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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | ACAM-FLU-A low dose + Adjuvant 1 |
|
| Study Group 2 | Experimental | ACAM-FLU-A low dose + Adjuvant 2 |
|
| Study Group 3 | Experimental | ACAM-FLU-A low dose |
|
| Study Group 4 | Placebo Comparator | Saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza A Vaccine: ACAM FLU-A | Biological | 0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 0 through Day 7 post-vaccination |
| 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 | Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA) | Day 15 through Month 10 Post-vaccination 1 |
| 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) | Day 15 through Month 10 Post-vaccination 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Johnson County Clin-Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23527091 | Derived | Ibanez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18. |
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A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Saline Placebo | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | ACAM-FLU-A Adjuvanted With Stimulon® QS-21 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Participants | Day 0 through Day 60 post-vaccination |
|
Adverse events data were collected from the day of vaccination (Day 0) up to 9 months post-vaccination 1
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 10.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Influenza A Vaccine: ACAM FLU-A | Biological | 0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular |
|
|
| Influenza A Vaccine: ACAM FLU-A | Biological | 0.5 mL ACAM FLU-A low dose, Intramuscular |
|
|
| Saline placebo | Biological | 0.5 mL, Intramuscular |
|
|
| Month 4 through Month 10 post-vaccination 1 |
| 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) | Day 0 and Day 60 Post-vaccination 1 |
| 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). | Day 0 and Day 60 Post-vaccination 1 |
| 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). | Day 0 and Day 60 Post-vaccination 1 |
| 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) | Day 0 and Day 15 through Month 10 post-vaccination 1 |
| 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 | Day 0 and Day 15 through Month 10 Post-vaccination 1 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Northwest Kinetics | Tacoma | Washington | 98418 | United States |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Death |
|
Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
| BG002 | 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. |
| BG003 | Saline Placebo | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG002 | 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. |
| OG003 | Saline Placebo | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. |
|
|
| 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. | 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. | Posted | Number | Participants | Day 0 through Day 7 post-vaccination |
|
|
|
| Primary | Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. | 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). | Posted | Number | Participants | Day 0 through Day 60 post-vaccination 1 |
|
|
|
| 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. | 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. | Posted | Number | Participants | Month 4 through Month 10 post-vaccination 1 |
|
|
|
| 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) | 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. | Posted | Number | Participants | Day 15 through Month 10 Post-vaccination 1 |
|
|
|
| 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) | 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. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution (1/dil) | Day 15 through Month 10 Post-vaccination 1 |
|
|
|
| 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) | 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. | Posted | Number | Participants | Day 0 and Day 60 Post-vaccination 1 |
|
|
|
| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | 1/dilution (1/dil) | Day 0 and Day 60 Post-vaccination 1 |
|
|
|
| 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). | 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. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 0 and Day 60 Post-vaccination 1 |
|
|
|
| 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) | 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. | Posted | Geometric Mean | 95% Confidence Interval | 1/diultion (1/dil) | Day 0 and Day 15 through Month 10 post-vaccination 1 |
