Clinical trial: NCT02860039
Section: Confidentiality
Subsections: 14. **Confidentiality:**|15. **Certificate Of Confidentiality:**|16. Authorization To Use/Disclose Protected Health **Information**

All efforts, within reason, will be made to keep your child's personal information in your child's research record confidential but total confidentiality cannot be guaranteed.  
Information from this study, including your child's identifying information, the United States Food and Drug Administration (FDA) and other regulatory agencies.  
Your child's identity and medical records and data related to this study will be kept confidential, except as required by the law, and except for inspections by Agencies that regulate experimental drug studies (including the FDA), auditors, members of Vanderbilt University Institutional Review Board (IRB), National Institutes of Health (NIH), and/or Sanofi Pasteur, the company that is providing the vaccine. By signing this consent form, you consent to the study doctor and his or her staff to collect and use personal data about your child for the study ("study data"). This includes your child's date of birth, your child's sex, your child's ethnic origin, personal data on your child's physical or mental health or condition and blood collected in the course of this study.  
Your child's study data are protected by the use of a study subject code ("subject identification number"), which is a number specific to your child. The study doctor is in control of the code key, which is needed to connect study data to your child. Vanderbilt may share your child's information, without identifiers, to others or use it for other research projects not listed in this form. Vanderbilt, Dr. Halasa, and her staff will comply with any and all laws regarding the privacy of such information. There are no plans to pay you for the use or transfer of this de-identified information.

To help us protect your child's privacy, we have a Certificate of Confidentiality from the National Institutes of Health (NIH). The researchers can use this Certificate to legally refuse to give information that may identify your child in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify your child.  
A Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about your child or his/her involvement in this research. If you give your consent to release information to a medical care provider, an insurer, or other person to receive research information, then the researchers will not withhold that information.  
The Certificate of Confidentiality *only* applies under US law. Therefore, all specimens and information sent to the US as part of this trial will be protected by the Certificate of Confidentiality.

All efforts, within reason, will be made to keep your child's protected health information (PHI) private. PHI is your child's health information that is, or has been gathered or kept by Vanderbilt as a result of your child's healthcare. This includes data gathered for research studies that can be traced back to your child. Using or sharing ("disclosure") such data must follow federal privacy rules. By signing the consent for this study, you are agreeing ("authorization") to the uses and likely sharing of your child's PHI. If you decide to let your child be in this research study, you are also agreeing to let the study team use and share your child's PHI as described below. As part of the study, Dr. Natasha Halasa and her study team may share the results of your study and/or non-study linked laboratory tests as well as parts of your medical record, to the groups named below. These groups may include people from the Federal Government Office for Human Research Protections, the Food and Drug Administration (FDA), Vanderbilt University Institutional Review Board, NIH, and/or Sanofi Pasteur, the company that supplies the vaccine, and insurance companies for billing purposes. Federal privacy rules may not apply to these groups; they have their own rules and codes to assure that all efforts, within reason, will be made to keep your child's PHI private. The study results will be kept in your child's research record for at least seven years after the study is finished. At that time, the research data that has not been put in your child's medical record will be kept for an unknown length of time. Any research data that has been put into your child's medical record will be kept for an unknown length of time. Unless told otherwise, your consent to use or share your child's PHI does not expire. If you change your mind, we ask that you contact Dr. Natasha Halasa in writing and let her know that you withdraw your consent. Her mailing address is VUMC, 1161 21st Ave. South, D-7235 MCN, Nashville, TN 37232. At that time, we will stop getting any more data about your child. But the health data we stored before you withdrew your consent may still be used for reporting and research quality.  
You have the right to see and copy the PHI we gather on your child for as long as the study doctor or research site holds data. To ensure the scientific quality of the research study you will not be able to review some of your child's data until after the research study is finished. If you decide not to have your child take part in this research study, it will not affect your child's treatment, payment or enrollment in any health plans or affect your child's ability to get benefits. You will get a copy of this form after it is signed.  
Parent/Legal Guardian Signature Date  
  
Printed Name of Parent/Legal Guardian  
  
  
Consent obtained by:  
  
  
Signature of Person & Title Date  
  
  
Printed Name of Person & Title
Clinical trial: NCT02860039
Section: Participant's Rights
Subsections: 12. Who To Call For Any Questions Or In Case You Are **Injured:**

