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A Study to Test the Safety and Body’s Response to TETRALITE Influenza Vaccine Compared to Vaxigrip Tetra Vaccine in Healthy Adults Aged 18 to 50 Years

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What is this study about?

This study looks at influenza, which is commonly known as the flu. The study examines a new flu vaccine called TETRALITE, which contains an added substance called an adjuvant that may help the body’s immune system respond better to the vaccine. This new vaccine will be compared to Vaxigrip Tetra, which is an approved flu vaccine that does not contain an adjuvant. Both vaccines are given as an injection into the muscle and are designed to protect against four different flu virus strains. The purpose of the study is to evaluate the safety, tolerability, and the ability of TETRALITE to help the body produce an immune response in healthy people aged 18 to 50 years.

Participants in this study will be randomly assigned to one of three groups. One group will receive TETRALITE with a lower dose of adjuvant, another group will receive TETRALITE with a higher dose of adjuvant, and the third group will receive Vaxigrip Tetra without adjuvant. Each person will receive only one injection during the study. The study is observer-blind, which means that the participants and some of the study staff will not know which vaccine is being given, but this information will be known to others involved in conducting the study.

After receiving the vaccine, participants will be monitored for any reactions or side effects. For the first seven days, specific reactions at the injection site and general symptoms throughout the body will be recorded. Any other health problems will be tracked for 28 days after vaccination. Serious health problems, potential immune-related disorders, and other specific health events will be monitored for 180 days. Blood samples will be taken before vaccination and at several time points afterward, including at 7 days, 28 days, and 180 days, to measure the body’s immune response to the vaccine and to check for any changes in blood test results.

1 Initial screening and preparation

Within 21 days before receiving the vaccine, a medical evaluation will be conducted. This evaluation will include a review of your medical history, a physical examination, and laboratory tests to confirm that you are in good general health.

If you are a woman of childbearing potential, a blood test will be performed during screening to confirm that you are not pregnant.

2 Vaccination day

On Day 1, before receiving the vaccine, baseline laboratory tests will be collected.

If you are a woman of childbearing potential, a urine pregnancy test will be performed before vaccination to confirm that you are not pregnant.

You will receive a single administration of one of the following vaccines by intramuscular injection: TETRALITE with 3 micrograms of vaccine components plus 1 milligram of adjuvant, TETRALITE with 3 micrograms of vaccine components plus 4 milligrams of adjuvant, or VaxigripTetra with 15 micrograms of vaccine components without adjuvant. An adjuvant is a substance added to a vaccine to enhance the body’s immune response.

The vaccine protects against influenza, commonly known as the flu, and contains four different influenza virus strains.

3 First week after vaccination

For 7 days after vaccination, you will be monitored for specific reactions at the injection site, such as pain, redness, or swelling, and for general symptoms throughout your body, such as fever, headache, or muscle aches. These are called solicited adverse events.

On Day 7 (one week after vaccination), blood samples will be collected for laboratory tests to measure your immune response to the vaccine and to check for any abnormal changes in blood cell counts or biochemical values.

4 First month after vaccination

For 28 days after vaccination, you will be monitored for any unexpected side effects or health issues. These are called unsolicited adverse events.

On Day 28 (four weeks after vaccination), blood samples will be collected for laboratory tests to measure your immune response to the vaccine and to check for any abnormal changes in blood cell counts or biochemical values.

5 Follow-up period

For 180 days (approximately six months) after vaccination, you will be monitored for serious adverse events, which are severe health problems that require hospitalization or are life-threatening. You will also be monitored for potential immune-mediated disorders, which are conditions where the immune system may react abnormally, and for adverse events of special interest, which are specific health concerns related to the vaccine.

On Day 180 (six months after vaccination), blood samples will be collected for laboratory tests to measure your immune response to the vaccine and to check for any abnormal changes in blood cell counts or biochemical values. This marks the end of your participation in the study.

Who Can Join the Study?

  • You must provide written signed consent, which means agreeing to participate in the study by signing a document, before any study activities begin.
  • You must be between 18 and 50 years old at the time you sign the consent form.
  • You must be in good general health, which will be checked through your medical history, a physical exam, and blood tests done within 21 days before joining the study.
  • Your BMI (body mass index, a measure that uses your height and weight to assess if you are in a healthy weight range) must be between 18.5 and 35 at the screening visit.
  • If you are a woman, you must not be pregnant or breastfeeding, and you must meet one of these conditions: You cannot have children because you have had surgery such as removal of your uterus, ovaries, or fallopian tubes, or you have gone through menopause (no menstrual periods for at least 12 months), OR you can have children but agree to use reliable birth control methods such as birth control pills (for at least 1 month before the vaccine), an intrauterine device, implant, injection, patch, having a partner who has had a vasectomy, or not having sexual intercourse, starting from at least 1 month before receiving the vaccine and continuing for 3 months after.
  • If you are a woman who can have children, you must have a negative pregnancy test (a test to confirm you are not pregnant) done through a blood sample at the screening visit and through a urine sample before receiving the vaccine on Day 1.
  • You must be willing and able to follow all study procedures and the doctor believes you can complete the study.

Who Cannot Join the Study?

  • The study does not provide specific exclusion criteria, which are reasons why someone cannot join the study
  • You should contact the study team directly to learn about all conditions that would prevent participation in this influenza vaccine study, which is testing a flu shot
  • Generally, clinical trials may exclude people with certain health conditions, allergies (bad reactions to medicines or vaccines), or those taking specific medications, but the exact details are not listed here
  • Women who are pregnant (expecting a baby) or breastfeeding (nursing a baby) are often excluded from vaccine studies, though this is not specifically stated for this trial
  • People with weakened immune systems (the body’s defense against illness) may not be able to participate in vaccine studies
  • Those who have received other vaccines recently or are participating in another study may be excluded

Where you can join this trial?

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Other Sites

Site Name City Country Status
Universitair Ziekenhuis Gent Gent Belgium

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
15.09.2022

Trial locations

Investigated drugs:

TETRALITE is an experimental flu vaccine that contains a lower dose of the regular flu vaccine combined with an added substance called an adjuvant. The adjuvant is included to help the body’s immune system respond better to the vaccine, which may allow for using less of the actual vaccine ingredient while still providing protection against influenza.

VaxigripTetra is a standard flu vaccine that protects against four different strains of influenza virus. In this study, it is being used as a comparison to see how well the new experimental vaccine works.

Investigated diseases:

Influenza – Influenza is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and lungs. The disease spreads from person to person through droplets when infected individuals cough, sneeze, or talk. Symptoms typically appear suddenly and include fever, muscle aches, headache, tiredness, cough, sore throat, and runny or stuffy nose. The illness usually develops rapidly within one to four days after exposure to the virus. Most people recover within a few days to less than two weeks, though some may experience complications. The disease occurs seasonally, with annual outbreaks typically happening during fall and winter months.

Trial ID:
2022-500681-98-00
Protocol code:
TETRALITE-I
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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