Influenza, Swine-origin A/H1N1 Influenza
Conditions
Keywords
Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Adult
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.
Detailed description
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Interventions
BIOLOGICALMonovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA)
0.5 mL, Intramuscular on Day 0 and on Day 21
BIOLOGICALMonovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA)
0.5 mL, Intramuscular on Day 0 and Day 21
BIOLOGICALMonovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA)
0.5 mL, Intramuscular on Day 0 and day 21
BIOLOGICALNormal saline solution (placebo)
0.5 mL, Intramuscular on Day 0 and Day 21
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.
Pre-assignment details
A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants by arm
| Arm | Count |
|---|---|
| A/H1N1 Vaccine Group 1 Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | 249 |
| A/H1N1 Vaccine Group 2 Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | 254 |
| A/H1N1 Vaccine Group 3 Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | 247 |
| Placebo Group Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | 99 |
| Total | 849 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 18 | 10 | 11 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | A/H1N1 Vaccine Group 1 | Placebo Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 102 Participants | 99 Participants | 99 Participants | 50 Participants | 350 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants | 148 Participants | 150 Participants | 49 Participants | 499 Participants |
| Age, Continuous | 53.4 Years STANDARD_DEVIATION 18.9 | 54.4 Years STANDARD_DEVIATION 18.4 | 52.8 Years STANDARD_DEVIATION 19.2 | 56.4 Years STANDARD_DEVIATION 18.1 | 53.4 Years STANDARD_DEVIATION 18.9 |
| Region of Enrollment United States | 254 participants | 247 participants | 249 participants | 99 participants | 849 participants |
| Sex: Female, Male Female | 143 Participants | 145 Participants | 140 Participants | 57 Participants | 485 Participants |
| Sex: Female, Male Male | 111 Participants | 102 Participants | 109 Participants | 42 Participants | 364 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 82 / 248 | 78 / 254 | 96 / 248 | 30 / 99 |
| serious Total, serious adverse events | 8 / 248 | 7 / 254 | 7 / 248 | 4 / 99 |
Outcome results
Primary
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
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
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) GMT | 14.5 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) GMT | 800 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) GMT | 708 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) GMT | 17.3 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) GMT | 1329 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) GMT | 1362 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) GMT | 1526 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) GMT | 14.1 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) GMT | 1331 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) GMT | 14.0 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) GMT | 13.5 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) GMT | 13.1 Titers |
Primary
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
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
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) GMT | 19.1 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) GMT | 359 Titers |
| A/H1N1 Vaccine Group 1 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) GMT | 319 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) GMT | 14.7 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) GMT | 416 Titers |
| A/H1N1 Vaccine Group 2 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) GMT | 423 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) GMT | 578 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) GMT | 18.3 Titers |
| A/H1N1 Vaccine Group 3 | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) GMT | 604 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) GMT | 17.5 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) GMT | 19.0 Titers |
| Placebo Group | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) GMT | 17.5 Titers |
Primary
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
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
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 64 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 87 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 87 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 54 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 87 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 87 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 85 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 60 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 85 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 24 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 26 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 23 Participants |
Primary
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
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
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 69 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 124 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 124 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 70 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 128 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 127 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 132 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 61 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 132 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 10 | 23 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 10 | 22 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 10 | 21 Participants |
Primary
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
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
Population: Antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 27 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 124 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 118 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 37 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 127 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 126 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 132 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 32 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 131 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 11 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 11 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 10 Participants |
Primary
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
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
Population: Pre- and post-vaccination antibody titers were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 21 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 85 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 82 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 21 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 83 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 80 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 80 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 24 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 85 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-Vaccination 1 (Day 0) Titers at ≥ 40 | 10 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 2 (Day 42) Titers at ≥ 40 | 10 Participants |
| Placebo Group | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Post-Vaccination 1 (Day 21) Titers at ≥ 40 | 9 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
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
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 1 | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 1 | 53 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Any Dose | 49 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 2 | 22 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 2 | 39 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Injection Site Reaction - Any Dose | 65 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 1 | 43 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Any Dose | 64 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Any Dose | 43 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 2 | 22 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 1 | 34 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Any Dose | 12 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Any Dose | 60 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 2 | 36 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 1 | 48 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Injection Site Reaction - Any Dose | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Systemic Reaction - Any Dose | 81 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Any Dose | 59 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Injection Site Reaction - Any Dose | 60 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Injection Site Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 1 | 43 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 2 | 42 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Systemic Reaction - Any Dose | 73 