Influenza
Conditions
Brief summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered. Subjects will be randomized according to a randomization scheme.
Detailed description
All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.
Interventions
BIOLOGICALInfluenza A Vaccine: ACAM FLU-A
0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
BIOLOGICALSaline placebo
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult males or females 18 - 40 years of age in good general health
Exclusion criteria
* Known allergies or severe reactions to any of the vaccine components including those to adjuvants * History of severe allergic reactions, including angioedema; * History of asthma or recurrent wheezing; (current or within past 2 years); * History of neurological symptoms or signs following administration of any vaccine;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 0 through Day 60 post-vaccination | — |
| Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 through Day 7 post-vaccination | Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased. |
| Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 through Day 60 post-vaccination 1 | — |
| Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 15 through Month 10 Post-vaccination 1 | Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA) |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 15 through Month 10 Post-vaccination 1 | Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 4 through Month 10 post-vaccination 1 | Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies. |
| Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 and Day 15 through Month 10 Post-vaccination 1 | Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods |
| Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 and Day 60 Post-vaccination 1 | Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA) |
| Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 and Day 60 Post-vaccination 1 | Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ). |
| Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 and Day 60 Post-vaccination 1 | Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). |
| Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 and Day 15 through Month 10 post-vaccination 1 | Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA) |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.
Pre-assignment details
A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. | 22 |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. | 23 |
| ACAM FLU A Without Adjuvant Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. | 21 |
| Saline Placebo Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. | 21 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 2 |
| Overall Study | Not meeting continuing study eligibility | 2 | 1 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | ACAM FLU A Without Adjuvant | ACAM-FLU-A Adjuvanted With Alhydrogel | Saline Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 21 Participants | 22 Participants | 21 Participants | 87 Participants |
| Age Continuous | 27.7 Years STANDARD_DEVIATION 4.96 | 27.9 Years STANDARD_DEVIATION 6.76 | 29.1 Years STANDARD_DEVIATION 5.91 | 29.4 Years STANDARD_DEVIATION 6.84 | 28.5 Years STANDARD_DEVIATION 6.1175 |
| Region of Enrollment United States | 23 Participants | 21 Participants | 22 Participants | 21 Participants | 87 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 7 Participants | 10 Participants | 39 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 15 Participants | 11 Participants | 48 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 | 22 / 22 | 23 / 23 | 20 / 21 | 15 / 21 |
| serious Total, serious adverse events | 1 / 22 | 0 / 23 | 1 / 21 | 1 / 21 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Time frame: Day 15 through Month 10 Post-vaccination 1
Population: Geometric mean titers of the respective vaccine antibodies were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population; per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 15 (N = 19, 21, 14, 18) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 30 (N = 19, 21, 14, 18) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 45 (N = 19, 21, 14, 18) | 124.5 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 60 (N = 19, 21, 14, 18) | 103.7 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 77.5 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 100.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 60 (N = 19, 21, 14, 18) | 492.5 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 15 (N = 19, 21, 14, 18) | 200.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 45 (N = 19, 21, 14, 18) | 887.7 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 30 (N = 19, 21, 14, 18) | 146.4 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 273.2 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 30 (N = 19, 21, 14, 18) | 67.3 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 45 (N = 19, 21, 14, 18) | 148.6 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 60 (N = 19, 21, 14, 18) | 110.4 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 70.7 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 89.9 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 15 (N = 19, 21, 14, 18) | 67.3 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 52.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 30 (N = 19, 21, 14, 18) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 60 (N = 19, 21, 14, 18) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 15 (N = 19, 21, 14, 18) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Day 45 (N = 19, 21, 14, 18) | 54.0 1/dilution (1/dil) |
Primary
Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination
Population: Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Infections and Infestations | 3 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Ear and Labyrinth Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Injury, Poisoning and Procedural Complications | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Neoplasms Benign, Malignant, and Unspecified | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Investigations | 17 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Blood and Lymphatic System Disorders | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Musculoskeletal and Connective Disorders | 6 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Eye Disorders | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Respiratory, Thoracic and Mediastinal Disorders | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Gastrointestinal Disorders | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Cardiac Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | General and Administration Site Disorders | 21 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Psychiatric Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Hepatobiliary Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Immune System Disorders | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Skin and Subcutaneous Tissue Disorders | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Nervous System Disorders | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Hepatobiliary Disorders | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Gastrointestinal Disorders | 7 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Neoplasms Benign, Malignant, and Unspecified | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Blood and Lymphatic System Disorders | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Injury, Poisoning and Procedural Complications | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Ear and Labyrinth Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Psychiatric Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Nervous System Disorders | 12 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Investigations | 19 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | General and Administration Site Disorders | 22 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Musculoskeletal and Connective Disorders | 12 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Cardiac Disorders | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Respiratory, Thoracic and Mediastinal Disorders | 5 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Infections and Infestations | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Eye Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Skin and Subcutaneous Tissue Disorders | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Immune System Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Skin and Subcutaneous Tissue Disorders | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Blood and Lymphatic System Disorders | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Cardiac Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Ear and Labyrinth Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Eye Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Gastrointestinal Disorders | 4 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | General and Administration Site Disorders | 18 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Hepatobiliary Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Immune System Disorders | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Infections and Infestations | 4 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Injury, Poisoning and Procedural Complications | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Investigations | 20 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Musculoskeletal and Connective Disorders | 8 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Neoplasms Benign, Malignant, and Unspecified | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Nervous System Disorders | 6 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Psychiatric Disorders | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Respiratory, Thoracic and Mediastinal Disorders | 8 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Respiratory, Thoracic and Mediastinal Disorders | 5 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Neoplasms Benign, Malignant, and Unspecified | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Immune System Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Hepatobiliary Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Cardiac Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Nervous System Disorders | 3 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | General and Administration Site Disorders | 10 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Gastrointestinal Disorders | 5 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Blood and Lymphatic System Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Psychiatric Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Eye Disorders | 0 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Ear and Labyrinth Disorders | 1 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Investigations | 15 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Skin and Subcutaneous Tissue Disorders | 1 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Musculoskeletal and Connective Disorders | 4 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Injury, Poisoning and Procedural Complications | 1 Participants |
