# US 11,896,660 B1 · Reducing hospitalization in elderly influenza vaccine recipients

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,896,660 B1
- Document ID: US11896660B1
- Status: Granted
- Kind: B1
- Application number: 15/788,044
- Filed: 2017-10-19
- Granted: 2024-02-13
- Earliest claimed: 2010-10-28
- Assignees: Seqirus UK Limited
- Applicants: Seqirus UK Limited
- Inventors: Nicola Groth
- Web page: https://patentgrep.com/patent/US11896660B1

## CPC

- A61K 39/145: Orthomyxoviridae, e.g. influenza virus
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 39/12: Viral antigens
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 47/00: Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/55: {characterised by the host/recipient, e.g. newborn with maternal antibodies}
- A61K 2039/55566: {Emulsions, e.g. Freund's adjuvant, MF59}
- A61K 2039/70: {Multivalent vaccine}
- C12N 2760/16134: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2760/16234: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

Compared to an unadjuvanted vaccine, an adjuvanted influenza vaccine can reduce by almost a quarter the risk of hospitalization for respiratory illness (e.g. influenza and pneumonia) in elderly recipients. Thus the invention provides a method for immunizing an elderly subject by administering an adjuvanted influenza vaccine, whereby the subject's risk of hospitalization for respiratory illness (e.g. influenza and pneumonia) is reduced relative to an elderly subject who receives an unadjuvanted influenza vaccine.

## Claims

### Claim 1

A method for reducing an elderly subject's incidence of hospitalization for influenza respiratory illness, comprising administering at least a priming, first dose of a tetravalent influenza vaccine adjuvanted with a squalene-containing oil-in-water emulsion to the elderly subject in consecutive influenza seasons, whereby the elderly subject's incidence of hospitalization for influenza respiratory illness is reduced relative to an elderly subject who receives an unadjuvanted influenza vaccine, wherein the elderly subject who receives the adjuvanted tetravalent influenza vaccine is receiving immunosuppressive therapy and ranges from 65-100 years old; further wherein the recipient of the adjuvanted influenza vaccine does not receive an unadjuvanted influenza vaccine during any of the consecutive influenza seasons.

### Claim 2 (depends on 1)

The method of claim 1, wherein the emulsion comprises squalene, α tocopherol, and polysorbate 80.

### Claim 3 (depends on 1)

The method of claim 1, wherein the emulsion has submicron oil droplets with an average diameter ranging from 100 to 250 nm.

### Claim 4 (depends on 1)

The method of claim 1, wherein the adjuvanted tetravalent influenza vaccine is a split virus antigen vaccine.

### Claim 5 (depends on 1)

The method of claim 1, wherein the adjuvanted tetravalent influenza vaccine is a purified surface antigen vaccine.

### Claim 6 (depends on 1)

The method of claim 1, wherein the emulsion has droplets with a size less than 220 nm.

### Claim 7 (depends on 1)

The method of claim 1, wherein at least 90% of the droplets (by volume) in the emulsion have a size less than 200 nm.

### Claim 8 (depends on 1)

The method of claim 1, wherein the adjuvanted tetravalent influenza vaccine is administered intramuscularly.

### Claim 9 (depends on 1)

The method of claim 1, wherein the elderly subject is a community-dwelling elderly subject.

### Claim 10 (depends on 1)

The method of claim 1, wherein the adjuvanted and unadjuvanted vaccines have the same dosage volume, amount of antigen, virus strains, antigen type, and non-adjuvant excipients.

### Claim 11 (depends on 10)

The method of claim 10, wherein the adjuvanted vaccine comprises the unadjuvanted vaccine and an adjuvant.

### Claim 12

A method for reducing an elderly subject's incidence of hospitalization for influenza respiratory illness, comprising administering at least a priming, first dose of a tetravalent influenza vaccine adjuvanted with a squalene-containing oil-in-water emulsion to the elderly subject in consecutive influenza seasons, whereby the elderly subject's incidence of hospitalization for influenza respiratory illness is reduced relative to an elderly subject who receives an unadjuvanted influenza vaccine, wherein the elderly subject who receives the adjuvanted tetravalent influenza vaccine is receiving immunosuppressive therapy and ranges from 65-100 years old, and wherein the concentration of squalene in the oil-in-water emulsion ranges from 2 to 10% by weight; further wherein the recipient of the adjuvanted influenza vaccine does not receive an unadjuvanted influenza vaccine during any of the consecutive influenza seasons.

### Claim 13 (depends on 12)

The method of claim 12, wherein the concentration of squalene in the oil-in-water emulsion ranges from 4.3 to 5% by weight.

### Claim 14 (depends on 12)

The method of claim 12, wherein the adjuvanted tetravalent influenza vaccine is a split virus antigen or purified surface antigen vaccine.

### Claim 15 (depends on 12)

The method of claim 12, wherein the adjuvanted tetravalent influenza vaccine is administered intramuscularly.

### Claim 16 (depends on 12)

The method of claim 12, wherein the adjuvanted and unadjuvanted vaccines have the same dosage volume, amount of antigen, virus strains, antigen type, and non-adjuvant excipients.

### Claim 17 (depends on 16)

The method of claim 16, wherein the adjuvanted vaccine comprises the unadjuvanted vaccine and an adjuvant.

### Claim 18 (depends on 1)

The method of claim 1, wherein the adjuvanted tetravalent influenza vaccine is not administered as a second, booster dose.

### Claim 19 (depends on 1)

The method of claim 1, further comprising administering a second, booster dose of the adjuvanted tetravalent influenza vaccine.

### Claim 20 (depends on 12)

The method of claim 12, wherein the adjuvanted tetravalent influenza vaccine is not administered as a second, booster dose.

### Claim 21 (depends on 12)

The method of claim 12, further comprising administering a second, booster dose of the adjuvanted tetravalent influenza vaccine.