Study of mRNA-1010 Influenza Vaccine Compared to Standard Flu Vaccine in Adults 50 Years and Older

3 1 1 1

What is this study about?

This clinical trial focuses on testing a new influenza vaccine called mRNA-1010 in comparison with an already approved flu vaccine. The study aims to determine how safe and effective the new vaccine is in protecting adults aged 50 and older against the flu. The new vaccine uses messenger RNA technology, which is different from traditional flu vaccines.

During the study, participants will receive either the new mRNA-1010 vaccine or a standard licensed influenza vaccine called Influsplit Tetra through an intramuscular injection. Both vaccines are designed to protect against different strains of influenza viruses. The study will monitor participants for any side effects and track how well the vaccines prevent flu-like illness caused by influenza viruses.

The research team will collect information about vaccine reactions in the first week after vaccination, track any unexpected health issues for 28 days, and continue monitoring participants’ health for approximately 6 months. They will also measure how well the body’s immune system responds to the vaccines by checking blood samples and documenting any cases of flu-like illness that occur during the study period.

1 Initial screening and eligibility check

A pregnancy test will be performed if you are capable of becoming pregnant

Your eligibility for the study will be verified based on medical criteria

2 Day 1 (Baseline Visit)

You will receive a single intramuscular injection of either the study vaccine (mRNA-1010) or the comparison flu vaccine

This is an observer-blind study, which means you will not know which vaccine you receive

3 First week monitoring (Days 1-7)

You will be monitored for any immediate reactions at the injection site (such as pain or swelling)

Any body-wide reactions (such as fever or tiredness) will be recorded

4 Follow-up period (Days 1-28)

Any unexpected health changes will be documented

A blood sample will be taken on Day 29 to measure your body’s immune response to the vaccine

5 Extended monitoring (Days 1-181)

You will be monitored for approximately 6 months for any flu-like illness

If you develop flu symptoms, a test will be performed to confirm if you have the flu

Any significant medical events or serious health changes will be recorded

6 End of study period

The study concludes after approximately 181 days (6 months)

Final health assessments will be performed

Who Can Join the Study?

  • Must be able to provide signed informed consent and follow all study requirements and restrictions
  • Must be an adult aged 18 years or older
  • Can be either male or female
  • For female participants who can become pregnant:
    • Must not be breastfeeding
    • Must use an acceptable form of birth control starting at least 28 days before the study and continuing until 90 days after the first day of the study
    • Must have a negative pregnancy test (urine or blood) during screening and before receiving the study treatment
  • Female participants who cannot become pregnant (for example, post-menopausal or surgically sterile) are eligible to participate
  • Must be willing to comply with all scheduled visits and study procedures as outlined in the study protocol

Who Cannot Join the Study?

  • History of severe allergic reactions to any vaccine components or previous influenza vaccines
  • Current participation in another clinical trial or use of any investigational drug within 28 days before study enrollment
  • Received any influenza vaccine within 6 months prior to screening
  • Active autoimmune disease requiring systemic treatment (a condition where the immune system attacks healthy cells in the body)
  • Compromised immune system or taking medications that suppress the immune system
  • Acute illness or fever (temperature ≥38.0°C/100.4°F) within 72 hours before vaccination
  • Pregnant or breastfeeding women
  • History of Guillain-Barré syndrome (a rare disorder where the immune system attacks the nerves)
  • Blood disorders or conditions that make you bleed or bruise easily
  • Active infection requiring medical treatment
  • Receipt of blood products or immunoglobulins within 3 months before study enrollment
  • Any medical condition that, in the opinion of the study doctor, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Berliner Centrum Fur Reise Und Tropenmedizin GmbH Berlin Germany
Klinische Forschung Karlsruhe GmbH Karlsruhe Germany
Rokotetutkimuskeskus Finvac Oy Tampere Finland
Al Mare Perearstikeskus OU Tallin Estonia
Innomedica OÜ Tallin Estonia
Vee Perearstikeskus OÜ Paide Estonia

