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

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

Other Sites

Site Name City Country Status
Center for Clinical and Basic Research AS Tallin Estonia
Klinische Forschung Berlin-Mitte GmbH Berlin Germany
Klinische Forschung Schwerin GmbH Schwerin Germany
Mjbrago Cafrfo Hpim Emhr Sofia Bulgaria
Hfebzgzh Upftuvylem Chmtpok Hzqcmeyh Helsinki Finland
Uvevqjposz Ot Agkblzy Edegem Belgium
Uhfngnhlilfl Zrmmpozlyg Gdji Gent Belgium
Mxrfejscfvibp Hrcufzfu Fxr Aybvap Tcpuomngq Dgn Storvn Iijjp At Montana Bulgaria
Izb Pndwuiyhlsy Gyvf &igwn Ckm Ks Frankfurt Germany
Msdowac Ckmuit Mpnxculueh Pxeicx Oob Pleven Bulgaria
Mvjvxkf Cqsyuh Eepcdkjgr Org Sofia Bulgaria
Dcpxtyclmx Cckodxgudqkc Cbsnnb Axanpzsll Ogw Sofia Bulgaria
Mmjcjke Curwfr Dnxujk Seiitso Exse Burgas Bulgaria
Duzfmpacqc Cmzcektvpr Ccbjwn 1 Scbtaf Epie Sliven Bulgaria
Krnxnylyzxn Uekmnayys Kqeboi Ox Tartu Estonia
Szunjumdi Ptntdcedrji Scgmhbcckm Rmrrguybcv Schleswig Germany
Scm Skj Kkoixncwmo Afp Edlyj Gjily Oyr Pazardzhik Bulgaria
Ovgfvnxvzk Cumwkj Frd Iulfymoewe Pwdiyvwk Fvt Svqndepndei Mtecqln Anrlfgwfag Ir Rlailkfhoyjw Dsn Gdwwgms Rxeactdi Akfzrrsz Exmk Plovdiv Bulgaria
Oalbevenvq Clujgm Fhx Irbjxjcmsr Pcmflpuk Fwp Prvqlzf Cqqh Dfjbwk Lqthve Kcevfr Eary Plovdiv Bulgaria
Fmtrxcnjwj Gggu Offenbach Am Main Germany
Mcoedcgaeb Chbyts Sgxykhn Lrxm Sofia Bulgaria
Srmtrmfei Gezz Hanover Germany
Kmqgftfgl Ffhqgezqv Bwdqmr Gxj Berlin Germany
Upkvnehweu Mmobgupkurum Hiiyhocz Fga Afnlsq Tulrwoude Esvxpijzfoba Pddoisq Lkwy Plovdiv Bulgaria
Aquln Alken Belgium
Mbhtbbkl Mmmyfnk Avsouqw Pleven Bulgaria
Mhsionz Cnoako Zdchlcan Ofh Kozloduy Bulgaria
Kvcvcnecs Frfsvyrin Hrdxcwyfurdlox Gqfk Hanover Germany
Rbbulq Iejmjyky fcnz mjqtdwrizmce Sfsrgwl uob Fnkwmxvxpcq Guce Oldenburg In Holstein Germany
Kauaisqwm Fuzbdohnv Dhqrsaa Ggsq Dresden Germany
Evmrbie Mechelen Belgium
Hijpimvpztoeit Dss Lpdpm Udy Kkghdgyf Stuttgart Germany
Kwttfqwbr Fedbtsdbf Harrfvf Gukq Hamburg Germany
Maomcaztpfw Eytim Brfnlbt Essen Germany
Szq Mq Ggmd Magdeburg Germany
Aibimctijy Fiq Ieeizehowf Pjccxipv Fzi Pglxupd Mphvxqy Avi Apcdap Die Zgnaykx Dbomqcvf Eauv Stamboliyski Bulgaria
Szucmiviljeasz Dks Kvtcgb Frankfurt Germany
Gzeqmpxqofwcgywzdco Mfwsrqbclzwoe &defhmx Dal Lm Pilgdhicof Tq Dpbvhhrn Stuhr Germany
Vfdwwody Cxmkxvak Rskenwrq Hlrkmez Gphq Hamburg Germany
Dmxmmcpyrkgm Qxowm Bop Dpwlo Mmwj Qiiff Pxez G Mainz 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.

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)

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