If you should have any questions about this research study or if you feel your child has been hurt by being a part of this study, please feel free to contact Dr. Natasha Halasa at (615) **322-3346** or contact the study team by texting at (615) **200-8479** or by emailing pedsflustudy@vumc.org or hsctflustudy@gmail.com.The study team can also be reached by calling (615) **875-9233** and having Dr.  
Halasa paged at (615) **322-2250**
For additional information about giving consent or your child's rights as a person in this study, please feel free to call the Vanderbilt University Institutional Review Board Office at (615) 322-2918 or toll free at (866) 2248273.
Clinical trial: NCT02860039
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: 3. Costs To You If Your Child Takes Part In This **Study:**|4. Side Effects And Risks That You Can Expect If Your Child Takes Part In This **Study:**|7. Good Effects That Might Result From This **Study:**|9. Payments For You And Your Child'S Time Spent Taking Part In This Study Or **Expenses:**

If you agree to take part in this research study, you and/or your insurance will not have to pay for the tests and treatments that are being done only for research. However, you are still responsible for paying for the usual care you would normally receive for the treatment of your child's illness. This includes treatments and tests you would need even if you were not in this study. These costs will be billed to you and/or your insurance.  
You have the right to ask what it may cost you to take part in this study. If you would like assistance, financial counseling is available through the Vanderbilt Financial Assistance Program. The study staff can help you contact this program. You have the right to contact your insurance company to discuss the costs of your routine care (non-research) further before choosing to be in the study. You may choose not to be in this study if your insurance does not pay for your routine care (non-research) costs and your doctor will discuss other treatment plans with you.

Risks of the Fluzone Quadrivalent® vaccine: Fluzone Quadrivalent® has been shown to be safe in both children and adults. Common side effects include: Redness, swelling, or soreness at the site of the injection, which may last for a few days. Other reactions occasionally experienced include fever, headache, muscle pain, fatigue, chills, nausea, vomiting, diarrhea, and malaise (a feeling of general discomfort).  
Uncommon side effects include: With any vaccination, there is a very small possibility of an allergic reaction, such as a rash, swelling of the lips or face or throat, difficulty breathing, sudden drop in blood pressure, fast pulse, or sweating. If such a reaction occurs, it is usually almost immediately after the vaccination. This is why you will be required to remain in the clinic a minimum of 15 minutes after the vaccine is given so that if this happens, immediate medical attention can be provided.  
During the swine influenza vaccine campaign of 1976, about one per 100,000 vaccine recipients developed a paralytic illness called Guillain-Barré Syndrome (acute and rapidly progressive inflammation of nerves that causes loss of sensation and muscle weakness). This has not been seen consistently with other influenza vaccines. Most patients who develop Guillain-Barré Syndrome recover completely. Groups that recommend use of vaccines for people in your age group state that any risk you might have of developing Guillain-Barré Syndrome is less than that for a complication from illness with influenza. Other neurological disorders, such as encephalopathy (damage to cells in the central nervous system), optic neuritis/neuropathy (inflammation or damage of the optic nerve), partial facial paralysis, and brachial plexus neuropathy (problem with some of the nerves in the shoulder area) have been reported after influenza vaccinations. However, no cause and effect relationship has been established, and full recovery was almost always reported.  
Risks of the High-Dose Fluzone® vaccine: Fluzone® is investigational in children. The same risks are reported for High-Dose Fluzone® as regular Fluzone Quadrivalent®, but there are some reports of increased local symptoms in persons 65 years of age and older compared to standard dose.  
If your child has side effects after getting vaccine, contact the study doctor. Also contact the site if your child has changes in his/her health status.  
Risks of Blood Draw: Pain, redness, soreness, bruising, or infection may occur at the needle stick site. Rarely some people faint. However, we will use your child's central line if they have one to limit these complications.  
Risks in Pregnancy: The risk of Fluzone Quadrivalent® or Fluzone HD® to an unborn baby is not known. If your child becomes pregnant while she is in this study, you must tell your doctor at once. Also, girls must not breastfeed while in this study. If your child is a girl and is able to become pregnant, your child will have urine or blood test to make sure that she is not pregnant before your child receives treatment in this study. 5. Risks that are not **known:**
Because this treatment is investigational, meaning non-FDA approved, there may be risks that we do not know about at this time. 6. Payment in case your child is injured because of this research **study:**
If it is determined by Vanderbilt and the Investigator that an injury occurred as a direct result of the tests or treatments that are done for research, then your insurance will not have to pay for the cost of immediate medical care provided **at Vanderbilt** to treat the injury.  
There are no plans for Vanderbilt to pay for the costs of any additional care. There are no plans for Vanderbilt to give you money for the injury.

