Thanks for showing interest in our work!
We are conducting a study on the safety and efficacy of a vaccine against the Respiratory Syncytial Virus. Our aim is to protect babies by vaccinating their mothers.
Hello! I’m Carol, the doctor in charge of this research project.
THIS IS CALLED MATERNAL IMMUNIZATION
This means vaccines given to women like you during pregnancy. This vaccine can protect you, your new-born or both against serious infectious diseases.
Maternal immunisation helps to increase your defences. Defences can be transferred through the placenta to indirectly protect babies who are too young to be immunised. In other words, this vaccine protects you, and indirectly, your baby.
After immunisation, your defences are transferred to the baby through breast milk.
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This is a Phase III Study
This is a randomised, observer-blind, placebo-controlled study.
Our aim is to determine the capacity of a mother’s immune system and her baby’s to react to the RSV virus (against Respiratory Syncytial Virus).
It is given to healthy, pregnant women during the third trimester of pregnancy.
It also determines the safety and efficacy of the protection transferred by the vaccine.
Clinical trials are medical research studies in which volunteers register to test out treatments that can prevent, detect or cure diseases. These volunteers may be either healthy or sick people.
Clinical trials are conducted to evaluate a new vaccine before it is administered. The use of a new vaccine must be approved for the general population.
The vaccine under study is first assayed in the laboratory and then tested in clinical trials.
Several clinical trials are conducted before a vaccine can be administered to the population. This way, we know it is safe and efficacious.
Finally, the national health authorities review the study results and decide on approval.
Clinical trials are performed in a series of steps called “phases”
Each phase has a different aim and helps researchers answer different questions.
HERE’S OURS! Phase III trials: the new drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, to control side effects, to compare it with standard or similar treatments, and gather information that allows the new drug or treatment be used safely.
The vaccine we will use is a new vaccine. It is a biological product, derived from a living organism and used for the prevention of disease caused by RSV in new-borns.
THE TRIAL
In this study we aim to find out if we can protect your baby from respiratory syncytial virus (RSV) infections. We do this by vaccinating you while you are pregnant.
Respiratory syncytial virus (RSV) causes lung infections such as pneumonia and bronchiolitis in children under 2 years of age.
It is also a significant cause of hospitalisation and infant death worldwide.
WHAT DOES THE RESPIRATORY SYNCYTIAL VIRUS (RSV) CAUSE?
RSV causes mild, cold-like symptoms in adults and older healthy children. It can cause serious problems in young babies, such as pneumonia and serious respiratory problems.
Premature babies and babies with other health problems have a higher risk of complications after infection with this virus
If your child becomes infected with RSV, he or she may develop fever, nasal congestion, cough and shortness of breath. Laboratory tests can determine if your child has the virus.
There is no specific treatment for this disease, but you can give more fluids to your child to avoid dehydration. If necessary, you can also administer an analgesic, or painkiller (not an aspirin), for fever and headache.
RSV spreads easily from person to person. You can get it from direct contact with someone who has it or by touching infected objects like toys or surfaces such as countertops.
The spread of RSV infection can be prevented if you wash your hands frequently and do not share eating and drinking utensils.
There is currently no vaccine for RSV on the market.
RSV CAN CAUSE PNEUMONIA
Pneumonia is the swelling or inflammation of the tissue in one or both lungs. It is usually caused by a bacterial infection.
RSV CAN ALSO CAUSE BRONCHIOLITIS
Bronchiolitis is a common infection of the lower respiratory tract that affects babies and children under 2 years of age.
Most cases are mild and disappear in 2 to 3 weeks without treatment, although some children develop severer symptoms and require hospital treatment.
It is given to you while you are pregnant so that it could provide protection to your child through the placenta at birth (antibody transfer).
WHAT ARE ANTIBODIES?
Antibodies are substances created by the body that help protect us against viruses and infectious bacteria.
We are conducting this study to help prevent RSV infection.
It is easier for a child to catch this infection in the first few months of life.
We invite you to participate in our study.
