A Phase I Study In Healthy Adults To Assess The Safety And Immunogenicity Of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
• Adult males and non-pregnant, non-breastfeeding females between 20 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, for safety considerations, and because of the need for isolation.
• Are in good health, as determined by medical history and targeted physical examination to ensure any existing medical diagnoses or conditions (except those exclusionary) are stable. More information on this criterion can be found in the protocol.
• Agree to storage of blood specimens for future research.
• Available for the duration of the trial. Subjects must be willing and able to remain within the Isolation Unit for the specified duration of confinement.
• Provide written informed consent prior to initiation of any study procedures, including future use of specimens.
• Female subjects of childbearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). All female subjects will be considered being of childbearing potential except those who have undergone hysterectomy or tubal ligation and those in whom menopause occurred at least 1 year prior to the study.
• Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study.
• Oral temperature is less than 100.4°F.
• Pulse is 50 to 115 bpm, inclusive.
• Systolic blood pressure is 85 to 150 mm Hg, inclusive.
• Diastolic blood pressure is 55 to 95 mm Hg, inclusive.
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.