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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-4882 |
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The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.
Primary Objectives:
Participants will receive a single injection of their randomized vaccine on Day 0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant) |
|
| A/H1N1 Vaccine Group 2 | Experimental | Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant) |
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| A/H1N1 Vaccine Group 3 | Active Comparator | Participants will receive A/H1N1 vaccine formulation 3 |
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| A/H1N1 Vaccine Group 4 | Active Comparator | Participants will receive A/H1N1 vaccine formulation 4 |
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| Placebo Group 5 | Placebo Comparator | Participants will receive a placebo vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant | Biological | 0.5 mL, Intramuscular on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination. | Day 0 and Day 21 post-vaccination |
| Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). | Day 0 and Day 21 post-vaccination |
| Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. | Day 0 and Day 21 post-vaccination |
| Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil). | Day 0 and Day 21 post-vaccination |
| Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
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| Label | URL |
|---|---|
| Related Info | View source |
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A total of 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants were enrolled from 29 October 2009 to 13 November 2009 at 14 US clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 |
| FG001 | Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant | Biological | 0.5 mL, Intramuscular on Day 0 |
|
| Monovalent Subvirion A/H1N1 influenza vaccine | Biological | 0.5 mL, Intramuscular on Day 0 |
|
| Monovalent Subvirion A/H1N1 influenza vaccine | Biological | 0.5 mL, Intramuscular on Day 0 |
|
| Normal saline solution | Biological | 0.5 mL, Intramuscular on Day 0 |
|
| Day 0 and Day 21 post-vaccination |
| Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. | Day 0 and Day 21 post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering | Day 0 up to Day 7 post-vaccination |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. | Day 0 up to Day 7 post-vaccination |
| Fountain Valley |
| California |
| 92708 |
| United States |
| South Miami | Florida | 33143 | United States |
| Springfield | Missouri | 65802 | United States |
| Rochester | New York | 14609 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cleveland | Ohio | 44122 | United States |
| Grove City | Pennsylvania | 16127 | United States |
| Jefferson Hills | Pennsylvania | 15025 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Jackson | Tennessee | 38305 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Springville | Utah | 84663 | United States |
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
| FG002 | Group 3: A/H1N1 Vaccine Formulation 3 | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 |
| FG003 | Group 4: A/H1N1 Vaccine Formulation 4 | Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| FG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 |
| BG001 | Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 |
| BG002 | Group 3: A/H1N1 Vaccine Formulation 3 | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 |
| BG003 | Group 4: A/H1N1 Vaccine Formulation 4 | Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| BG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
| BG005 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | Participants |
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| 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 With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination. | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years. | Posted | Number | Participants | Day 0 and Day 21 post-vaccination |
|
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| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years. | Posted | Number | Participants | Day 0 and Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 21 post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil). | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older. | Posted | Number | Participants | Day 0 and Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil). | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older. | Posted | Number | Participants | Day 0 and Day 21 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. | Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 and Day 21 post-vaccination |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent to treat population aged 18 to 64 years. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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| Primary | Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years | Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population aged 65 years or older. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
|
Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.
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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 | Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0 | 6 | 127 | 77 | 127 | ||
| EG001 | Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant | Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0 | 5 | 115 | 75 | 115 | ||
| EG002 | Group 3: A/H1N1 Vaccine Formulation 3 | Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0 | 5 | 122 | 75 | 122 | ||
| EG003 | Group 4: A/H1N1 Vaccine Formulation 4 | Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 | 4 | 121 | 82 | 121 | ||
| EG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 | 5 | 63 | 40 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 12.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Day 21 (Post-vaccination) |
|
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
| Group 4: A/H1N1 Vaccine Formulation 4 |
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|
| Group 4: A/H1N1 Vaccine Formulation 4 |
Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0 |
| OG004 | Group 5: Placebo | Participants who received a dose of placebo (normal saline) on Day 0 |
|
|