One shot for two threats: new combo vaccine tested in seniors

NCT ID NCT06291857

Vaccine Sponsor: Novavax Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This large, final-stage study tested a new combination vaccine that aims to protect against both COVID-19 and the flu with a single shot. About 9,300 adults aged 65 and older took part, receiving either the combo vaccine or a standard high-dose flu vaccine. Researchers checked how well the vaccines triggered an immune response and monitored safety over a year.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

9,320 people

The number who actually took part.

Started

Dec 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria To be included in this study, each individual must satisfy all the following criteria: 1. Willing and able to give informed consent prior to study enrollment. 2. Medically stable adult male or female ≥ 65 years of age at Screening. 3. Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by: 1. Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity; 2. Absence of medical events qualifying as SAEs within 3 months; and 3. Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator. 4. The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening. 5. Participant must be able to receive an injection in the deltoid of at least 1 arm. 6. Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs. 7. Participants must have completed a primary vaccination series/booster against SARS CoV-2 with an authorized/approved COVID-19 vaccine, with receipt of last dose of authorized/approved vaccine (with or without boosters\[s\]) ≥ 8 weeks prior to vaccination. 8. Female participants must be surgically sterile (ie, have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as amenorrhea at least 12 consecutive months) 9. Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study. Note: For participants who become hospitalized with COVID-19 or influenza, participation in investigational treatment studies is permitted. Exclusion Criteria If an individual meets any of the following criteria, he or she is ineligible for this study: 1. History of laboratory-confirmed (by polymerase chain reaction \[PCR\], rapid antigen test, or rapid molecular assay) COVID-19, asymptomatic SARS-CoV-2 infection, or influenza within ≤ 8 weeks prior to Screening. 2. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the investigator). This includes any current workup of undiagnosed illness that could lead to a new condition. 3. Serious chronic diseases inclusive of: 1. Uncontrolled hypertension (NOTE: hypertension ≤ 170/100 is NOT exclusionary); 2. Congestive heart failure requiring hospitalization within 3 months prior to Screening 3. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary); 4. Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary); 5. Hospitalization for diabetic ketoacidosis within 6 months prior to Screening 6. Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening 7. Chronic clinically significant gastrointestinal and hepatic diseases requiring hospitalization or institution of substantive new therapy within 3 months prior to Screening. (for example, gastroesophageal reflux disease is NOT exclusionary) 8. Chronic neurological diseases or neurological compromise preventing access to the study clinic, compliance with protocol, or accurate reporting of safety. 4. Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination. 5. Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination. 6. History of a serious reaction to a prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product. 7. Any history of anaphylaxis to any prior vaccine. 8. History of Guillain-Barré Syndrome following a previous influenza vaccine. 9. Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID-19 and influenza vaccination will not be allowed until after Day 84. 10. Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination (NOTE: well-controlled hypothyroidism and mild psoriasis are not exclusionary). 11. Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted. 12. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study. 13. Active cancer (malignancy) therapy within 1 year prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator). 14. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EoS. 15. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the investigator, might interfere with protocol compliance. 16. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned day of vaccine administration). 17. History of myocarditis or pericarditis. 18. Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting). 19. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study). 20. Known history of any prior motor neuropathy.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

Aotearoa Clinical Trials Trust

Wellington, New Zealand
Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia
CliniTrials

Perth, Western Australia, 6000, Australia
Cmax - Ppds

Adelaide, South Australia, 5000, Australia
Doherty Clinical Trials Limited

Melbourne, Victoria, 3000, Australia
East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia
Emeritus Research - Sydney - PPDS

Botany, New South Wales, 2019, Australia
Emeritus Research -PPDS

Camberwell, Victoria, 3124, Australia
Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia
Griffith University Clinical Trials Unit

Griffith, Queensland, 4222, Australia
Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia
Innovate Clinical Research Pty Ltd

Sydney, New South Wales, 2077, Australia
Institute for Respiratory Health - Midland

Midland, Western Australia, 6056, Australia
Key Health- Bondi Junction

Bondi Junction, New South Wales, 2022, Australia
Lakeland Clinical Trials - Waikato - PCRN-PPDS