| Saline Placebo | Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. | Infections and Infestations | 4 Participants |
Primary
Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
Time frame: Day 0 through Day 7 post-vaccination
Population: Safety assessments were on participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations - Intent to Treat Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Induration (Post-dose 2) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 2) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 1) | 14 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 1]) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 1) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased Post Dose 2 | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotranferase Increased (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Constipation (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 2) | 12 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Vomiting (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 1) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Rash (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue Post (Post-dose 1) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymph Node Pain (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 2) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 1) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue (Post-dose 2) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 2]) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 1) | 5 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 1) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Rash (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymph Node Pain (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 1]) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 1) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Constipation (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue Post (Post-dose 1) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 1) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 1) | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 1) | 5 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased (Post-dose 1) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 1) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 1) | 18 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 1) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 1) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 2]) | 9 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 2) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue (Post-dose 2) | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 2) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 2) | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 2) | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 2) | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Vomiting (Post-dose 2) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotranferase Increased (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased Post Dose 2 | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 2) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Induration (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 2) | 17 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 2) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 2) | 4 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue Post (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Rash (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotranferase Increased (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 2) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Induration (Post-dose 2) | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased Post Dose 2 | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 2) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 1]) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 2) | 7 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 2]) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 1) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymph Node Pain (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Vomiting (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 2) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 1) | 12 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Constipation (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 2) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 1) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 2) | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 1) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 2) | 2 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 2]) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Swelling (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Fatigue Post (Post-dose 1) | 3 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Induration (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Headache (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Diarrhoea (Post-dose 1) | 2 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 1) | 2 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Myalgia (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Constipation (Post-dose 1) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 2) | 2 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Vomiting (Post-dose 2) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increased (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Chills (Post-dose 1) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotranferase Increased (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Pyrexia (Temperature; [Post-dose 1]) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased Post Dose 2 | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Rash (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased (Post-dose 1) | 4 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 1) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased (Post-dose 2) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Erythema (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nausea (Post-dose 1) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymph Node Pain (Post-dose 1) | 0 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pain (Post-dose 1) | 1 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Injection Site Pruritus (Post-dose 1) | 2 Participants |
| Saline Placebo | Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Malaise (Post-dose 1) | 1 Participants |
Primary
Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Time frame: Day 0 through Day 60 post-vaccination 1
Population: Laboratory parameters were assessed in participants who received the initial injection and had at least one post-baseline immunogenicity assessment, regardless of the time of follow-up or protocol deviations (Intent-to-treat Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Phosphokinase Increased | 6 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Decreased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Red Blood Cells Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increase | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Decreased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Decreased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased | 6 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cells Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Urine Leukocyte Esterase Positive | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Decreased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nitrite Urine Present | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotransferase Increase | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased | 7 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Increased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Eosinophil Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Glucose Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Potassium Increased | 3 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urea Increased | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Protein Urine Present | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Decreased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increase | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Eosinophil Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nitrite Urine Present | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Glucose Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Decreased | 7 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased | 8 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Protein Urine Present | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Decreased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Increased | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Potassium Increased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Decreased | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Increased | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cells Urine | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Phosphokinase Increased | 5 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Decreased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urine | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Urine