
|
| Any Erythema - Post Dose 1 |
1
0.4%
|
0
0%
|
1
0.4%
|
0
0%
|
| Any Erythema - Post Dose 2 |
1
0.4%
|
0
0%
|
2
0.8%
|
0
0%
|
| Any Erythema - Any Dose |
2
0.8%
|
0
0%
|
3
1.2%
|
0
0%
|
| Grade 3 Erythema (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Swelling - Post Dose 1 |
0
0%
|
0
0%
|
2
0.8%
|
0
0%
|
| Any Swelling - Post Dose 2 |
0
0%
|
0
0%
|
2
0.8%
|
1
1%
|
| Any Swelling - Any Dose |
0
0%
|
0
0%
|
3
1.2%
|
1
1%
|
| Grade 3 Swelling (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Induration - Post Dose 1 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Induration - Post Dose 2 |
0
0%
|
1
0.4%
|
0
0%
|
0
0%
|
| Any Induration - Any Dose |
0
0%
|
1
0.4%
|
0
0%
|
0
0%
|
| Grade 3 Induration (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Ecchymosis - Post Dose 1 |
2
0.8%
|
0
0%
|
2
0.8%
|
0
0%
|
| Any Ecchymosis - Post Dose 2 |
0
0%
|
1
0.4%
|
0
0%
|
1
1%
|
| Any Ecchymosis - Any Dose |
2
0.8%
|
1
0.4%
|
2
0.8%
|
1
1%
|
| Grade 3 Ecchymosis (> 10 cm) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Solicited Systemic Reaction - Any Dose |
28
11.2%
|
22
8.7%
|
32
13%
|
13
13.1%
|
| Any Grade 3 Solicited Systemic Reaction - Any Dose |
2
0.8%
|
1
0.4%
|
1
0.4%
|
0
0%
|
| Any Fever - Post Dose 1 |
0
0%
|
0
0%
|
1
0.4%
|
1
1%
|
| Any Fever - Post Dose 2 |
0
0%
|
0
0%
|
0
0%
|
1
1%
|
| Any Fever - Any Dose |
0
0%
|
0
0%
|
1
0.4%
|
2
2%
|
| Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Any Headache - Post Dose 1 |
11
4.4%
|
10
3.9%
|
16
6.5%
|
6
6.1%
|
| Any Headache - Post Dose 2 |
9
3.6%
|
7
2.8%
|
8
3.2%
|
9
9.1%
|
| Any Headache - Any Dose |
16
6.4%
|
13
5.1%
|
21
8.5%
|
11
11.1%
|
| Grd 3 Headache (Prevents daily activity), Any Dose |
1
0.4%
|
0
0%
|
0
0%
|
0
0%
|
| Any Malaise - Post Dose 1 |
4
1.6%
|
7
2.8%
|
15
6.1%
|
4
4%
|
| Any Malaise - Post Dose 2 |
11
4.4%
|
4
1.6%
|
7
2.8%
|
5
5.1%
|
| Any Malaise - Any Dose |
14
5.6%
|
9
3.5%
|
21
8.5%
|
8
8.1%
|
| Grd 3 Malaise (Prevents daily activity) - Any Dose |
1
0.4%
|
0
0%
|
1
0.4%
|
0
0%
|
| Any Myalgia - Post Dose 1 |
7
2.8%
|
9
3.5%
|
11
4.5%
|
2
2%
|
| Any Myalgia - Post Dose 2 |
5
2%
|
10
3.9%
|
8
3.2%
|
5
5.1%
|
| Any Myalgia - Any Dose |
11
4.4%
|
16
6.3%
|
17
6.9%
|
6
6.1%
|
| Grd 3 Myalgia (Prevents daily activity) - Any Dose |
1
0.4%
|
1
0.4%
|
1
0.4%
|
0
0%
|
| Any Shivering - Post Dose 1 |
1
0.4%
|
0
0%
|
2
0.8%
|
1
1%
|
| Any Shivering - Post Dose 2 |
2
0.8%
|
3
1.2%
|
0
0%
|
2
2%
|
| Any Shivering - Any Dose |
3
1.2%
|
3
1.2%
|
2
0.8%
|
3
3%
|
| Grade 3 Shivering (Prevents activity) - Any Dose |
1
0.4%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | ||||
| Arm/Group Description | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | ||||
All Cause Mortality |
||||||||
| A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/248 (3.2%) | 7/254 (2.8%) | 7/248 (2.8%) | 4/99 (4%) | ||||
| Cardiac disorders | ||||||||
| Angina Pectoris | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Coronary artery disease | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 2/248 (0.8%) | 3 | 0/99 (0%) | 0 |
| Myocardial infarction | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Femoral hernia | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 1/99 (1%) | 1 |
| Large intestine perforation | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| General disorders | ||||||||
| Non-cardiac chest pain | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Infections and infestations | ||||||||
| Cellulitis | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Diverticulitis | 0/248 (0%) | 0 | 1/254 (0.4%) | 2 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Gastroenteritis | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Gastroenteritis viral | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Pneumonia bacterial | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Ankle fracture | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Multiple fractures | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Skin laceration | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Upper limb fracture | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Diabetes mellitus | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 1/99 (1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Intervertebral disc protrusion | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Lung neoplasm malignan | 0/248 (0%) | 0 | 1/254 (0.4%) | 2 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Non-Hodgkins lymphoma | 0/248 (0%) | 0 | 1/254 (0.4%) | 2 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Oesophageal carcinoma | 1/248 (0.4%) | 2 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Rectal cancer | 1/248 (0.4%) | 2 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Sarcoma | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Nervous system disorders | ||||||||
| Carotid artery stenosis | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 1/248 (0.4%) | 1 | 0/99 (0%) | 0 |
| Cerebrovascular accident | 0/248 (0%) | 0 | 1/254 (0.4%) | 1 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Global amnesia | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Myasthenia gravis | 1/248 (0.4%) | 1 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 0/99 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pleural effusion | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 1/99 (1%) | 1 |
| Vascular disorders | ||||||||
| Aortic aneurysm | 0/248 (0%) | 0 | 0/254 (0%) | 0 | 0/248 (0%) | 0 | 1/99 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 82/248 (33.1%) | 78/254 (30.7%) | 96/248 (38.7%) | 30/99 (30.3%) | ||||
| General disorders | ||||||||
| Injection site pain | 82/242 (33.9%) | 78/249 (31.3%) | 96/246 (39%) | 11/98 (11.2%) | ||||
| Malaise | 57/242 (23.6%) | 40/249 (16.1%) | 63/246 (25.6%) | 21/99 (21.2%) | ||||
| Shivering | 15/242 (6.2%) | 15/249 (6%) | 11/246 (4.5%) | 5/99 (5.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Myalgia | 60/242 (24.8%) | 50/249 (20.1%) | 66/246 (26.8%) | 19/99 (19.2%) | ||||
| Nervous system disorders | ||||||||
| Headache | 76/242 (31.4%) | 68/249 (27.3%) | 74/246 (30.1%) | 30/99 (30.3%) | ||||
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:
NCT00953524
Other Study ID Numbers:
- FUF14
- UTN: U1111-1111-4798
First Posted:
Aug 6, 2009
Last Update Posted:
Mar 10, 2014
Last Verified:
Feb 1, 2014