Common use of Inclusion Criteria Clause in Contracts

Inclusion Criteria. Participants must meet all of the following criteria at the time of randomisation: 1. Healthy male or female adults aged 18 years and over 2. Receipt of a standard-dose licensed influenza QIV vaccine on the day of, or within 28 days prior to, randomisation 3. A female participant is eligible for this study if she is not pregnant or breast feeding and one of the following: a. Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year) b. Of childbearing potential but agrees to practice effective contraception 8 weeks post-vaccination and has a negative urine pregnancy test pre-vaccination. Acceptable methods of contraception include one or more of the following: i. Male partner who is sterile prior to the female participant’s entry into the study and is the sole sexual partner for the female participant ii. Implants of levonorgestrel

Appears in 2 contracts

Sources: Principal Investigator Agreement, Principal Investigator Agreement