This is a randomised, observer-blind, placebo-controlled clinical trial intended for women in the third trimester of pregnancy.
This study complies with European Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of April 16, 2014, on clinical trials of medicinal products for human use and has been approved by an Ethics Committee specialised in this field.
GLOSSARY
ETHICS COMMITTEE
Independent review body that studies and approves/disapproves biomedical research in humans.
An approval from the Ethics Committee is required for each clinical study protocol and main researcher before the start of the study.
RANDOMISATION
This is the process by which treatments are assigned to participants by chance rather than by choice, like heads or tails.
Randomisation is done to avoid any bias (inequality) in the assignment of volunteers receiving one kind of treatment or another.
BLINDING
This is a way to ensure that people involved in a research study, such as participants in clinical trials, do not know which trial group they have been assigned to.
For example, in a trial with a treatment group and a placebo group, “observer-blinding” means that participants do not know if they are actually receiving the treatment or merely a placebo.Ours is an observer-blind study. This means that neither the participant, nor the research team (including the medical staff) will know which group you are in.
PLACEBO
This is an injection that looks like the new vaccine but has no therapeutic effect or active ingredients. Although it does not act directly through body mechanisms, placebo can have a positive or negative effect on the person through the mind.
Placebo and nocebo effects result from the belief of having received the actual drug or vaccine, even though they have not.
The term “placebo-effect” refers to the positive consequences of administering a placebo. Those effects result from the belief that the drug can cure certain diseases.
When those outcomes are negative, they are called nocebo-effect. The nocebo-effects are typically linked to the patient’s previous experiences or expectations of having a negative side effect.
Comparing a new product with a placebo is probably the fastest and most reliable way to show the effectiveness of the new product.
VACCINE
This is a biological product that improves immunity against a particular disease.
Spain, the United Kingdom and Romania are the countries in which we will conduct this study.
The trial will include 636 women in the third month of pregnancy.
Ages are from 18 to 40 years.
Pregnancy should neither be multiple nor high-risk.
EXPERIMENTAL GROUP
The vaccine against RSV
CONTROL GROUP
Placebo
In the assay, there will be two groups of participants
You may either be in the experimental group or the control group. This will depend on a computer calculation, like heads or tails.
The experimental group will receive the study vaccine and the control group will receive the placebo.
NEITHER THE DOCTOR, NOR THE NURSE, NOR YOU WILL KNOW WHAT GROUP YOU ARE IN.
But don’t worry, in the event of an emergency, the doctor in charge will be able to know.
Step 1
PREGNANCY
Once you accept, we will ask for your informed consent. The nurse will give you your first injection in your arm muscle. This shot may be the study vaccine or the placebo, depending on the group you have been assigned to. This will happen on day 0.
Step 2
MOTHER STUDY
Here, we will conduct a follow-up for the complete term of your pregnancy. On day 7 and in month 9 of pregnancy.
Step 3
DELIVERY
After delivery, you will be asked to give us your consent again so we can carry out follow-ups on both you and your baby.
Step 4
MOTHER AND BABY STUDY
If you give us your informed consent, we will do follow-ups on you and your baby for 1 year after delivery. This will happen in month 3, 6 and 12.
How will this study affect my lifestyle?
While taking part in this study, you’ll have to come to your health centre on the scheduled dates so we can run some tests.
We also want you to inform us of any changes you may observe in your health status.
We would also like you to watch out for our phone calls and make yourself available if we have to contact you for any reason.
Your participation in the study requires a little time and dedication, but we’ll try to make it compatible with your work, studies and/or family life.
Here is a summary of the visits you will have.
1st VISIT
The nurse gives you a vaccine during the last few months of your pregnancy.
That same day, the nurse takes a 20 ml blood sample.
2nd VISIT
One week later, you come back to your doctor so we can check that you are well. The nurse takes another blood sample.
3rd VISIT
In the ninth month of pregnancy, we meet up again. Our doctor checks that you are well, and the nurse takes another blood sample
4th VISIT
3 months after delivery, you return with your baby for a check-up and the nurse takes a blood sample from your baby, maximum only 2 ml.
