Testing the Immune Response to Trivalent Inactivated Influenza Vaccine in People with Obesity and Type 2 Diabetes

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What is this study about?

This study examines how well the influenza vaccine works in people with obesity and type 2 diabetes. The vaccine being used is called Vaxigrip, which is a standard dose shot that protects against three strains of the flu virus. The study will also include pregnant women and people with normal body weight for comparison. The purpose of the study is to measure how the immune system responds to the vaccine in people with obesity and to see how many people develop protective levels of antibodies against the flu after getting vaccinated.

Participants will receive one injection of the vaccine into a muscle. Blood samples will be taken before the vaccination and again 14 days after the vaccination to measure the level of antibodies, which are proteins that help fight off infections. The study will check how many people reach a protective level of antibodies and how many people have a significant increase in antibody levels after vaccination. The vaccine contains inactive flu virus particles that cannot cause the flu but help the body build protection against it.

During the study, any side effects will be recorded, including reactions at the injection site such as pain or redness, and general symptoms like fever or tiredness that may occur in the week after vaccination. Any serious health problems or unexpected reactions will also be monitored throughout the entire study period. The study will compare the vaccine response between different groups including people with obesity, people with obesity and diabetes, people with normal weight, and pregnant women with and without obesity.

1 Baseline visit and vaccination

On the first day of the study, referred to as day 0, a blood sample will be taken before receiving the vaccine. This sample will be used to measure the level of antibodies in your blood.

You will receive one dose of Vaxigrip, which is an influenza vaccine. The vaccine contains inactivated influenza virus strains including influenza virus b/michigan/01/2021, influenza a/victoria/4897/2022 (h1n1), and influenza a virus, a/croatia/10136rv/2023 (h3n2).

The vaccine will be administered as an injection into the muscle, typically in the upper arm.

After receiving the vaccine, you will be asked to monitor and record any reactions at the injection site or any general symptoms for the following 7 days.

2 Monitoring period for side effects

For 7 days after vaccination, you should note any reactions at the injection site, such as pain, redness, or swelling.

You should also record any general symptoms you experience during this period, such as fever, headache, or muscle aches.

Any serious adverse events, unexpected reactions, or severe health problems should be reported throughout the entire study period.

3 Follow-up visit

At 14 days after vaccination, you will attend a follow-up visit.

A second blood sample will be taken to measure the level of antibodies in your blood. This will be compared to the level measured before vaccination to assess how your immune system responded to the vaccine.

The blood test will specifically measure antibodies using a method called Hemagglutination Inhibition Assay, which determines whether you have developed protective immunity against influenza.

4 Continued safety monitoring

Throughout the entire study period, any serious adverse events, unexpected health problems, or fatal events will be monitored and recorded.

You should report any significant health changes that occur from the time of vaccination until the end of the study.

Who Can Join the Study?

  • You must be able to give your written consent to take part in the study.
  • If you are a woman who can become pregnant, you must use adequate contraception, which means reliable birth control methods to prevent pregnancy during certain parts of the study.
  • For some groups in the study, you must have obesity, which means your BMI (Body Mass Index, a measure of body weight compared to height) is 30 or higher.
  • You must be between 18 and 50 years old when you join the study.
  • Depending on which group you are in, you may need to have type 2 diabetes (a condition where your body does not use sugar properly) or you may need to not have diabetes.
  • For some groups, you must not be obese, which means your BMI should be between 18.5 and 29.9.
  • For one specific group, you must have normal body weight, which means your BMI should be between 18.5 and 24.9.
  • For certain groups, you must be pregnant and have passed week 12 of your pregnancy.

Who Cannot Join the Study?

  • The study did not provide specific exclusion criteria in the available information
  • If you have questions about whether you can participate in this study, you will need to discuss your individual health situation during the screening process
  • General factors that typically prevent participation in vaccine studies may include having a severe allergic reaction (a serious response by your body’s defense system) to vaccines in the past
  • Having a weakened immune system (your body’s natural defense against infections) due to certain conditions or medications may be a reason for exclusion
  • Being pregnant or planning to become pregnant during the study period may prevent participation
  • Having received another vaccine recently or taking part in another medical study at the same time may not be allowed
  • Having a fever (higher than normal body temperature) or acute illness (a sudden and severe sickness) at the time of vaccination may require delaying participation

Where you can join this trial?

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Other Sites

Site Name City Country Status
Region Stockholm – SLSO Stockholm Sweden

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

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
03.11.2025

Trial locations

Vaxigrip is a flu vaccine that helps protect against three different strains of influenza virus. It is called a trivalent inactivated vaccine, which means it contains killed virus particles that cannot cause the flu but help your body build protection against it. The vaccine is given as an injection to help your immune system recognize and fight off the flu if you are exposed to it. This study is looking at how well this standard dose flu vaccine works in people with obesity and how safe it is for them.

Influenza – Influenza is a contagious respiratory illness caused by influenza viruses that infect the nose, throat, and sometimes the lungs. The disease spreads easily from person to person through droplets when infected individuals cough, sneeze, or talk. Symptoms typically appear suddenly and include fever, body aches, headache, tiredness, cough, sore throat, and stuffy or runny nose. The illness usually develops quickly over a few hours and can last from a few days to about two weeks. Most people recover on their own, though some may experience prolonged fatigue after other symptoms improve. The severity can vary from mild discomfort to serious complications, particularly in certain groups of people.

Obesity – Obesity is a medical condition characterized by excessive accumulation of body fat that may negatively affect health. It develops when a person regularly consumes more calories than the body uses for energy over an extended period. The excess energy is stored as fat in various parts of the body, gradually increasing body weight and fat tissue. Obesity typically progresses slowly over months or years as eating and activity patterns remain unchanged. The condition can worsen over time as increased body weight may make physical activity more difficult, potentially leading to further weight gain. Various factors including eating habits, physical activity levels, genetics, and environmental influences contribute to its development.

Type 2 Diabetes – Type 2 diabetes is a chronic condition that affects how the body processes blood sugar, also known as glucose. In this disease, the body either resists the effects of insulin or does not produce enough insulin to maintain normal glucose levels. The condition typically develops gradually over several years, often beginning with a stage called prediabetes where blood sugar levels are higher than normal but not yet high enough to be classified as diabetes. As the disease progresses, the pancreas struggles to produce sufficient insulin to overcome the body’s resistance, leading to increasingly elevated blood sugar levels. Many people may not notice symptoms in the early stages, which can allow the condition to advance undetected. Over time, consistently high blood sugar levels can affect various organs and systems throughout the body.

Trial ID:
2025-522698-13-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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