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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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This is an open-label, randomized trial in up to 210 adults aged 65-74 years to evaluate the immune response to consecutive influenza vaccination across 2 seasons. Participants will be randomized to receive 1 of 3 licensed and recommended vaccines in the first year; 2 arms will receive the same vaccination in the second year and the third arm will be randomized again to 1 of 3 licensed vaccines. All participants will have pre and post-vaccination serum blood draws for a total of 6 draws over 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Influenza Vaccine | Active Comparator | This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. |
|
| Adjuvanted Influenza Vaccine | Active Comparator | This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. |
|
| Standard Dose Influenza Vaccine+HD | Active Comparator | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study. |
|
| Standard Dose Influenza Vaccine +Adj | Active Comparator | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. |
|
| Standard Dose Influenza Vaccine+Recomb |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Dose Influenza vaccine | Biological | Licensed and FDA approved Fluzone HD vaccine to be administered to study participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17 | Year 1, Day 28 post vaccination |
| HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17 | Year 1, Day 182 post vaccination |
| HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17 | Year 1, Day 365 post vaccination |
| HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18 | Year 2, Day 28 post vaccination |
| HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18 | Year 2, Day 182 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination | Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17 | Year 1, Day 28 post vaccination |
| HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | 54449 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34774360 | Derived | McLean HQ, Levine MZ, King JP, Flannery B, Belongia EA. Serologic response to sequential vaccination with enhanced influenza vaccines: Open label randomized trial among adults aged 65-74 years. Vaccine. 2021 Dec 3;39(49):7146-7152. doi: 10.1016/j.vaccine.2021.10.072. Epub 2021 Nov 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Influenza Vaccine | This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants |
| FG001 | Adjuvanted Influenza Vaccine | This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants |
| FG002 | Standard+High Dose | This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and high dose influenza vaccination (0.5mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants |
| FG003 | Standard+Adjuvanted | This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants |
| FG004 | Standard+Recombinant | This group will be administered standard influenza vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants. Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Influenza Vaccine | This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | HI Titers, HD vs. AD, Yr 1 Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2016-17 | This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 28 post vaccination |
|
18 months of the study
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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 | High Dose Influenza Vaccine | This group will be administered High Dose (HD) influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Marshfield Clinic Research Institute | 715-389-5088 | king.jennifer@marshfieldresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2017 | Mar 13, 2019 | Prot_SAP_000.pdf |
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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 |
| C528512 | FluBlok |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Active Comparator |
This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. |
|
|
| Adjuvanted Influenza vaccine | Biological | Licensed and FDA approved FluAd vaccine to be administered to study participants |
|
|
| Standard Dose Influenza vaccine | Biological | Licensed and FDA approved Fluvirin vaccine to be administered to study participants |
|
|
| Recombinant Influenza vaccine | Biological | Licensed and FDA approved FluBlok vaccine to be administered to study participants |
|
|
Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17 |
| Year 1, Day 182 post vaccination |
| HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination | Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17 | Year 1, Day 365 post vaccination |
| MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17 | Year 1, Day 28 post vaccination |
| MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17 | Year 1, Day 182 post vaccination |
| MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17 | Year 1, Day 365 post vaccination |
| MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination | Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18 | Year 2, Day 28 post vaccination |
| HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18 | Year 2, Day 28 post vaccination |
| HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18 | Year 2, Day 182 post vaccination |
| HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination | Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18 | Year 2, Day 28 post vaccination |
| HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination | Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18 | Year 2, Day 182 post vaccination |
| Number of Participants With Vaccine Failure, Year 1 | Number of Participants with Vaccine Failure in Year 1 by vaccine type | Year 1, Post season |
| Number of Participants With Vaccine Failure, Year 2 | Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history | Year 2, Post season |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Adjuvanted Influenza Vaccine |
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants |
| BG002 | Standard Dose Influenza Vaccine+HD | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants |
| BG003 | Standard Dose Influenza Vaccine +Adj | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants |
| BG004 | Standard Dose Influenza Vaccine+Recomb | This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study.
