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| ID | Type | Description | Link |
|---|---|---|---|
| 2U19AI057229-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is an exploratory study using a strategy that has not been previously employed to investigate the effects of age and vaccine type on specific kinds of immune responses to licensed, seasonal 2009-2010 influenza vaccines in children and adults.
This study is being conducted in healthy male and female volunteers. 8-17 year-old identical twins will be randomly assigned to receive a single administration of the 2009-2010 formulation of either seasonal trivalent inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV). Twins within a pair will receive different vaccines. 18-30 year-old and 70-100 year-old subjects will receive a single administration of the 2009-2010 formulation of TIV. Blood samples to conduct the assays will be taken at pre-immunization, Day 7-8 and Day 28 post immunization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 8-17 years (identical twins ) | Experimental | Participants will be randomized to receive either Fluzone® 2009-2010 Formula or FluMist® 2009-2010 Formula |
|
| Age 18-30 years (non-twins) | Experimental | Participants will be receive Fluzone® 2009-2010 Formula |
|
| Age >70 years (non-twins) | Experimental | Participants will receive Fluzone® 2009-2010 Formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® 2009-2010 Formula | Biological | This vaccine is given intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Day 0 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | Day 0 to 28 post-immunization |
| Measure | Description | Time Frame |
|---|---|---|
| To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine | Day 0 to 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L Dekker, MD | Stanford University | Principal Investigator |
| Harry B Greenberg, MD | Stanford University | Principal Investigator |
| Xiaosong He, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford LPCH Vaccine Program | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21182843 | Background | He XS, Sasaki S, Narvaez CF, Zhang C, Liu H, Woo JC, Kemble GW, Dekker CL, Davis MM, Greenberg HB. Plasmablast-derived polyclonal antibody response after influenza vaccination. J Immunol Methods. 2011 Feb 28;365(1-2):67-75. doi: 10.1016/j.jim.2010.12.008. Epub 2010 Dec 21. | |
| 21785218 | Background | Sasaki S, Sullivan M, Narvaez CF, Holmes TH, Furman D, Zheng NY, Nishtala M, Wrammert J, Smith K, James JA, Dekker CL, Davis MM, Wilson PC, Greenberg HB, He XS. Limited efficacy of inactivated influenza vaccine in elderly individuals is associated with decreased production of vaccine-specific antibodies. J Clin Invest. 2011 Aug;121(8):3109-19. doi: 10.1172/JCI57834. Epub 2011 Jul 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Age 8-17 Years (Identical Twins ) | Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly Flumist® 2009-2010 Formula: This vaccine is given intranasally |
| FG001 | Age 18-30 Years (Non-twins) | Participants will be receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly |
| FG002 | Age > 70 Years (Non-twins) | Participants will receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age 8-17 Years (Identical Twins ) | Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly Flumist® 2009-2010 Formula: This vaccine is given intranasally |
| BG001 | Age 18-30 Years (Non-twins) |
| 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 From Each Arm Who Received Influenza Vaccine | Posted | Count of Participants | Participants | Day 0 to 28 |
|
Day 0 to Day 28 of study participation
Clinical Assessment performed at each visit
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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 | Age 8-17 Years (Identical Twins ) | Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly Flumist® 2009-2010 Formula: This vaccine is given intranasally |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cornelia Dekker | Stanford University School of Medicine, Dept. of Pediatrics | 650-724-4437 | cdekker@stanford.edu |
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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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| FluMist® 2009-2010 Formula | Biological | This vaccine is given intranasally |
|
|
| 23107783 | Background | He XS, Sasaki S, Baer J, Khurana S, Golding H, Treanor JJ, Topham DJ, Sangster MY, Jin H, Dekker CL, Subbarao K, Greenberg HB. Heterovariant cross-reactive B-cell responses induced by the 2009 pandemic influenza virus A subtype H1N1 vaccine. J Infect Dis. 2013 Jan 15;207(2):288-96. doi: 10.1093/infdis/jis664. Epub 2012 Oct 29. |
| 23390249 | Background | Jiang N, He J, Weinstein JA, Penland L, Sasaki S, He XS, Dekker CL, Zheng NY, Huang M, Sullivan M, Wilson PC, Greenberg HB, Davis MM, Fisher DS, Quake SR. Lineage structure of the human antibody repertoire in response to influenza vaccination. Sci Transl Med. 2013 Feb 6;5(171):171ra19. doi: 10.1126/scitranslmed.3004794. |
| 25594173 | Background | Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020. |
| 28963118 | Derived | de Bourcy CFA, Dekker CL, Davis MM, Nicolls MR, Quake SR. Dynamics of the human antibody repertoire after B cell depletion in systemic sclerosis. Sci Immunol. 2017 Sep 29;2(15):eaan8289. doi: 10.1126/sciimmunol.aan8289. |
Participants will be receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly |
| BG002 | Age > 70 Years (Non-twins) | Participants will receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly |
|
|
| Secondary | Number of Participants With Related Adverse Events | Posted | Count of Participants | Participants | Day 0 to 28 post-immunization |
|
|
|
| Other Pre-specified | To Investigate the Effects of Age and Vaccine Type on B-cell Responses to Influenza Vaccine | Not Posted | Day 0 to 28 | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Age 18-30 Years (Non-twins) | Participants will be receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly | 0 | 24 | 0 | 24 |
| EG002 | Age > 70 Years (Non-twins) | Participants will receive Fluzone® 2009-2010 Formula Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly | 0 | 21 | 0 | 21 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |