Influenza, Swine-origin A/H1N1 Influenza
Conditions
Keywords
Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults
Brief summary
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: * To describe the immunogenicity of the candidate vaccines after a single injection. * To describe the safety of the candidate vaccines after a single injection.
Detailed description
Participants will receive a single injection of their randomized vaccine on Day 0.
Interventions
BIOLOGICALMonovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
0.5 mL, Intramuscular on Day 0
BIOLOGICALNormal saline solution
0.5 mL, Intramuscular on Day 0
Sponsors
Sanofi
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, except for the inactivated seasonal influenza vaccine, within two weeks preceding 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 A/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 * Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening * Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening * Receipt of any monovalent 2009 pandemic H1N1 vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination. |
| Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). |
| Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. |
| Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil). |
| Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). |
| Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 and Day 21 post-vaccination | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 up to Day 7 post-vaccination | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 up to Day 7 post-vaccination | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 29 October 2009 to 13 November 2009 at 14 US clinical centers.
Pre-assignment details
A total of 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 | 127 |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 | 115 |
| Group 3: A/H1N1 Vaccine Formulation 3 Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 | 122 |
| Group 4: A/H1N1 Vaccine Formulation 4 Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 | 121 |
| Group 5: Placebo Participants who received a dose of placebo (normal saline) on Day 0 | 63 |
| Total | 548 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Group 3: A/H1N1 Vaccine Formulation 3 | Group 4: A/H1N1 Vaccine Formulation 4 | Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Group 5: Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 49 Participants | 50 Participants | 52 Participants | 25 Participants | 222 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 73 Participants | 71 Participants | 75 Participants | 38 Participants | 326 Participants |
| Age Continuous Age Continuous | 53.3 Years STANDARD_DEVIATION 18.7 | 51.9 Years STANDARD_DEVIATION 18 | 52.7 Years STANDARD_DEVIATION 19.9 | 54.0 Years STANDARD_DEVIATION 18.4 | 54.7 Years STANDARD_DEVIATION 16.7 | 53.4 Years STANDARD_DEVIATION 18.34 |
| Region of Enrollment United States | 115 Participants | 122 Participants | 121 Participants | 127 Participants | 63 Participants | 548 Participants |
| Sex: Female, Male Female | 65 Participants | 66 Participants | 68 Participants | 79 Participants | 45 Participants | 323 Participants |
| Sex: Female, Male Male | 50 Participants | 56 Participants | 53 Participants | 48 Participants | 18 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 77 / 127 | 75 / 115 | 75 / 122 | 82 / 121 | 40 / 63 |
| serious Total, serious adverse events | 6 / 127 | 5 / 115 | 5 / 122 | 4 / 121 | 5 / 63 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 23.7 Titers |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 896 Titers |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 21.0 Titers |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 900 Titers |
| Group 3: A/H1N1 Vaccine Formulation 3 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 23.8 Titers |
| Group 3: A/H1N1 Vaccine Formulation 3 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 470 Titers |
| Group 4: A/H1N1 Vaccine Formulation 4 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 608 Titers |
| Group 4: A/H1N1 Vaccine Formulation 4 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 27.7 Titers |
| Group 5: Placebo | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 20.0 Titers |
| Group 5: Placebo | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 26.3 Titers |
Primary
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 28.5 Titers |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 501 Titers |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 40.0 Titers |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 630 Titers |
| Group 3: A/H1N1 Vaccine Formulation 3 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 26.1 Titers |
| Group 3: A/H1N1 Vaccine Formulation 3 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 177 Titers |
| Group 4: A/H1N1 Vaccine Formulation 4 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 189 Titers |
| Group 4: A/H1N1 Vaccine Formulation 4 | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 23.0 Titers |
| Group 5: Placebo | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 25.7 Titers |
| Group 5: Placebo | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 26.8 Titers |
Primary
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Headache | 36 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Shivering (Prevents daily activity) | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Ecchymosis | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Fever | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Erythema | 2 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Pain | 52 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Shivering | 6 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Myalgia (Prevents daily activity) | 3 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Swelling | 3 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Myalgia | 36 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Malaise (Prevents daily activity) | 3 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Induration | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Malaise | 29 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Headache (Prevents daily activity) | 2 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Ecchymosis | 4 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Pain | 53 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Swelling | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Shivering (Prevents daily activity) | 2 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Induration | 3 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Ecchymosis | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Shivering | 7 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Fever | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Malaise (Prevents daily activity) | 3 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) | 2 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Erythema | 2 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Myalgia (Prevents daily activity) | 4 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Headache (Prevents daily activity) | 3 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Headache | 27 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Malaise | 21 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Myalgia | 28 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Erythema | 2 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Pain | 13 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) | 1 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Ecchymosis | 1 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Ecchymosis | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Fever | 3 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Headache | 25 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Headache (Prevents daily activity) | 1 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Malaise | 20 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Malaise (Prevents daily activity) | 3 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Myalgia | 12 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Myalgia (Prevents daily activity) | 3 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Shivering | 6 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Shivering (Prevents daily activity) | 1 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Headache | 24 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Pain | 17 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Myalgia | 17 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Malaise | 12 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Myalgia (Prevents daily activity) | 2 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Shivering | 6 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Erythema | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Ecchymosis | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Headache (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Fever | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Malaise (Prevents daily activity) | 2 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Headache | 15 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Shivering | 3 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Headache (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Malaise | 8 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Pain | 11 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Malaise (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Myalgia | 12 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Erythema | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Myalgia (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Ecchymosis | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Pain (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Fever | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