|
|
| Primary | HI Titers, HD vs. AD, Yr 1 Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2016-17 | This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 182 post vaccination |
|
|
|
| Primary | HI Titers, HD vs. AD, Yr 1 Day 365 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 365 days post vaccination 2016-17 | This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 365 post vaccination |
|
|
|
| Primary | HI Titers, HD vs. AD, Yr 2 Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 28 days post vaccination 2017-18 | This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 28 post vaccination |
|
|
|
| Primary | HI Titers, HD vs. AD, Yr 2 Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses for high dose and adjuvanted vaccine recipients at 182 days post vaccination 2017-18 | This primary objective evaluated only recipients in the arms receiving high dose and adjuvanted vaccine in year 1. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 182 post vaccination |
|
|
|
| Secondary | HI Response by Prior Season Vaccination, Yr 1, Day 28 Post Vaccination | Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 28 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 28 post vaccination |
|
|
|
| Secondary | HI Response by Prior Season Vaccination, Yr 1, Day 182 Post Vaccination | Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 182 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 182 post vaccination |
|
|
|
| Secondary | HI Response by Prior Season Vaccination, Yr 1, Day 365 Post Vaccination | Hemagglutination inhibition (HI) Titers by prior season (2015-16) vaccination status among adjuvant and high dose vaccine recipients 365 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients by prior season vaccination status. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 365 post vaccination |
|
|
|
| Secondary | MN Titers, HD vs. AD, Year 1, Day 28 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 28 post vaccination |
|
|
|
| Secondary | MN Titers, HD vs. AD, Year 1, Day 182 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 182 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 182 post vaccination |
|
|
|
| Secondary | MN Titers, HD vs. AD, Year 1, Day 365 Post Vaccination | Microneutralization antibody titers to vaccine and drifted viruses among high dose and adjuvanted vaccine recipients 365 days post vaccination, 2016-17 | Secondary objective examines response in adjuvant and high dose recipients to vaccine and drifted viruses. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 1, Day 365 post vaccination |
|
|
|
| Secondary | MN Titers (A/Hong Kong (Siat Cell)), HD vs. AD, Year 2, Day 28 Post Vaccination | Microneutralization antibody titers to vaccine virus (A/Hong Kong (siat cell) among high dose and adjuvanted vaccine recipients 28 days post vaccination, 2017-18 | Secondary objective examines response in adjuvant and high dose recipients to A/Hong Kong (siat cell) virus in year 2, post vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 28 post vaccination |
|
|
|
| Secondary | HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 28 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 28 days post vaccination 2017-18 | This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 28 post vaccination |
|
|
|
| Secondary | HI Titers, HD vs. AD vs. RIV With Prior Season Standard (IIV) Dose, Year 2, Day 182 Post Vaccination | Hemagglutination Inhibition (HI) titers to vaccine viruses among adjuvant, high dose and recombinant recipients with prior season standard dose vaccine at 182 days post vaccination 2017-18 | This secondary objective aimed to look at subjects receiving standard dose vaccine in the previous season and one of 3 licensed vaccines in the 2017-18 season. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 182 post vaccination |
|
|
|
| Secondary | HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 28 Post Vaccination | Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 28 days after vaccination, 2017-18 | This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 28 post vaccination |
|
|
|
| Secondary | HI Titers, IIV+AD or HD vs. Sequential AD or HD, Year 2, Day 182 Post Vaccination | Hemagglutination inhibition (HI) titers among HD and AD based on prior season vaccination (standard or sequential same vaccination) at 182 days after vaccination, 2017-18 | This secondary objective selects individuals receiving high dose or adjuvanted vaccine in year 2 of the study and compares immune response by vaccine received in the prior season. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Year 2, Day 182 post vaccination |
|
|
|
| Secondary | Number of Participants With Vaccine Failure, Year 1 | Number of Participants with Vaccine Failure in Year 1 by vaccine type | Results of influenza surveillance after the first year examines individuals by the vaccine type received in Year 1. | Posted | Count of Participants | Participants | Year 1, Post season |
|
|
|
| Secondary | Number of Participants With Vaccine Failure, Year 2 | Number of Participants with Vaccine Failure in Year 2 by two-year vaccine history | Results of influenza surveillance after the second year examines individuals by groups based on the vaccine types received in both seasons. | Posted | Count of Participants | Participants | Year 2, Post season |
|
|
|
| 2 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Adjuvanted Influenza Vaccine | This group will be administered adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the first and second years of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants | 0 | 58 | 0 | 58 | 0 | 58 |
| EG002 | Standard Dose Influenza Vaccine+HD | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year of the study and high dose influenza vaccine (0.5 mL intramuscular (IM) injection) in the second year of the study. High Dose Influenza vaccine: Licensed and FDA approved Fluzone HD vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants | 0 | 19 | 0 | 19 | 0 | 19 |
| EG003 | Standard Dose Influenza Vaccine +Adj | This group will be administered standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and adjuvanted influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Adjuvanted Influenza vaccine: Licensed and FDA approved FluAd vaccine to be administered to study participants Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants | 0 | 20 | 0 | 20 | 0 | 20 |
| EG004 | Standard Dose Influenza Vaccine+Recomb | This group will be administered a standard dose flu vaccination (0.5 mL intramuscular (IM) injection) in the first year and recombinant influenza vaccination (0.5 mL intramuscular (IM) injection) in the second year of the study. Standard Dose Influenza vaccine: Licensed and FDA approved Fluvirin vaccine to be administered to study participants Recombinant Influenza vaccine: Licensed and FDA approved FluBlok vaccine to be administered to study participants | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| B/Brisbane(Victoria) |
|
| B/Brisbane(Victoria) |
|
| B/Brisbane(Victoria) |
|
| B/Brisbane(Victoria) |
|
| A/H3/Hong Kong |
|
| B/Brisbane(Victoria) |
|
| A/H3/Hong Kong |
|
| B/Brisbane(Victoria) |
|
| A/H3/Hong Kong |
|
| B/Brisbane(Victoria) |
|
| A/H3/NZ0783 (siat cell) |
|
| A/H3/OR19 (siat cell) |
|
| A/H3/NZ0783 (siat cell) |
|
| A/H3/OR19 (siat cell) |
|
| A/H3/NZ0783 (siat cell) |
|
| A/H3/OR19 (siat cell) |
|
|
| B/Brisbane(Victoria) |
|
|
| B/Brisbane(Victoria) |
|
| A/H3/Hong Kong |
|
| B/Brisbane(Victoria) |
|
| A/H3/Hong Kong |
|
| B/Brisbane(Victoria) |
|
| Title | Measurements |
|---|---|
|
| B positive |
|