Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women (NCT05808166) | Clinical Trial Compass
RecruitingPhase 2
Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women
Pakistan2,358 participantsStarted 2024-05-02
Plain-language summary
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.
Who can participate
Age range16 Years – 45 Years
SexFEMALE
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Inclusion criteria
âś“. 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.
âś“. Individual willing to provide written informed consent for herself and her infant to participate in the study.
âś“. Individual who can be followed up during the study period and can comply with the study requirements.
âś“. 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.
âś“. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
âś“. Healthy women 16-45 years of age.
âś“. Individual willing to provide written informed consent to participate in the study.
âś“. Individual who can be followed up during the study period and can comply with the study requirements.
Exclusion criteria
âś•. Has received any hepatitis E vaccine in the past.
✕. Febrile illness (axillary temperature ≥ 38.5°C) or acute illness within 3 days prior to the study vaccination.
What they're measuring
1
Proportion of pregnancy-related AESI and SAE from vaccination in pregnant participant.
Timeframe: Throughout the study period, approximately 24 months.
2
Immunogenicity in pregnant and non-pregnant participants
. Known history or allergy to study vaccine components and/or excipients or other medications, or any other allergies or medical history deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial (e.g., Guillain-Barre Syndrome).
âś•. Major congenital abnormalities which in the opinion of investigator may affect the participant's participation in the study.
âś•. Known history of immune function disorders including immunodeficiency diseases (known HIV infection or other immune function disorders) and lupus.
âś•. Chronic use of systemic steroids (\>2 mg/kg/day or \>20 mg/day prednisone equivalent for periods exceeding 10 days), cytotoxic or other immunosuppressive drugs within past 6 weeks.
âś•. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives.
âś•. Behavioral or cognitive impairment, or chronic substance abuse, or psychiatric disease or neural disorders, that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial.