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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-4798 | Other Identifier | WHO |
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The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine.
Primary Objectives:
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | Participants will receive A/H1N1 vaccine formulation 1 |
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| A/H1N1 Vaccine Group 2 | Experimental | Participants will receive A/H1N1 vaccine formulation 2 |
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| A/H1N1 Vaccine Group 3 | Experimental | Participants will receive A/H1N1 Vaccine formulation 3 |
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| Placebo Group | 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 (7.5 µg of HA) | Biological | 0.5 mL, Intramuscular on Day 0 and on Day 21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre-vaccination (Day 0) and day 21 post-vaccination |
| Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre-vaccination (Day 0) and Day 21 post-vaccination |
| Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre-vaccination (Day 0) and 21 days post-vaccination |
| Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre-vaccination (Day 0) and 21 days post-vaccination |
| Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre-vaccination (Day 0) and 21 days post-vaccination |
| Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years |
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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 |
|---|---|---|---|---|---|---|
| Hoover | Alabama | 35216 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20018365 | Result | Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | A/H1N1 Vaccine Group 1 | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. |
| FG001 | A/H1N1 Vaccine Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) | Biological | 0.5 mL, Intramuscular on Day 0 and Day 21 |
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| Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) | Biological | 0.5 mL, Intramuscular on Day 0 and day 21 |
|
| Normal saline solution (placebo) | Biological | 0.5 mL, Intramuscular on Day 0 and Day 21 |
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. |
| Pre-vaccination (Day 0) and 21 days post-vaccination |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). | Days 0 to 7 post-vaccination |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). | Days 0 to 7 post-vaccination |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Phoenix | Arizona | 85020 | United States |
| Anaheim | California | United States |
| South Miami | Florida | 33143 | United States |
| Maddisonville | Kentucky | 42431 | United States |
| Springfield | Missouri | 65802 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Cincinnati | Ohio | 45227 | United States |
| Cleveland | Ohio | 44122 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Knoxville | Tennessee | 37920 | United States |
| Austin | Texas | 78705 | United States |
| Salt Lake City | Utah | 84124 | United States |
| Norfolk | Virginia | 23507 | United States |
Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
| FG002 | A/H1N1 Vaccine Group 3 | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. |
| FG003 | Placebo Group | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A/H1N1 Vaccine Group 1 | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. |
| BG001 | A/H1N1 Vaccine Group 2 | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. |
| BG002 | A/H1N1 Vaccine Group 3 | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. |
| BG003 | Placebo Group | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre- and post-vaccination antibody titers were assessed in the per-protocol population. | Posted | Number | Participants | Pre-vaccination (Day 0) and day 21 post-vaccination |
|
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| Primary | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. | Antibody titers were assessed in the per-protocol population. | Posted | Number | Participants | Pre-vaccination (Day 0) and Day 21 post-vaccination |
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| Primary | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Antibody titers were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Pre-vaccination (Day 0) and 21 days post-vaccination |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre- and post-vaccination antibody titers were assessed in the per-protocol population. | Posted | Number | Participants | Pre-vaccination (Day 0) and 21 days post-vaccination |
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| Primary | Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test. | Pre- and post-vaccination antibody titers were assessed in the per-protocol population. | Posted | Number | Participants | Pre-vaccination (Day 0) and 21 days post-vaccination |
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| Primary | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years | Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test. | Antibody titers were assessed in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Pre-vaccination (Day 0) and 21 days post-vaccination |
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| Primary | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Participants | Days 0 to 7 post-vaccination |
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| Primary | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years | Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills). | Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. | Posted | Number | Participants | Days 0 to 7 post-vaccination |
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Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2.
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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 | A/H1N1 Vaccine Group 1 | Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | 8 | 248 | 82 | 248 | ||
| EG001 | A/H1N1 Vaccine Group 2 | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | 7 | 254 | 78 | 254 | ||
| EG002 | A/H1N1 Vaccine Group 3 | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | 7 | 248 | 96 | 248 | ||
| EG003 | Placebo Group | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | 4 | 99 | 30 | 99 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | 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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| Femoral hernia | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Lung neoplasm malignan | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Non-Hodgkins lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Non-systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Global amnesia | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Myasthenia gravis | Nervous system disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Aortic aneurysm | Vascular disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 12.0 | 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Post-Vaccination 1 (Day 21) Titers at ≥ 10 |
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| Post-Vaccination 2 (Day 42) Titers at ≥ 10 |
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Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
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Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
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