5th VISIT
6 months after delivery, you return with your baby for a check-up and the nurse takes a blood sample from you and from your baby.
6th VISIT
12 months after delivery, you return with your baby for a check-up and the nurse takes a blood sample from your baby.
GLOSSARY
ADVERSE EVENT
An adverse event is any unfavorable medical event in a patient or subject of a clinical trial to whom medication had been administered. The event and the treatment do not necessarily have to have a causal relationship.
BLOOD SAMPLE
Blood samples are laboratory tests which consist of extracting a bit of the patient’s blood. They are normally used to help doctors detect changes in your health, diagnose medical conditions, plan or evaluate treatments and/or control diseases.
If you experience an adverse event, you should inform your doctor.
For example: if you have been admitted to hospital; if you had to see a doctor; if any changes were made to the medication you were taking.
POSSIBLE ADVERSE EVENTS (RISKS) AFTER VACCINATION
All medications are carefully studied before being administered to people. But even so, adverse events may occur during the study. Don’t worry, though, we’ll be looking after you and your baby very well.
VERY FREQUENT
Headache, nausea, muscle pain, pain at the injection site, redness at the injection site (≤50mm), hardening at the injection site (≤50mm) or general malaise.
FREQUENT
Skin rash, joint pain, redness at the injection site (>50mm), hardening at the injection site (>50mm), fever ≥38°C and chills.
LESS FREQUENT
As with all vaccines, strong or unforeseen allergic reactions may occur, manifesting as a rash on the hands and feet that causes itching, swelling of the eyes and face, and difficulty breathing and swallowing. In some cases, the allergic reactions can affect the wellbeing of your baby. Because of this, it might require additional monitoring with ultrasound or we might ask you to stay at the hospital for a longer period. Sometimes these reactions can lead to preterm abortion.
POSSIBLE EFFECTS AFTER A BLOOD SAMPLE
Blood sampling may cause minor discomfort such as dizziness, pain, bruising, redness, irritation, and very rarely, infection at the extraction site.
All you have to do is stay with us for a little while afterwards!
Usually, these reactions occur before you leave your medical centre.
So after receiving the vaccine, we’ll ask you to stay with us for about half an hour. That’s so we can watch over you and help you if a reaction occurs.
If you want to find out about other risks related to the use of this vaccine, you can consult your general practitioner. Your GP is always there for you.
If you notice anything other than what we’ve described,
or some other side effect, and you think it may be serious:
Let us know or consult your doctor!
In any case, we’re always available for you.
BENEFITS OF PARTICIPATING
The study vaccine may be beneficial in reducing the risk of RSV infection for you and your baby. But it is also possible that the vaccine does not have any effect on your baby.
You will be informed of the results of this study after completion.
You will receive personalised medical attention throughout your pregnancy.
The vaccine, the tests and the study procedure do not involve any cost or expense for you.
You cannot participate in this study if you plan to get another vaccine against RSV outside of this trial.
Talk to your doctor about your options before deciding to participate in this study.
Our study doctor can also advise you in case you need further information.
- WHO PAYS FOR THIS STUDY?
- WHAT HAPPENS TO MY MEDICAL AND PERSONAL INFORMATION?
- WHAT HAPPENS TO MY BLOOD SAMPLES?
The sponsoring company, which is also the promoter of this study.
The promoter develops, manufactures and markets vaccines, medications and other health products.
The research team and the hospital receive financial compensation from the promoter for conducting this study.
Your participation in the study will not involve any expense for you.
We will also take care of your transfers to the health centre. Study staff will provide you with a telephone number of a taxi service so you can come to the centre for your visits.
In order to evaluate study results better, it may be necessary to send images, clinical reports or tests to central review teams.
Your medical and personal information will be kept confidential and secure. A number will be assigned to your file and all information will be identified with the same code to maintain confidentiality.
Your medical and personal information will be kept confidential and secure.
The promoter will protect your information pursuant to applicable legislation.
Once you arrive, we will give you a number (for example, 12345) to ensure your privacy. Your personal information can be linked to you only through this number, which will be safely and confidentially stored in the centre where the study takes place.