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 6 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 1 | 48 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 2 | 21 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Any Dose | 55 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 5 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 1 | 23 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 2 | 15 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Any Dose | 31 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 1 | 30 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 2 | 16 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Any Dose | 34 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 2 | 25 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Injection Site Reaction - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Any Dose | 72 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Any Dose | 42 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 1 | 40 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 2 | 56 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Injection Site Reaction - Any Dose | 73 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 1 | 33 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 2 | 31 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 1 | 8 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Any Dose | 53 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Any Dose | 49 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 2 | 26 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Systemic Reaction - Any Dose | 78 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 1 | 48 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 1 | 27 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Any Dose | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Any Dose | 13 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Injection Site Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Fever - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 F or ≥ 39.0 C) - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 1 | 16 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Erythema - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Systemic Reaction - Any Dose | 24 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Post Dose 2 | 11 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Headache - Any Dose | 19 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 1 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Solicited Injection Site Reaction - Any Dose | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 1 | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Any Dose | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Post Dose 2 | 6 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Malaise - Any Dose | 13 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 2 | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Shivering - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 1 | 11 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Pain - Post Dose 1 | 8 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Induration - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Swelling - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Myalgia - Post Dose 2 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Any Ecchymosis - Any Dose | 0 Participants |
Primary
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
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
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Injection Site Reaction - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 1 | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Any Dose | 11 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 2 | 5 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 2 | 10 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Any Dose | 14 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Any Dose | 18 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 2 | 11 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 1 | 4 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 1 | 7 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Any Dose | 16 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Injection Site Reaction - Any Dose | 20 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 2 | 9 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 1 | 11 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 1 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Systemic Reaction - Any Dose | 28 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Injection Site Reaction - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 1 | 10 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Injection Site Reaction - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 1 | 12 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 2 | 14 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Any Dose | 19 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Systemic Reaction - Any Dose | 22 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 2 | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Any Dose | 13 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 1 | 7 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 2 | 4 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Any Dose | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 1 | 9 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 2 | 10 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Any Dose | 16 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 2 | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 2 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Injection Site Reaction - Any Dose | 27 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Any Dose | 24 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 2 | 7 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Any Dose | 21 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 1 | 16 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 2 | 16 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 1 | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Injection Site Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 1 | 11 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 2 | 8 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Systemic Reaction - Any Dose | 32 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 1 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Any Dose | 21 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 2 | 8 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Any Dose | 1 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Any Dose | 3 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 1 | 16 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 2 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Any Dose | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 2 | 0 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 1 | 15 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 1 | 2 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Any Dose | 17 Participants |
| A/H1N1 Vaccine Group 3 | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Induration (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Any Dose | 6 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Injection Site Reaction - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Solicited Systemic Reaction - Any Dose | 13 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Any Dose | 3 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Grade 3 Solicited Systemic Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Myalgia (Prevents daily activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Fever - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Erythema - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 1 | 6 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Post Dose 2 | 9 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Pain (Prevents daily activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Headache - Any Dose | 11 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 1 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Headache (Prevents daily activity), Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Any Dose | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 1 | 4 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Shivering (Prevents activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Post Dose 2 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Malaise - Any Dose | 8 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Shivering - Post Dose 2 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grd 3 Malaise (Prevents daily activity) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Injection Site Reaction - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 1 | 2 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Pain - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Post Dose 2 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Induration - Any Dose | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 2 | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Myalgia - Post Dose 2 | 5 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Any Dose | 1 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Swelling - Post Dose 1 | 0 Participants |
| Placebo Group | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Any Ecchymosis - Post Dose 2 | 1 Participants |