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| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
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The purpose of this study is to evaluate the absolute (versus placebo) and relative (one vaccine compared to the other) efficacies of the live attenuated and inactivated influenza vaccines in preventing laboratory confirmed symptomatic influenza caused by circulating strains whether similar or dissimilar to strains included in the vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIV | Active Comparator | the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur |
|
| LAIV | Active Comparator | live-attenuated influenza vaccine Flumist, manufactured by MedImmune |
|
| Placebo | Placebo Comparator | Physiologic saline administered as a nasal spray or intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone | Biological | single dose licensed trivalent inactivated influenza vaccine (2007-08) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza | one influenza season - 2007-2008 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection | Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold S. Monto, MD | University of Michigan School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Public Heatlh | Ann Arbor | Michigan | 48109 | United States | ||
| Western Michigan University Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17167134 | Background | Ohmit SE, Victor JC, Rotthoff JR, Teich ER, Truscon RK, Baum LL, Rangarajan B, Newton DW, Boulton ML, Monto AS. Prevention of antigenically drifted influenza by inactivated and live attenuated vaccines. N Engl J Med. 2006 Dec 14;355(24):2513-22. doi: 10.1056/NEJMoa061850. | |
| 19776407 | Result | Monto AS, Ohmit SE, Petrie JG, Johnson E, Truscon R, Teich E, Rotthoff J, Boulton M, Victor JC. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009 Sep 24;361(13):1260-7. doi: 10.1056/NEJMoa0808652. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluzone - Trivalent Inactivated Influenza Vaccine | the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur |
| FG001 | Flumist - Live-attenuated Influenza Vaccine | live-attenuated influenza vaccine Flumist, manufactured by MedImmune |
| FG002 | Placebo | Physiologic saline administered as a nasal spray or intramuscular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluzone - Trivalent Inactivated Influenza Vaccine | the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur |
| BG001 | Flumist - Live-attenuated Influenza Vaccine |
| 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 | Laboratory-confirmed (Culture and/or PCR) Symptomatic Influenza | ITT | Posted | Number | participants | one influenza season - 2007-2008 |
|
6 months
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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 | Fluzone - Trivalent Inactivated Influenza Vaccine | the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain, vomiting, diarrhea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold S. Monto, MD | University of Michigan School of Public Health | 734-764-5453 | asmonto@umich.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 |
| C000613429 | FluMist |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Flumist |
| Biological |
single dose licensed live-attenuated influenza vaccine Flumist (2007-08) |
|
| Physiologic saline | Other | single dose placebo administered as an intranasal spray or intramuscular injection |
|
| Time between prevaccination visit and postvaccination visit; typically about 30 days. |
| Immune Response to Vaccination and Infection | Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit. | Postvaccination to postseason visit; typically about 3 months. |
| Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. | Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection). | Time between prevaccination and postvaccination, typically about 30 days. |
| Kalamazoo |
| Michigan |
| 49008 |
| United States |
| Central Michigan University Health Services | Mount Pleasant | Michigan | 48859 | United States |
| Eastern Michigan University Health Services | Ypsilanti | Michigan | 48197 | United States |
| 25858957 | Result | Monto AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, Levine M, Katz JM, Ohmit SE. Antibody to Influenza Virus Neuraminidase: An Independent Correlate of Protection. J Infect Dis. 2015 Oct 15;212(8):1191-9. doi: 10.1093/infdis/jiv195. Epub 2015 Apr 8. |