Leukocyte Esterase Positive | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased | 4 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Decreased | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Red Blood Cells Urine | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Increased | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotransferase Increase | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Increased | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urea Increased | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Urine Leukocyte Esterase Positive | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Potassium Increased | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Protein Urine Present | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increase | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotransferase Increase | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Decreased | 7 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Increased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Increased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Phosphokinase Increased | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Decreased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased | 6 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Decreased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Increased | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urea Increased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urine | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Eosinophil Count Increased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Glucose Urine | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased | 7 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Decreased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Increased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nitrite Urine Present | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Increased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Red Blood Cells Urine | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Decreased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cells Urine | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urine | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Urea Increased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cells Urine | 2 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Decreased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Potassium Increased | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Increased | 3 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Increased | 2 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Platelet Count Increased | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Glucose Decreased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Alanine Aminotranferase Increase | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Red Blood Cells Urine | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Increased | 4 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatinine Decreased | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Phosphokinase Increased | 4 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Urine Leukocyte Esterase Positive | 2 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Creatine Increased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Increased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Protein Urine Present | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | White Blood Cell Count Decreased | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Decreased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Haemoglobin Decreased | 5 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Blood Bilirubin Decreased | 3 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Lymphocyte Count Increased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Glucose Urine | 1 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Eosinophil Count Increased | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Aspartate Aminotransferase Increase | 0 Participants |
| Saline Placebo | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Nitrite Urine Present | 1 Participants |
Primary
Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine
Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 15 through Month 10 Post-vaccination 1
Population: Seroconversion to M2e antigen was assessed participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 45 (N = 19, 20, 14, 18) | 6 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 30 (N = 19, 20, 14, 18) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 4 (N = 19, 20, 13, 18) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 15 (N = 19, 20, 14, 18) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 10 (N = 19, 19, 12, 15) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 60 (N = 19, 20, 14, 18) | 7 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 4 (N = 19, 20, 13, 18) | 16 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 15 (N = 19, 20, 14, 18) | 12 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 30 (N = 19, 20, 14, 18) | 9 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 45 (N = 19, 20, 14, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 60 (N = 19, 20, 14, 18) | 18 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 10 (N = 19, 19, 12, 15) | 8 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 45 (N = 19, 20, 14, 18) | 9 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 15 (N = 19, 20, 14, 18) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 4 (N = 19, 20, 13, 18) | 5 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 30 (N = 19, 20, 14, 18) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 10 (N = 19, 19, 12, 15) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 60 (N = 19, 20, 14, 18) | 6 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 15 (N = 19, 20, 14, 18) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 45 (N = 19, 20, 14, 18) | 1 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 60 (N = 19, 20, 14, 18) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 4 (N = 19, 20, 13, 18) | 1 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Day 30 (N = 19, 20, 14, 18) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine | Month 10 (N = 19, 19, 12, 15) | 0 Participants |
Secondary
Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
Time frame: Day 0 and Day 60 Post-vaccination 1
Population: Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.47 Ratio |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.06 Ratio |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 2.06 Ratio |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.05 Ratio |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.14 Ratio |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 4.28 Ratio |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.07 Ratio |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 2.69 Ratio |
| ACAM FLU A Without Adjuvant | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.50 Ratio |
| ACAM FLU A Without Adjuvant | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.12 Ratio |
| ACAM FLU A Without Adjuvant | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.31 Ratio |
| ACAM FLU A Without Adjuvant | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.32 Ratio |
| Saline Placebo | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.22 Ratio |
| Saline Placebo | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1.0 Ratio |
| Saline Placebo | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 1 Ratio |
| Saline Placebo | Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | GMT Ratio (Day 60/Day 0) | 0.957 Ratio |
Secondary
Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 0 and Day 15 through Month 10 post-vaccination 1
Population: Antibody responses were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 1387 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 311 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 30 (N = 19, 20, 14, 18) | 312 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 45 (N = 19, 20, 14, 18) | 2353 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 (N = 19, 20, 14, 18) | 63.9 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 60 (N = 19, 20, 14, 18) | 2028 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 15 (N = 19, 20, 14, 18) | 367 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 15 (N = 19, 20, 14, 18) | 1779 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 (N = 19, 20, 14, 18) | 53.0 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 60 (N = 19, 20, 14, 18) | 10359 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 30 (N = 19, 20, 14, 18) | 1239 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 45 (N = 19, 20, 14, 18) | 13402 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 7936 1/diultion (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 2110 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 15 (N = 19, 20, 14, 18) | 232 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 244 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 517 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 45 (N = 19, 20, 14, 18) | 794 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 30 (N = 19, 20, 14, 18) | 161 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 (N = 19, 20, 14, 18) | 58.2 1/diultion (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 60 (N = 19, 20, 14, 18) | 637 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 10 (N = 19, 19, 12, 15) | 65.6 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 0 (N = 19, 20, 14, 18) | 66.9 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 15 (N = 19, 20, 14, 18) | 65.8 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 30 (N = 19, 20, 14, 18) | 66.0 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 45 (N = 19, 20, 14, 18) | 68.0 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Day 60 (N = 19, 20, 14, 18) | 64.2 1/diultion (1/dil) |
| Saline Placebo | Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Month 4 (N = 19, 20, 13, 18) | 59.6 1/diultion (1/dil) |
Secondary
Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA). A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).
