ICON Early Phase Services is conducting a research study for healthy adults ages 18-55. This study is being done to test the effectiveness of an inactivated flu vaccine when exposed to another drug.
Vital signs, ECGs, physical examinations and pregnancy, drug and alcohol screens will be performed. Blood and urine samples will also be obtained during this study.
Participants will complete:
- 1 screening visit
- 3 consecutive overnights
- 8 outpatient visits
To determine if you fully qualify, it will be necessary to obtain blood samples after an 8- hour fast. You have the option of fasting for the screening appointment, or, you may return at a later date. If ICON does not have your medical records on file, you will need to provide medical records at screening.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy adult, meaning no significant medical conditions
- I am between 18 and 55 (inclusive) years old
- My BMI is between 18.0 and 32.0 kg/m2 (inclusive) and I weigh at least 99 lbs.
- I agree not to smoke for the duration of the study and to abide by the rules of the clinic, which is a non-smoking facility.
- I am willing to abstain from alcohol, tobacco, and caffeine-containing products prior to admission and during the in-clinic stay
- I have not received any investigational drug or experimental procedure within 90 days prior to first dose
- I have not received a vaccine of any within the last year
- I have not received a flu vaccine within the last two years
*Antibody titer test will be done.
- I have not had a previous reaction or hypersensitivity to the flu vaccine
- I do not have any flu-like symptoms
- If Female, I am not pregnant or breastfeeding and I do not plan to become pregnant during the study
- If Female and capable of becoming pregnant, I agree to use a highly effective method of birth control during the study and for a period of 20 weeks after the last dose. Methods of birth control include:
- Combined (estrogen- and progesterone-containing) hormonal contraception (oral, implant, injectable) for at least 30 days. If taken orally, an additional barrier method will be required.
- Progesterone releasing intrauterine systems of the Copper T 380A intrauterine device
- Vasectomized partner
- Heterosexual abstinence if this is the preferred and usual lifestyle
- If Female and not capable of becoming pregnant, I have been postmenopausal for at least 1 year or I am surgically sterile (tubes tied, uterus removed, tubes removed) or I was born sterile.
- If Male and I have a partner capable of becoming pregnant, I agree to use a condom
- If Male and I have a partner capable of becoming pregnant, we are not planning a pregnancy during the study
- If Male and I have a partner capable of becoming pregnant, my partner must be willing to use a form of contraception as described above
- I am able to communicate effectively in English with the study personnel
- I do not have a history of drug allergy
- I have not recent donated blood or blood products
- I do not have a history of hypersensitivity to the flu vaccine
- I do not have a history of gastrointestinal disease
- I do not have any heart disease
- I have not recently had an infection or serious infection (e.g., requiring hospitalization)
- I have not had cancer within the past 5 years (except for skin cancer or cancer in situ)
- I do not have a recent history of alcoholism or drug/chemical abuse
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
To determine if you fully qualify, it will be necessary to obtain blood and urine samples after an 8-hour fast. You have the option of fasting for a blood or urine sample at the screening appointment, or, you may return at a later date for us to obtain these samples.
If you fast, you should refrain from eating or drinking anything (with the exception of water) for 8 hours before your appointment. We will be testing for tobacco use and drug abuse. Please refrain from consuming alcohol at least 24 hours prior to your screening appointment.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, military ID or passport. You will be required to show this same photo ID at all study visits.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.
Be advised that you may need to provide medical records as part of the screening process for this study. If possible, please bring your full medical records with you to your screening appointment. If you cannot bring your records with you, you must provide them before you can admit to the study.