| 21998477 | Result | Ohmit SE, Petrie JG, Cross RT, Johnson E, Monto AS. Influenza hemagglutination-inhibition antibody titer as a correlate of vaccine-induced protection. J Infect Dis. 2011 Dec 15;204(12):1879-85. doi: 10.1093/infdis/jir661. Epub 2011 Oct 12. |
| 31117986 | Derived | Gilbert PB, Fong Y, Juraska M, Carpp LN, Monto AS, Martin ET, Petrie JG. HAI and NAI titer correlates of inactivated and live attenuated influenza vaccine efficacy. BMC Infect Dis. 2019 May 22;19(1):453. doi: 10.1186/s12879-019-4049-5. |
| 21378375 | Derived | Petrie JG, Ohmit SE, Johnson E, Cross RT, Monto AS. Efficacy studies of influenza vaccines: effect of end points used and characteristics of vaccine failures. J Infect Dis. 2011 May 1;203(9):1309-15. doi: 10.1093/infdis/jir015. Epub 2011 Mar 4. |
live-attenuated influenza vaccine Flumist, manufactured by MedImmune
| BG002 | Placebo | Physiologic saline administered as a nasal spray or intramuscular injection |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Measure Immune Response Induced by the Vaccines and Identify Serologic Correlates of Immune Protection | Measure immune response induced by the vaccines. Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the prevaccination visit and those collected at the postvaccination visit. | Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms. | Posted | Count of Participants | Participants | Time between prevaccination visit and postvaccination visit; typically about 30 days. |
|
|
|
| Secondary | Immune Response to Vaccination and Infection | Response was defined as greater than or equal to 4 fold rise in antibody titers measured by hemagglutination inhibition (HAI), microneutralization (MN), or neuraminidase inhibition (NAI) assays between sera collected at the postvaccination visit and those collected at the postseason visit. | Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms. | Posted | Count of Participants | Participants | Postvaccination to postseason visit; typically about 3 months. |
|
|
|
| Secondary | Identify Serologic Correlates of Immune Protection. Suggest Changing to: Number of Participants Demonstrating Postvaccination Seroconversion. | Identify serologic correlates of immune protection. Seroconversion is defined as either prevaccination titer of less than 8 and postvaccination titer of greater than or equal to 32 or prevaccination titer of greater than or equal to 8 and greater than or equal to 4 fold rise in strain specific hemagglutination-inhibition (HAI) antibody titer between prevaccination and postvaccination sera. Data is shown separately for cases (subjects with symptomatic influenza A laboratory confirmed by isolation in cell culture or identification in real-time polymerase chain reaction (PCR) assay) and non-cases (subjects without cell culture, real time PCR or serologic evidence of influenza infection). | Protocol only required that a subset of all specimens be run in order to get statistically significant outcomes; because the MN assay is labor intensive a subset of sera was processed in that assay for the Flumist-live attenuated influenza vaccine group to maintain comparable tested sample sizes among the three arms. | Posted | Count of Participants | Participants | Time between prevaccination and postvaccination, typically about 30 days. |
|
|
|
| 8 |
| 814 |
| 0 |
| 814 |
| EG001 | Flumist - Live-attenuated Influenza Vaccine | live-attenuated influenza vaccine Flumist, manufactured by MedImmune | 4 | 813 | 0 | 813 |
| EG002 | Placebo | Physiologic saline administered as a nasal spray or intramuscular injection | 3 | 325 | 0 | 325 |
| Anorexia | Gastrointestinal disorders |
|
| Appendicitis, appendectomy | Gastrointestinal disorders |
|
| Breast Cancer/Mastectomy | Reproductive system and breast disorders |
|
| Cellulitis left leg | Skin and subcutaneous tissue disorders |
|
| Cervical cancer | Reproductive system and breast disorders |
|
| Cholecystitis, cholecystectomy, cholelithiasis | Hepatobiliary disorders |
|
| Depression/anxiety | Nervous system disorders |
|
| Head injury bike accident | Surgical and medical procedures |
|
| Mononucleosis | Infections and infestations |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
|
| surgical repair of torn ACL | Musculoskeletal and connective tissue disorders |
|
| surgury - remove tumor in left ovary/fallopian tube | Reproductive system and breast disorders |
|
| Cholecystitis, cholecystectomy, cholelithiasis | Hepatobiliary disorders |
|
| Appendectomy | Gastrointestinal disorders |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| NAI assay |
|
|
| MN assay |
|
|
| NAI assay |
|
|
| MN assay |
|
|
| Noncases |
|
|