A Phase II, Randomized, Observer-blinded, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women Between Gestational Age 14-34 Weeks and Non-Pregnant Women of 16-45 Years Old.
This is a phase II randomized, observer-blinded, placebo-controlled study with 3 arms enrolling a total of 2,358 participants. The arms are composed of Arm 1, pregnant participants receiving Hecolin® (N=1,104) with immunogenicity subset (n=150), Arm 2, pregnant participants receiving placebo (N=1,104) with immunogenicity subset (n=150), and Arm 3, non-pregnant participants receiving Hecolin® (N=150) of which all participants in this arm will be included in the immunogenicity subset.
⁃ In order to be eligible to participate in this study, a pregnant/non-pregnant woman must meet all of the following criteria:
⁃ Pregnant women only:
• Healthy women 16-45 years of age who are between 14 0/7 and 34 6/7 weeks gestation1 on the day of planned vaccination with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications for herself and her infant.
• Individual willing to provide written informed consent for herself and her infant to participate in the study.
• Individual who can be followed up during the study period and can comply with the study requirements.
• Individual and fetus in good health as determined by the outcome of medical history, physical examination, obstetric history, prenatal care (by ultrasound and other prenatal assessment subject to gestational age), vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.
• Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
⁃ Non-pregnant women only:
• Healthy women 16-45 years of age.
• Individual willing to provide written informed consent to participate in the study.
• Individual who can be followed up during the study period and can comply with the study requirements.
• Individual in good health as determined by the outcome of medical history, physical examination, vital signs, laboratory evaluations at screening and the clinical judgment of the investigator.
• Individuals who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Females of childbearing potential with negative urinary pregnancy test on the day of screening.
• Females of childbearing potential who are using an effective birth control method2 for at least 4 weeks before the screening and up to 4 weeks after the last vaccination.