Hamilton, 3243, New Zealand
Lakeland Clinical Trials - Wellington - PCRN - PPDS

Wellington, 5018, New Zealand
Mater Hospital Brisbane

South Brisbane, Queensland, 4101, Australia
Menzies School of Health Research

Casuarina, Northern Territory, 0810, Australia
Momentum Darlinghurst

Darlinghurst, New South Wales, 2010, Australia
Momentum Dunedin - PPDS

Dunedin, Otago, 9016, New Zealand
Momentum Hawke's Bay - PPDS

Hastings, Hawke's Bay Region, 4122, New Zealand
Momentum Kapiti - PPDS

Waikanae, 5036, New Zealand
Momentum Lower Hutt - PPDS

Lower Hutt, New Zealand
Momentum Palmerston North - PPDS

Palmerston North, 4414, New Zealand
Momentum Pukekohe - PPDS

Auckland, 2120, New Zealand
Momentum St Leonards

Sydney, New South Wales, 2065, Australia
Momentum Sunshine

Melbourne, Victoria, 3021, Australia
Momentum Taringa

Brisbane, Queensland, 4068, Australia
Momentum Tauranga - PPDS

Tauranga, Bay of Plenty, 3110, New Zealand
Momentum Wellers

Wellers Hill, Brisbane, 4121, Australia
Momentum Wellington - PPDS

Wellington, 6021, New Zealand
New Zealand Clinical Research - Christchurch - PPDS

Christchurch, 8011, New Zealand
Northern Beaches Clinical Research - PPDS

Brookvale, New South Wales, 2100, Australia
Northside Health

Coffs Harbour, New South Wales, 2450, Australia
Novatrials

Kotara, New South Wales, 2289, Australia
Nucleus Network Limited

Melbourne, Victoria, 3004, Australia
Nucleus Network Pty Ltd

Herston, Queensland, 4006, Australia
Optimal Clinical Trials Ltd - North Shore - PPDS

Auckland, 0632, New Zealand
Optimal Clinical Trials Ltd - PPDS

Auckland, 1010, New Zealand
Oztrials Clinical Research

Drummoyne, New South Wales, 2047, Australia
Pacific Clinic Research Network - Rotorua - PCRN - PPDS

Rotorua, 3010, New Zealand
Pacific Clinical Research Network - Auckland - PCRN - PPDS

Auckland, 0622, New Zealand
Pacific Clinical Research Network - Christchurch - PCRN - PPDS

Christchurch, 8013, New Zealand
Paratus Clinical Research - Brisbane Clinic - PPDS

Herston, Queensland, 4006, Australia
Paratus Clinical Research - Canberra - PPDS

Bruce, Australian Capital Territory, 2617, Australia
Paratus Clinical Research - Central Coast - PPDS

Kanwal, New South Wales, 2259, Australia
Paratus Clinical Research - Western Sydney - PPDS

Blacktown, New South Wales, 2148, Australia
Pioneer Clinical Research - North Sydney

North Sydney, New South Wales, 2060, Australia
Ryrie St, Geelong, VIC 3220, Australia

Geelong, Victoria, 3220, Australia
Southern Clinical Trials - Tasman - PCRN - PPDS

Nelson, 7011, New Zealand
Southern Clinical Trials - Totara - PCRN - PPDS

Auckland, 0600, New Zealand
Sutherland Shire Clinical Research - PPDS

Miranda, New South Wales, 2228, Australia
Taylor Square Private Clinic

Surry Hills, New South Wales, 2010, Australia
Telethon Kids Institute

Nedlands, Western Australia, 6009, Australia
University of Melbourne - Melbourne

Melbourne N., Victoria, 3051, Australia
University of the Sunshine Coast, Vitality Village - UniSC Clinical Trials - PPDS

Birtinya, Queensland, 4575, Australia
Veritus Research - Emeritus - PPDS

Bayswater, Victoria, 3153, Australia
Wollongong Clinical Research - PPDS

Wollongong, New South Wales, 2500, Australia

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