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Universitair Ziekenhuis Gent Gent Belgium
FutureMeds GmbH Berlin Germany
Klinische Forschung Hannover-Mitte GmbH Hanover Germany
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Medizentrum Essen Borbeck Essen Germany
IKF Pneumologie GmbH & Co. KG Frankfurt Germany
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH Oldenburg In Holstein Germany
Smo Md GmbH Magdeburg Germany
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD Montana Bulgaria
Siteworks GmbH Hanover Germany
Medical Center Excelsior OOD Sofia Bulgaria
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
Medical Center Doctor Staykov EOOD Burgas Bulgaria
Kliiniliste Uuringute Keskus OÜ Tartu Estonia
Klinische Forschung Berlin GbR Berlin Germany
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Anima Diepenbeek Belgium
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Clinical Research Hamburg GmbH Hamburg Germany
Center for Clinical and Basic Research AS Tallin Estonia
Medicinski Center Syrtuin Ltd. Sofia Bulgaria
Ftwtffxaok Gvxd Offenbach Am Main Germany
Kzzrpfnvv Fukggytku Dgpiyhy Gvbe Dresden Germany
Encfase Mechelen Belgium
Sepgjjlkm Pmbbxbrytys Smwnmpmayz Rvdncvcwxw Schleswig Germany
Swk Sfm Kullvtvotp Akn Ecoyc Gyfcs Omd Pazardzhik Bulgaria
Dgjsdlloor Cvmhekiizk Cwqrir 1 Sdezsd Eajl Sliven Bulgaria
Oovzuafmwv Cavzbz Flo Iuknxdqrbr Pxmfzohj Fjb Sxdhifkebjl Msurrwo Awgscripjy In Rgwnupemcler Dhh Gdwkjxk Rltzfdep Abhqqjxm Evvo Plovdiv Bulgaria
Occmcwxpbt Coizcs Fbh Ijnfxlbyiw Pqvkmwah Fkp Ptlioqh Crpw Dxvaax Lpovka Kwisdb Eblw Plovdiv Bulgaria
Ajjjrxyrxx Fcy Ipkfbbhstf Pznlmkkx Fhh Pbhxvso Mfatqzj Apn Afuzeq Dcx Zrmeohh Dxwazdig Eajw Stamboliyski Bulgaria
Ukylvysmkc Of Anwyhaf Edegem Belgium
Hsnijrjr Ukbszphvsn Cklpjpq Hqjrarby Helsinki Finland
Mpxriajc Mywazbk Afnjhia Pleven Bulgaria
Souacfnzkjptlc Dli Kecmsj Frankfurt Germany
Mikanmg Cxxysu Mnooaibrcq Pncjyl Owy Pleven Bulgaria
Dkunvkmqiach Qmhnq Mainz Germany
Gxnbclfnjnmhesoxqsy Mjivvncwfhhzn &sbfzes Dts Lv Pjevbtdmgq Tp Dvjvyysw Stuhr Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
02.09.2024
Bulgaria Bulgaria
Not recruiting
02.09.2024
Estonia Estonia
Not recruiting
02.09.2024
Finland Finland
Not recruiting
02.09.2024
Germany Germany
Not recruiting
02.09.2024

Trial locations

mRNA-1010
This is an investigational seasonal influenza vaccine using messenger RNA technology. It’s designed to protect against influenza A and B strains. The vaccine works by teaching the body’s cells to produce proteins that trigger an immune response against the flu virus.

Licensed Inactivated Seasonal Influenza Vaccine
This is a standard, approved flu vaccine that contains inactivated (killed) flu viruses. It helps protect against seasonal influenza by stimulating the immune system to produce antibodies against the flu virus. This vaccine serves as the comparison (active control) in this study.

Investigated diseases:

Influenza – A highly contagious viral respiratory infection that affects the nose, throat, and sometimes the lungs. The virus spreads through tiny droplets when infected people cough, sneeze, or talk. Symptoms typically appear suddenly and include fever, chills, muscle aches, fatigue, headache, dry cough, and runny or stuffy nose. The illness usually develops within 1-4 days after exposure to the virus. Most people recover within a few days to less than two weeks.

Trial ID:
2024-516240-26-00
Protocol code:
mRNA-1010-P304
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Immune Responses to Avian Influenza Vaccine with A/Turkey/Turkey/1/05 (H5N1)-Like Strain in Patients with Avian and Seasonal Influenza

    Recruiting

    3 1 1 1
    Investigated diseases:
    Finland
  • Study on the Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Preventing Flu in Adults Aged 65-79 in Galicia, Spain

    Recruiting

    3 1 1 1
    Investigated diseases:
    Spain