|
|
|
| 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 | 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. | Posted | Number | Participants | Day 0 and Day 15 through Month 10 Post-vaccination 1 |
|
|
|
| 1 |
| 22 |
| 22 |
| 22 |
| EG001 | 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. | 0 | 23 | 23 | 23 |
| EG002 | 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. | 1 | 21 | 20 | 21 |
| EG003 | Saline Placebo | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. | 1 | 21 | 15 | 21 |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Alanine aminotransferase increase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Aspartate aminotransferase increase | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 10.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Syncope vasovagal | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Pyrexia (Temperature; [Post-dose 1]) |
|
| Chills (Post-dose 1) |
|
| Constipation (Post-dose 1) |
|
| Diarrhoea (Post-dose 1) |
|
| Fatigue Post (Post-dose 1) |
|
| Headache (Post-dose 1) |
|
| Malaise (Post-dose 1) |
|
| Myalgia (Post-dose 1) |
|
| Nausea (Post-dose 1) |
|
| Alanine Aminotranferase Increased (Post-dose 1) |
|
| Blood Creatinine Increased (Post-dose 1) |
|
| Haemoglobin Decreased (Post-dose 1) |
|
| Platelet Count Decreased (Post-dose 1) |
|
| White Blood Cell Count Increased (Post-dose 1) |
|
| Injection Site Erythema (Post-dose 1) |
|
| Injection Site Pain (Post-dose 1) |
|
| Injection Site Pruritus (Post-dose 1) |
|
| Injection Site Swelling (Post-dose 1) |
|
| Pyrexia (Temperature; [Post-dose 2]) |
|
| Chills (Post-dose 2) |
|
| Diarrhoea (Post-dose 2) |
|
| Fatigue (Post-dose 2) |
|
| Headache (Post-dose 2) |
|
| Malaise (Post-dose 2) |
|
| Myalgia (Post-dose 2) |
|
| Nausea (Post-dose 2) |
|
| Vomiting (Post-dose 2) |
|
| Alanine Aminotranferase Increased (Post-dose 2) |
|
| Aspartate Aminotranferase Increased (Post-dose 2) |
|
| Haemoglobin Decreased (Post-dose 2) |
|
| Platelet Count Decreased Post Dose 2 |
|
| White Blood Cell Count Increased (Post-dose 2) |
|
| Injection Site Erythema (Post-dose 2) |
|
| Injection Site Induration (Post-dose 2) |
|
| Injection Site Pain (Post-dose 2) |
|
| Injection Site Pruritus (Post-dose 2) |
|
| Injection Site Swelling (Post-dose 2) |
|
| Injection Site Rash (Post-dose 2) |
|
| Aspartate Aminotransferase Increase |
|
| Blood Bilirubin Decreased |
|
| Blood Bilirubin Increased |
|
| Blood Creatine Increased |
|
| Blood Creatine Phosphokinase Increased |
|
| Blood Creatinine Decreased |
|
| Blood Creatinine Increased |
|
| Blood Glucose Decreased |
|
| Blood Glucose Increased |
|
| Blood Potassium Increased |
|
| Blood Urea Increased |
|
| Blood Urine |
|
| Eosinophil Count Increased |
|
| Glucose Urine |
|
| Haemoglobin Decreased |
|
| Lymphocyte Count Decreased |
|
| Lymphocyte Count Increased |
|
| Nitrite Urine Present |
|
| Platelet Count Decreased |
|
| Platelet Count Increased |
|
| Protein Urine Present |
|
| Red Blood Cells Urine |
|
| Urine Leukocyte Esterase Positive |
|
| White Blood Cell Count Decreased |
|
| White Blood Cell Count Increased |
|
| White Blood Cells Urine |
|
| Culture Confirmed Influenza |
|
| Day 30 (N = 19, 20, 14, 18) |
|
| Day 45 (N = 19, 20, 14, 18) |
|
| Day 60 (N = 19, 20, 14, 18) |
|
| Month 4 (N = 19, 20, 13, 18) |
|
| Month 10 (N = 19, 19, 12, 15) |
|
| Day 30 (N = 19, 21, 14, 18) |
|
| Day 45 (N = 19, 21, 14, 18) |
|
| Day 60 (N = 19, 21, 14, 18) |
|
| Month 4 (N = 19, 20, 13, 18) |
|
| Month 10 (N = 19, 19, 12, 15) |
|
| IgG1 (Day 60) |
|
| IgG2 (Day 0) |
|
| IgG2 (Day 60) |
|
| IgG3 (Day 0) |
|
| IgG3 (Day 60) |
|
| IgG4 (Day 0) |
|
| IgG4 (Day 60) |
|
| IgG1 (Day 60) |
|
| IgG2 (Day 0) |
|
| IgG2 (Day 60) |
|
| IgG3 (Day 0) |
|
| IgG3 (Day 60) |
|
| IgG4 (Day 0) |
|
| IgG4 (Day 60) |
|
| GMT Ratio (Day 60/Day 0) |
|
| GMT Ratio (Day 60/Day 0) |
|
| GMT Ratio (Day 60/Day 0) |
|
| Day 15 (N = 19, 20, 14, 18) |
|
| Day 30 (N = 19, 20, 14, 18) |
|
| Day 45 (N = 19, 20, 14, 18) |
|
| Day 60 (N = 19, 20, 14, 18) |
|
| Month 4 (N = 19, 20, 13, 18) |
|
| Month 10 (N = 19, 19, 12, 15) |
|
| ELISA Day 15 (N = 19, 20, 14, 18) |
|
| ELISA Day 30 (N = 19, 20, 14, 18) |
|
| ELISA Day 45 (N = 19, 20, 14, 18) |
|
| ELISA Day 60 (N = 19, 20, 14, 18) |
|
| ELISA Month 4 (N = 19, 20, 13, 18) |
|
| ELISA Month 10 (N = 19, 19, 12, 15) |
|
| Commercial Kit Day 0 (N = 19, 20, 14, 18) |
|
| Commercial Kit Day 60 (N = 19, 19, 13, 18) |
|
| Commercial Kit Month 10 (N = 19, 19, 12, 15) |
|