Only the doctor of the study and his/her team will have access to your personal information (the one that can tell who you are).
PERSONAL INFORMATION:
Only the doctor of the study and his/her team will have access to your personal information (the one that can tell who you are).
Exception:
In the case of an audit , the promoter of the study, his/her collaborators and the audit in question will also have access to your personal information.
In both cases, all members of the team who have access to your information will protect it according to the applicable regulations.
CODIFIED INFORMATION:
This information cannot be linked to your name, but only to the number you have been given.
Who can use this information?:
The research staff of the centre where the study takes place
The promoter, the third parties working on behalf of the sponsor, or the institutions working with the sponsor (including clinical research ethics committees which approve and supervise studies).
What for?:
Our investigation
Future investigations that are related to ours.
Your blood samples may be sent to the sponsor or to other laboratories working with the sponsor, including some located outside your country. They may be used for the following aims:
- To measure the ability of your body to produce antibodies against the microorganism being studied for this vaccine.
- To guarantee the quality of tests performed with vaccines and/or to study diseases over time.
- To improve tests and develop new tests related to vaccines and/or to study diseases. These tests will never include tests related to the hereditary characteristics of your genes.
Your samples will receive a code so they cannot be identified directly.
You may request the destruction of your samples at any time by contacting the study doctor
They will be labelled with the same code as the rest of the study information and stored in a safe place.
Everyone who works with your samples will keep the information and the results strictly confidential.
The promoter may use your samples or share them with other companies or research institutes to better understand this disease, other related diseases or for the future development of study medication or other related medications.
They will be kept for a maximum of 20 years after the end of the study (counting from the last visit of the last participant to complete the study).
At that time, all remaining samples will be destroyed.
This will allow for further scientific research in the future as new discoveries are made.
BENEFITS OF PARTICIPATING
Participating in a clinical study contributes to medical knowledge. The results of these studies can help us to know better how the vaccine works and learn more about it. Furthermore, they can help us improve the care of other pregnant women and their babies
COMPENSATION
For the inconvenience and the time you dedicate to your participation in this study, you can receive, if you wish, a financial compensation of €30 for each visit to the centre where the study is being conducted. The corresponding taxes will be applied to this amount.
MANAGEMENT OF YOUR SAMPLES
All samples of the study will be managed following the provisions of the Biomedical Research Law 14/2007.
You are free to withdraw your consent for the use of your personal information at any time.
WHAT HAPPENS IF I DECIDE TO LEAVE?
DO I HAVE TO STAY IN THE STUDY UNTIL THE END?
Your participation in the study is voluntary. You can decide at any time not to continue participating, and you do not have to give us any reason for leaving
If you don’t want to participate or you want to leave the trial, you’ll continue to receive the usual medical attention from your doctor.
WHAT WILL HAPPEN IF I DECIDE TO LEAVE THE STUDY?
If you decide to leave the study before finishing it, tell your doctor and he will tell you how to proceed. But if this is the case, we would like to know if your decision is related to an adverse event.
After leaving the study, you will stop receiving the study treatment, but we may ask you to continue sharing information about your health with us.
You can also go to your GP if you need other treatments.
WHAT HAPPENS IF I WITHDRAW MY CONSENT?
If you decide to withdraw your consent, it means that you will not continue with the procedures. You will not come to any more study visits.
We will also stop collecting information about your health derived from your participation.
WILL I SUFFER IN ANY WAY WHILE PARTICIPATING IN THIS STUDY?
The study promoter has an insurance policy that complies with current legislation and will provide compensation in case of injury or deterioration of your health or the health of your baby, occurring in relation to your participation in this study. Talk to the study doctor if you have any questions about this.
Participating in this study?
If you decide to participate in the study, we will give you a copy of your informed consent after signing it.
If you have any questions, contact us
Are you interested in participating in our study?
By signing this form, I agree to:
- Participate in this study.
- Having my samples and data used as described in this form.
+1 123 45 67
If you call this number, a member of our team will answer your questions.
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