Time frame: Day 0 and Day 60 Post-vaccination 1
Population: Geometric mean titers (GMTs) and GMT ratios of Anti-M2e antigen were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 53.2 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 73.5 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 52.3 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 56.2 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 54.7 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 113 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 135 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 57.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 233 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 51.8 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 54.4 1/dilution (1/dil) |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 55.5 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 56.3 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 65.8 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 50.0 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 84.3 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 52.6 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 56.2 1/dilution (1/dil) |
| ACAM FLU A Without Adjuvant | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 68.8 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 63.5 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 52.2 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 50.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 52.0 1/dilution (1/dil) |
| Saline Placebo | Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 50.0 1/dilution (1/dil) |
Secondary
Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
Time frame: Day 0 and Day 60 Post-vaccination 1
Population: Seroconversion to M2e antigens were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 5 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 12 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 9 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 2 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 4 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 3 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 2 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 0) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG2 (Day 60) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 60) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG1 (Day 0) | 0 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 0) | 1 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 60) | 3 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG4 (Day 0) | 1 Participants |
| Saline Placebo | Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | IgG3 (Day 60) | 0 Participants |
Secondary
Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response. Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Time frame: Day 0 and Day 15 through Month 10 Post-vaccination 1
Population: Seropositivity to Hepatitis B core antigen was assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 0 (N = 19, 20, 14, 18) | 4 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 15 (N = 19, 20, 14, 18) | 17 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 30 (N = 19, 20, 14, 18) | 17 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 45 (N = 19, 20, 14, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 60 (N = 19, 20, 14, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 4 (N = 19, 20, 13, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 10 (N = 19, 19, 12, 15) | 17 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 0 (N = 19, 20, 14, 18) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 60 (N = 19, 19, 13, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Month 10 (N = 19, 19, 12, 15) | 15 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 30 (N = 19, 20, 14, 18) | 20 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 60 (N = 19, 19, 13, 18) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 45 (N = 19, 20, 14, 18) | 20 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 60 (N = 19, 20, 14, 18) | 20 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 4 (N = 19, 20, 13, 18) | 20 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 10 (N = 19, 19, 12, 15) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Month 10 (N = 19, 19, 12, 15) | 19 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 0 (N = 19, 20, 14, 18) | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 0 (N = 19, 20, 14, 18) | 1 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 15 (N = 19, 20, 14, 18) | 20 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 0 (N = 19, 20, 14, 18) | 0 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 10 (N = 19, 19, 12, 15) | 8 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Month 10 (N = 19, 19, 12, 15) | 9 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 0 (N = 19, 20, 14, 18) | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 45 (N = 19, 20, 14, 18) | 14 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 4 (N = 19, 20, 13, 18) | 12 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 60 (N = 19, 19, 13, 18) | 12 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 15 (N = 19, 20, 14, 18) | 11 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 60 (N = 19, 20, 14, 18) | 14 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 30 (N = 19, 20, 14, 18) | 9 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 60 (N = 19, 20, 14, 18) | 2 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 0 (N = 19, 20, 14, 18) | 0 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 4 (N = 19, 20, 13, 18) | 1 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Month 10 (N = 19, 19, 12, 15) | 0 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Month 10 (N = 19, 19, 12, 15) | 2 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 15 (N = 19, 20, 14, 18) | 3 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 30 (N = 19, 20, 14, 18) | 3 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 45 (N = 19, 20, 14, 18) | 3 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | ELISA Day 0 (N = 19, 20, 14, 18) | 3 Participants |
| Saline Placebo | Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Commercial Kit Day 60 (N = 19, 19, 13, 18) | 0 Participants |
Secondary
Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.
Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
Time frame: Month 4 through Month 10 post-vaccination 1
Population: Influenza signs and symptoms were assessed in participants who had no detectable anti-M2e antibodies on Day 0, received injections on Days 0 and 30, completed the Day 60 visit, and had antibody assessments on Day 60, Per-Protocol Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Culture Confirmed Influenza | 0 Participants |
| ACAM-FLU-A Adjuvanted With Alhydrogel | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Signs and Symptoms of Influenza | 3 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Culture Confirmed Influenza | 0 Participants |
| ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Signs and Symptoms of Influenza | 2 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Signs and Symptoms of Influenza | 1 Participants |
| ACAM FLU A Without Adjuvant | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Culture Confirmed Influenza | 0 Participants |
| Saline Placebo | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Signs and Symptoms of Influenza | 0 Participants |
| Saline Placebo | Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | Culture Confirmed Influenza | 0 Participants |