About Clinical Research
Study #36721-Study is Full

• Women of child bearing potential (WOCBP) must agree to use a highly effective contraception method consistently and correctly according to the methods listed at least 1 month prior to vaccination and agree to continue
contraception during the entire treatment period and for 3 months after completion of the study:
o Combined estrogen and progestogen
 Oral
 Intravaginal
 Transdermal
o Progestogen only
 Injectable
o IUD
o IUS
o Bilateral Tubal occlusion
o Vasectomized partner – provided that the partner is the sole male sexual partner and the absence of sperm has been confirmed.
o Abstinence
• Postmenopausal – no menses for 12 months without an alternative medical cause
• Females on a hormone replacement therapy and whose menopausal status is in doubt will be required to us a non-hormonal, highly effective contraception method if they wish to continue their hormone replacement therapy
during the study, Otherwise, they must discontinue hormone replacement therapy to all confirmation of postmenopausal status before study enrollment.
• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (completion of the e-diary and return for follow up visits)
• Written informed consent obtained from the participant prior to performance of any study-specific procedure.
• Participants should be advised to take appropriate infection control measures to prevent becoming infected with SARS-CoV2 during the study.
• Healthy participants as established by medical history and clinical examination before entering the study.

• Additional inclusion criteria for Epoch 2:
• Participation in Epoch 1 of the study with receipt of 2 or 3 doses of study intervention.
• Participants who can and will comply with the requirements of the protocol Participants with active infections, including COVID-19 may be rescheduled within the window period, if they no longer have signs or symptoms of
active infection in the judgment of the investigator.