a) The benefits to science and humankind that might result from this study:
The information learned in this study may be helpful in the further development of Fluzone HD® for the prevention of flu in SCT patients. The benefits your child might get from being in this study: Your child will receive flu vaccine, which may prevent them from getting the flu. There is no guarantee that your child will benefit from this study. 8. Other treatments your child could get if you decide not to be in this **study:**
Your child does not have to be in this study to get a flu vaccine. Flu vaccines are widely available and are recommended for SCT patients. However, your child will not get the Fluzone HD®.

You or your child will receive $50 for each blood draw, $25 for each vaccine, and $10 for each phone call and/or electronic communication after each vaccine if the memory aid was completed and returned (does not include flu season communication). During the influenza season, you or your child will receive $5 for each week of completed communication. We will pay $10 for each nose swab collected at home and returned to us. We may ask you for your or your child's Social Security number and address before you are compensated for taking part in this study. If your child will be coming to the hospital for a study visit only, we will reimburse you for mileage distance. The standard mileage rate will be $0.58 per mile. This will be calculated depending on the mileage distance between your residence address and Vanderbilt University Medical Center.
Clinical trial: NCT02860039
Section: Procedures
Subsections: Visit 1: Screening & Vaccine Dose Visit (Day 0)|Visit 2: Second Vaccine Dose Visit (Days 28 To 42) Or 4-6 Weeks|Visit 3: Study Visit (28-42 Days Or 4-6 Weeks After Second Vaccine)|Optional Visit 4: Study Visit (180 Days ±42 Days After Visit 2)

The screening visit will take place on the same day your child gets the study vaccine. Before any study-related procedures are done, you will be asked to read and sign a consent form. You may be asked to sign the consent at a visit prior to your child's screening visit. If your child is between 7 and 17 years old, he/she will also sign a separate assent form. The following will be done:
- You will be asked some questions about your child's health.  
- You will be asked if your child is taking any medicines.  
- A health care provider will do a targeted physical exam and oral temperature.  
- You will be asked questions to decide if your child can be in the study.  
- If your child is a girl, she may be asked to give a urine or blood sample for a pregnancy test if she has ever had a period in the past. She will not be able to enter the study if the pregnancy test is positive orif she is breastfeeding A small amount of blood (about 1-2 tablespoons) will be drawn with a needle to test for antibodies (helps the body fight off germs) to flu. Some of the blood may be taken for routine care and some will be taken for research. The blood will be drawn through your child's central line if they have one, if not it will be by getting blood from the vein directly. A second blood draw may be needed if your child is getting IVIG/SCIG.  
- If flu season has started, a nose swab will be done to test for flu.  
- Once the study doctor has made sure it is OK for your child to be vaccinated, he/she will be giveneither Fluzone Quadrivalent® or Fluzone HD®. The vaccine that he/she gets will be decided by chance (like rolling dice), using a special computer program. A nurse will then give your child the vaccine by injecting it with a needle into his or her arm. The study staff will watch your child for at **least 15 minutes**
after getting vaccine.  
You will be given a thermometer. You will be asked to take your child's temperature once every day, at about the same time every day (in the evening). You will be given a memory aid worksheet. This is where you should write down your child's temperature and any symptoms or illnesses that he/she has. Also, write down any new medicine taken, and all extra doctor visits. This starts the day that he/she receives the study vaccine and every day for the next week.  
Telephone and/or electronic communication **(Days 1-3, Days 8-10)**
A study team member will attempt to contact you by telephone and/or electronic communication. The following will be done:
You will be asked about your child's health.  
We will collect the information on the memory aid worksheet.  
We will answer any questions you might have.  
Save the memory aid, you may need to bring in the memory aid worksheet at the next visit or mail it in a provided addressed and stamped envelope after completion. You can also take a picture of the memory aid and send it to the team.

