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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-4713 |
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The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.
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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| 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 | Biological | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months | Pre- 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 6 to 35 Months | Seroprotection: Antibody titer of ≥ 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 6 to 35 Months | 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 Vaccine) Strain - Age 3 to 9 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 3 to 9 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 3 to 9 Years |
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Inclusion Criteria :
All subjects:
Subjects aged 3 to 9 years:
Subjects aged 6 to 35 months:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Beach | Florida | 33141 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21219979 | Result | Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8. | |
| 20018365 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 474 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.
Participants were enrolled from 06 August 2009 to 13 August 2009 at 19 US clinical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | A/H1N1 Vaccine Group 1 | Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. |
| FG001 | A/H1N1 Vaccine Group 2 | Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Monovalent Subvirion A/H1N1 Influenza vaccine | Biological | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months) |
|
| Normal saline solution (placebo) | Biological | 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months) |
|
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 At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability. | Days 0 to 7 post-vaccination |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months | 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. | Days 0 to 7 post-vaccination |
| Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 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. | Days 0 to 7 post vaccination |
| Marietta |
| Georgia |
| 30062 |
| United States |
| Woodstock | Georgia | 30189 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Louisville | Kentucky | 40291 | United States |
| Maddisonville | Kentucky | 42431 | United States |
| Metairie | Louisiana | 70006 | United States |
| Las Vegas | Nevada | 89104 | United States |
| Rochester | New York | 14609 | United States |
| Hermitage | Pennsylvania | 16148 | United States |
| Pittsburgh | Pennsylvania | 15237 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Cranston | Rhode Island | O2920 | United States |
| Barnwell | South Carolina | 29812 | United States |
| Austin | Texas | 78705 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Angelo | Texas | 76904 | United States |
| Orem | Utah | 84057 | United States |
| South Jordan | Utah | 84095 | United States |
| Springville | Utah | 84663 | United States |
| 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. |
| FG002 | 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 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. |
| BG001 | A/H1N1 Vaccine Group 2 | Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. |
| BG002 | Placebo Group | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
| BG003 | 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 6 to 35 Months | Pre- 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 6 to 35 Months | Seroprotection: Antibody titer of ≥ 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 6 to 35 Months | 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 Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 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 3 to 9 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 Day 21 post-vaccination |
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| Primary | Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 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 Day 21 post-vaccination |
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| Primary | Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months | Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability. | 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 Following Vaccination - Age 24 to 35 Months | 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. | 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 Following Vaccination - Age 3 to 9 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. | 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.
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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 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. | 1 | 219 | 110 | 219 | ||
| EG001 | A/H1N1 Vaccine Group 2 | Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively. | 0 | 204 | 104 | 204 | ||
| EG002 | Placebo Group | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | 1 | 51 | 27 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Furuncle | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injectiuon site tenderness | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Injection site ecchymosis | General disorders | MedDRA 12.0 | Systematic Assessment |
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| Pyrexia (Fever) | 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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| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Crying abnormal | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
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| Drowsiness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
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| Appetite lost | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
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| Irritability | Psychiatric 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 2 (Day 42) Titers at ≥ 10 1/dil |
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