Primary
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Time frame: Day 0 up to Day 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Shivering | 2 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Headache | 10 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Erythema | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Fever | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Pain | 21 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Shivering (Prevents daily activity) | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Myalgia (Prevents daily activity) | 1 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Myalgia | 12 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Malaise (Prevents daily activity) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Induration | 2 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Malaise | 8 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Headache (Prevents daily activity) | 2 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Induration | 2 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Swelling | 3 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Pain | 22 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Shivering | 3 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Malaise (Prevents daily activity) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Headache (Prevents daily activity) | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Fever | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Erythema | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Pain (Prevents daily activities) | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Myalgia (Prevents daily activity) | 1 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Headache | 10 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Malaise | 4 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Myalgia | 11 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Myalgia (Prevents daily activity) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Pain | 2 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Erythema | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Ecchymosis | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Fever | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Headache | 5 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Headache (Prevents daily activity) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Malaise | 3 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Malaise (Prevents daily activity) | 0 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Myalgia | 3 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Shivering | 1 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Ecchymosis | 2 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Shivering | 3 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Headache | 10 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Headache (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Malaise | 5 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Pain | 7 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Malaise (Prevents daily activity) | 1 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Myalgia | 7 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Erythema | 1 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Myalgia (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Fever | 1 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Pain (Prevents daily activities) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Induration (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Erythema (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Shivering (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Headache | 3 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Ecchymosis (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Induration | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Shivering | 1 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Myalgia | 2 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Headache (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Fever (≥ 102.1 ºF or ≥ 39.0 ºC) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Swelling (> 10 cm) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Pain | 2 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Erythema | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Malaise | 1 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Ecchymosis | 1 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Solicited Injection Site Swelling | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Any Fever | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Myalgia (Prevents daily activity) | 0 Participants |
| Group 5: Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Grade 3 Malaise (Prevents daily activity) | 0 Participants |
Primary
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 44 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 71 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 41 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 67 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 51 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 71 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 68 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 46 Participants |
| Group 5: Placebo | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 22 Participants |
| Group 5: Placebo | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 27 Participants |
Primary
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 35 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 50 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 39 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 45 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 37 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 46 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 50 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 38 Participants |
| Group 5: Placebo | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 19 Participants |
| Group 5: Placebo | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 18 Participants |
Primary
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 25 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 71 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 24 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 66 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 26 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 67 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 64 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 27 Participants |
| Group 5: Placebo | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 0 (Pre-vaccination) | 11 Participants |
| Group 5: Placebo | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Day 21 (Post-vaccination) | 13 Participants |
Primary
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Time frame: Day 0 and Day 21 post-vaccination
Population: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 23 Participants |
| Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 48 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 21 Participants |
| Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 44 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 19 Participants |
| Group 3: A/H1N1 Vaccine Formulation 3 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 40 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 40 Participants |
| Group 4: A/H1N1 Vaccine Formulation 4 | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 20 Participants |
| Group 5: Placebo | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 0 (Pre-vaccination) | 9 Participants |
| Group 5: Placebo | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Day 21 (Post-vaccination) | 9 Participants |