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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.75_(50)MF59 | Experimental | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
|
| 7.5_(0)MF59 | Experimental | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
| 7.5_(50)MF59 | Experimental | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
|
| 15_(0)MF59 | Experimental | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF59-eH1N1_f | Biological | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Responses After the First and Second Vaccinations | CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. | 21 days after each vaccination |
| Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. | Day 1 to 7 |
| Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. | Day 22 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Measurement by Geometric Mean Titers (GMT) | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. | 21 days after each vaccination |
| Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 |
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Inclusion Criteria:
Exclusion Criteria:
For additional entry criteria, please refer to protocol
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines and Diagnostics | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bentonville | Arkansas | 72712 | United States | |||
All subjects enrolled were included in the trial. The data entered is for the overall study.
Participants were enrolled at 29 sites in USA and Mexico. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3.75_(50)MF59 | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| FG001 | 7.5_(0)MF59 | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| MF59-eH1N1_f | Biological | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
| MF59-eH1N1_f | Biological | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
| MF59-eH1N1_f | Biological | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
|
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. |
| Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| Antibody Response Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10). | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| Antibody Persistence by Geometric Mean Titers (GMT) | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. | 6 months (Day 202) and 12 months (Day 387) after second vaccination |
| Fort Smith |
| Arkansas |
| 72903 |
| United States |
| Canoga Park | California | 91306 | United States |
| Dinuba | California | 93618 | United States |
| Fresno | California | 93703 | United States |
| Long Beach | California | 90806 | United States |
| Los Angeles | California | 90015 | United States |
| Madera | California | 93637 | United States |
| Torrance | California | 90503 | United States |
| New Albany | Indiana | 47150 | United States |
| Newton | Kansas | 67114 | United States |
| Wichita | Kansas | 67207 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Fargo | North Dakota | 58104 | United States |
| Dayton | Ohio | 45406 | United States |
| Huber Heights | Ohio | 45424 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Charleston | South Carolina | 29406 | United States |
| Spartanburg | South Carolina | 29303 | United States |
| Lebanon | Tennessee | 37087 | United States |
| Dallas | Texas | 75230 | United States |
| Houston | Texas | 77055 | United States |
| Provo | Utah | 84604 | United States |
| South Jordan | Utah | 84095 | United States |
| St. George | Utah | 84790 | United States |
| West Jordan | Utah | 84088 | United States |
| Charlottesville | Virginia | 22902 | United States |
| Tlalpan | Mexico City | 14000 | Mexico |
| FG002 | 7.5_(50)MF59 | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| FG003 | 15_(0)MF59 | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3.75_(50)MF59 | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| BG001 | 7.5_(0)MF59 | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| BG002 | 7.5_(50)MF59 | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| BG003 | 15_(0)MF59 | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| BG004 | 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, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Antibody Responses After the First and Second Vaccinations | CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. | The analysis was done on the per-protocol set (PPS). | Posted | Number | 95% Confidence Interval | Percentages of Subjects | 21 days after each vaccination |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity Measurement by Geometric Mean Titers (GMT) | Immunogenicity was measured in terms of the GMT at 21 days after each vaccination. | The analysis was done on the Full Analysis Set (FAS). | Posted | Geometric Mean | 95% Confidence Interval | Titers | 21 days after each vaccination |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination. | The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS. | Posted | Number | Participants | Day 1 to 7 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination | Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination. | The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination. | Posted | Number | Participants | Day 22 to 28 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | The analysis was done on the subgroup of the per-protocol set(PPS). | Posted | Number | 95% Confidence Interval | Percentages of Subjects | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 | Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines. | The analysis was done on the subgroup on the per-protocol set (PPS). | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Response Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 | The analysis was done on the subgroup of the per-protocol set (PPS). | Posted | Number | 95% Confidence Interval | Percentages of Subjects | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMTs) Based on Baseline Seropositivity | Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10). | The analysis was done on the subgroup of the per-protocol set (PPS). | Posted | Geometric Mean | 95% Confidence Interval | Titres | Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Antibody Persistence by Geometric Mean Titers (GMT) | Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination. | The analysis was done on the subgroup of the per-protocol set (PPS). | Posted | Geometric Mean | 95% Confidence Interval | Titer | 6 months (Day 202) and 12 months (Day 387) after second vaccination |
|
Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.
Local, systemic, and other reactions were collected from Study days 1 to 7 and 22 to 28. SAEs, medically attended visits, new onset of chronic diseases and AEs that lead to subject's withdrawal were collected from Day 1 (post-consent) through Day 387 (12 months following second 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 | 3.75_(50)MF59 | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 5 | 162 | 144 | 162 | ||
| EG001 | 7.5_(0)MF59 | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 6 | 164 | 152 | 164 | ||
| EG002 | 7.5_(50)MF59 | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. | 1 | 162 | 141 | 162 | ||
| EG003 | 15_(0)MF59 | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. | 10 | 166 | 142 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intussusception | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Abdominal abcess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Genital abscess | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Croup infections | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| Injection site pain | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
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| Male |
|
| HI titer ≥1:40 (Day 22) |
|
| Seroconversion Day 22 |
|
| HI titer ≥1:40 (Day 43) |
|
| Seroconversion Day 43 |
|
| HI titer ≥1:40 (Day 202;N=45,38,46,38) |
|
| Seroconversion Day 202;N=45,38,46,38) |
|
| HI titer ≥1:40 (Day 387;N=46,37,38,36) |
|
| Seroconversion Day 387;N=45,38,46,38) |
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
|
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
| OG004 | 3.75_(50)MF59-Previous Vaccination | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG005 | 7.5_(0)MF59-Previous Vaccination | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| OG006 | 7.5_(50) MF59-Previous Vaccinaiton | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG007 | 15_(0)MF59-Previous Vaccination | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
|
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
| OG004 | 3.75_(50)MF59-Previous Vaccination | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG005 | 7.5_(0)MF59-Previous Vaccination | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| OG006 | 7.5_(50) MF59-Previous Vaccinaiton | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG007 | 15_(0)MF59-with Previous Vaccination | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
|
| OG004 | 3.75_(50)MF59 - Baseline HI ≥1:10 | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG005 | 7.5_(0)MF59 - Baseline HI ≥1:10 | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| OG006 | 7.5_(50)MF59 - Baseline HI ≥1:10 | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG007 | 15_(0)MF59 - Baseline HI ≥1:10 | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
|
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| OG004 | 3.75_(50)MF59 - Baseline HI ≥1:10 | 3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG005 | 7.5_(0)MF59 - Baseline HI ≥1:10 | 7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
| OG006 | 7.5_(50)MF59 - Baseline HI ≥1:10 | 7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. |
| OG007 | 15_(0)MF59 - Baseline HI ≥1:10 | 15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|