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The primary purpose of this study is to demonstrate the efficacy of an investigational Vero-cell derived influenza vaccine to prevent infection in an adult population with an influenza virus that is antigenically similar to one of the three strains in the vaccine. All subjects will be randomized to receive a single 0.5 ml intramuscular injection from one of three lots of seasonal Vero-cell derived influenza vaccine or saline placebo. Subjects will be monitored for 180 days following vaccination for occurrence of adverse events. For determining antibody response, subjects will have one blood draw before and one blood draw 21 days after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | Vero-cell derived influenza vaccine |
|
| Placebo | Placebo Comparator | Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated seasonal influenza vaccine (split virus, Vero cell-derived) | Biological | Trivalent, non-adjuvanted vaccine; dose: 0.5 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens | 21 days to 180 days after the date of vaccination | |
| The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set. | 21 Days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | During the entire 180-day follow-up period |
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Inclusion Criteria:
Male and female subjects who
Exclusion Criteria:
Subjects who have any of the risk factors for complications from influenza infection as defined by the Centers for Disease Control and Prevention (CDC):
Subjects are also excluded if they
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| Name | Affiliation | Role |
|---|---|---|
| Karen Near, MD | Baxter Healthcare Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22267715 | Derived | Ehrlich HJ, Singer J, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Portsmouth D, Kistner O, Barrett PN. A cell culture-derived influenza vaccine provides consistent protection against infection and reduces the duration and severity of disease in infected individuals. Clin Infect Dis. 2012 Apr;54(7):946-54. doi: 10.1093/cid/cir959. Epub 2012 Jan 19. | |
| 22172502 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine | Vero-cell derived influenza vaccine Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Phosphate buffered saline | Other | Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml |
|
| Anaheim |
| California |
| United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Clearwater | Florida | United States |
| Jacksonville | Florida | United States |
| Pembroke Pines | Florida | United States |
| South Miami | Florida | United States |
| Chicago | Illinois | United States |
| Lenexa | Kansas | United States |
| Overland Park | Kansas | United States |
| Lexington | Kentucky | United States |
| Metairie | Louisiana | United States |
| Columbia | Maryland | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Las Vegas | Nevada | United States |
| Rochester | New York | United States |
| Charlotte | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Goose Creek | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Plano | Texas | United States |
| San Angelo | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Norfolk | Virginia | United States |
| Ehrlich HJ, Berezuk G, Fritsch S, Aichinger G, Singer J, Portsmouth D, Hart MK, El-Amin W, Kistner O, Barrett PN. Clinical development of a Vero cell culture-derived seasonal influenza vaccine. Vaccine. 2012 Jun 19;30(29):4377-86. doi: 10.1016/j.vaccine.2011.11.114. Epub 2011 Dec 13. |
| 21329971 | Derived | Barrett PN, Berezuk G, Fritsch S, Aichinger G, Hart MK, El-Amin W, Kistner O, Ehrlich HJ. Efficacy, safety, and immunogenicity of a Vero-cell-culture-derived trivalent influenza vaccine: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2011 Feb 26;377(9767):751-9. doi: 10.1016/S0140-6736(10)62228-3. Epub 2011 Feb 15. |
Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine)
Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine | Vero-cell derived influenza vaccine Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml |
| BG001 | Placebo | Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine) Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml |
| BG002 | 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, Customized | Count of Participants | 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 |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
|
| 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 Subjects Developing Influenza Infection, as Confirmed by Viral Culture and Typing of Naso-pharyngeal Specimens | Intent-to-Treat | Posted | Count of Participants | Participants | 21 days to 180 days after the date of vaccination |
|
|
| ||||||||||||||||||||||||||||||
| Primary | The Consistency of Immune Response Produced by 3 Different Lots of VCIV Based on HIA Titer Values | Consistency of each strain across the 3 different lots shown by comparison of the ratios of geometric mean HIA titers at Day 21 between individual lots for the immunogenicity analysis set. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titers | 21 Days after vaccination |
|
| ||||||||||||||||||||||||||||||
| Secondary | Frequency and Severity of Occurrence of Any Injection Site Reactions and Systemic Reactions/Adverse Events Related to Vaccination | Posted | Count of Participants | Participants | During the entire 180-day follow-up period |
|
|
adverse events were recorded during the entire 180-day follow-up period
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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 | Influenza Vaccine | Vero-cell derived influenza vaccine Inactivated seasonal influenza vaccine (split virus, Vero cell-derived): Trivalent, non-adjuvanted vaccine; dose: 0.5 ml | 1 | 1,829 | 3 | 1,829 | 1,132 | 1,829 |
| EG001 | Placebo | Phosphate buffered saline (packaged in syringes identical to those used for the investigational vaccine) Phosphate buffered saline: Packaged in syringes identical to those used for the investigational vaccine; dose: 0.5 ml | 0 | 1,841 | 0 | 1,841 | 375 | 1,841 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Injury, poisoning and procedural complications | Non-systematic Assessment | one subject died as a result of a massive open head trauma due to a single motorcycle collision |
| |
| Hypersensitivity | Immune system disorders | Systematic Assessment | allergic reaction during administration of investigational product |
| |
| Acute disseminated encephalomyelitis | Skin and subcutaneous tissue disorders | Systematic Assessment | subject developed injection site reaction, tingling, burning, itching and numbness after administration of investigational product |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tenderness | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| injection site pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| headache | General disorders | Systematic Assessment |
| ||
| muscle pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| fatigue | General disorders | Systematic Assessment |
| ||
| malaise | General disorders | Systematic Assessment |
| ||
| shivering | General disorders | Systematic Assessment |
| ||
| joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Manager, Clinical & Regulatory Operations | Ology Bioservices | 386-418-8751 | angie.kimbler@ologybio.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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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Counts |
|---|
| Participants |
|
|
|
| Moderate |
|
| Severe |
|
| Unknown |
|