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| ID | Type | Description | Link |
|---|---|---|---|
| 1U19AI090019-01 | 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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The purpose of this study is to investigate the responses to licensed trivalent, inactivated influenza vaccine (TIV) delivered by different routes: intramuscular (IM) and intradermal (ID) and to the live, attenuated influenza vaccine (LAIV) administered intranasally -- all given to generally healthy male and female adult volunteers.
The aim of this study is to compare the response to different formulations of licensed influenza vaccines.
The type of seasonal influenza vaccination(s) received independently by volunteers in the year(s) since their last study visit will not impact eligibility. Volunteers will be assigned into one of three vaccine groups (intramuscular trivalent inactivated influenza vaccine (TIV); live attenuated influenza vaccine (LAIV- given year 1 only) or intradermal TIV, based on the type of study vaccine they received in 2010, 2011, 2012, or 2013. All participants will receive a single dose of their assigned seasonal influenza vaccine. Volunteers will complete 3 study visits at Day 0, Day 6-8 and Day 24-32.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A Fluzone® (IM) | Experimental | Participants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone®, administered intramuscularly (IM) 2011-2012, 2012-2013 or 2013-2014 Fluzone was used as appropriate for the current year of study |
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| Group B Fluzone® Intradermal (ID) | Experimental | Participants in this group will be randomized to the trivalent inactivated influenza vaccine (TIV), Fluzone® Intradermal, administered intradermally (ID) 2011-2012, 2012-2013 or 2013-2014 Fluzone Intradermal was used as appropriate for the current year of study |
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| Group C 2011-2012 FluMist® | Experimental | Participants in this group will be randomized to 2011-2012 live attenuated influenza vaccine, FluMist®, administered intranasally. FluMist was only used in the first year of study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone® (IM) | Biological | This vaccine is given intramuscularly (IM) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants From Each Arm Who Received Influenza Vaccine | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Adverse Events | Number of participants with Related Adverse Events with a 0% Frequency Threshold | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination | Baseline to Day 7 |
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 |
|---|---|---|---|
| 23898164 | Background | Vollmers C, Sit RV, Weinstein JA, Dekker CL, Quake SR. Genetic measurement of memory B-cell recall using antibody repertoire sequencing. Proc Natl Acad Sci U S A. 2013 Aug 13;110(33):13463-8. doi: 10.1073/pnas.1312146110. Epub 2013 Jul 29. | |
| 25336731 | Background | He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21. |
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The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique ID code and the volunteer identity (except for age) will not be disclosed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A Fluzone® (IM) | Participants in this group will be randomized to Fluzone® administered intramuscularly (IM) |
| FG001 | Group B Fluzone® (ID) | Participants in this group will be randomized to Fluzone® administered intradermally (ID) |
| FG002 | Group C FluMist® | Participants in this group will be randomized to FluMist® administered intranasally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A Fluzone® (IM) | Participants in this group will be randomized to Fluzone® administered intramuscularly (IM) |
| BG001 | Group B Fluzone® (ID) | Participants in this group will be randomized to Fluzone® administered intradermally (ID) |
| 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, Customized | 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 | Baseline to Day 28 |
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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 A Fluzone® (IM) | Participants in this group will be randomized to Fluzone® administered intramuscularly (IM) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Panic Attack | Psychiatric disorders | Systematic Assessment | Panic attack associated with Bipolar disorder resulting in prolonged hospitalization. Episode not related to vaccination or participation in study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Associated with vaccine injection. Chest tightness and cough after injection, relieved by inhaler, without sequelae. |
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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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| Fluzone® Intradermal (ID) | Biological | This vaccine is given intradermally (ID) |
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| 2011-2012 FluMist® | Biological | This vaccine is given intranasally |
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| 27655870 | Background | Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21. |
| BG002 | Group C FluMist® | Participants in this group will be randomized to FluMist® administered intranasally. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Participants With Related Adverse Events | Number of participants with Related Adverse Events with a 0% Frequency Threshold | Posted | Count of Participants | Participants | Baseline to Day 28 |
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| Other Pre-specified | Frequency of Vaccine-specific Antibody Secreting Cells on Day 5 and Day 7 After Vaccination | Not Posted | Baseline to Day 7 | Participants |
| 0 |
| 42 |
| 1 |
| 42 |
| 3 |
| 42 |
| EG001 | Group B Fluzone® (ID) | Participants in this group will be randomized to Fluzone® administered intradermally (ID) | 0 | 19 | 0 | 19 | 3 | 19 |
| EG002 | Group C FluMist® | Participants in this group will be randomized to FluMist® administered intranasally. | 0 | 25 | 1 | 25 | 2 | 25 |
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| Depression | Psychiatric disorders | Systematic Assessment | Depression leading to hospitalization, not associated with vaccine injection or study participation. |
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| Erythema at injection site | General disorders | Systematic Assessment | Associated with vaccine injection. Erythema resolved without sequelae. |
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| Presyncope | Nervous system disorders | Systematic Assessment | Not associated with vaccine injection. Associated with blood draw. All subjects recovered within 10 minutes of blood draw without sequelae. |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| No Related Adverse Events |
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