You will be asked to come back to clinic once between 28 to 42 days or 4-6 weeks after the first vaccine was given. Your child will then receive their second dose of the vaccine. This is what will be done:
We will collect the memory aid worksheet if you haven't already returnedit. You will be asked about any changes in medicines that your child is taking. You will be asked about your child's health.  
- A health care provider will do a targeted physical exam and oral temperature.  
If your child is a girl, she may be asked to give a urine or blood sample for a pregnancy test if she has ever had a period in the past. She will not be able to enter the study if the pregnancy test is positive orif she is breastfeeding.  
A small amount of blood (about 1-2 tablespoons) will be drawn with a needle to test for antibodies
(helps the body fight off germs) to flu. Some of the blood may be taken for routine care and some will be taken for research. The blood will be drawn through your child's central line if they have one, if not it will be by getting blood from the vein directly. A second blood draw may be needed if your child is getting IVIG/SCIG.  
If flu season has started, a nose swab will be done to test for flu.  
Once the study doctor has made sure it is OK for your child to be vaccinated the second time, he/she will be given either Fluzone Quadrivalent® or Fluzone HD®. The vaccine that he/she gets will be the same (Fluzone Quadrivalent® or Fluzone HD®) as they received the first time. A nurse will then give your child the vaccine by injecting it with a needle into his or her arm. The study staff will watch your child for at **least 15 minutes** after getting the vaccine.  
You will be asked to take your child's temperature once every day, at about the same time every day (in the evening). You will be given a memory aid worksheet. This is where you should write down your child's temperature and any symptoms or illnesses that he/she has. Also, write down any new medicine taken and all extra doctor visits. This starts the day that he/she receives the study vaccine and every day for the next week. Telephone and/or electronic communication **(Day 1-3 and 8-10 after second vaccine)** A study team member will attempt to contact you by phone, text, or email. The following will be done:
- You will be asked about your child's health.  
- We will collect the information on the memory aid worksheet. - We will answer any questions you might have.  
Save the memory aid worksheet, you may need to bring it in at the next visit or mail it in a provided addressed and stamped envelope after completion. You can also take a picture of the memory aid and send it to the team.

You will be asked to come back to the clinic once 4-6 weeks later after visit 2. This is what will be done:
We will collect the memory aid worksheet if you haven't already returned it. You will be asked about any changes in medicines that your child is taking.  
If flu season has started, a nose swab will be done to test for flu. You will be asked about your child's health. A small about of blood (about 1-2 tablespoons) will be taken from your child's central line if they have one, if not it will be by getting blood from the vein directly to test for new antibodies to flu. Some of the blood may be taken for routine care and some will be taken for research. A second blood draw may be needed if your child is getting IVIG/SCIG.  
If your child will not be able to return for visit 3, study staff will arrange for a blood draw to be done locally and shipped to test for antibodies to flu. You will be called and asked about your child's health and any changes in medicines that he/she is taking. We will also ask you to swab your child's nose and mail the swab to the research team.

- You will be asked to bring your child back to the clinic at about 6 months after visit 2… - This is what will be done:
o A small amount of blood (about 1-2 tablespoons) will be taken from your central line if you have one, if not it will be by getting blood from the vein directly to test for antibodies to flu.  
o If flu season has started, a nose swab will be done to test for flu.  
OPTIONAL: Your child has the option of coming back 5-10 days (about one week) after each vaccine for a blood draw only. This is to test for how different cells of your child's immune system fights against flu.
Clinical trial: NCT02860039
Section: Withdrawal from Study
Subsections: 10. Reasons Why The Study Doctor May Take Your Child Out Of This **Study:**

The study doctor may decide that it is best for your child to leave the study. If he/she is taken out of the study for any reason, you will be told why. If the study doctor takes your child out of the study, he/she will be followed for safety, including the follow-up telephone and/or electronic communication, unless you withdraw consent for follow-up. 11. What will happen if you decide to stop your child from being in this **study?**
Joining the study is voluntary (that is, you decide). If your child joins the study, you have the right to stop the study at any time and for any reason. You should tell your study doctor or nurse right away. Deciding to not be part of the study will not change your child's regular medical care in any way. If you/your child decide to leave the study, we will ask to follow him/her for safety, including the follow-up telephone calls.