A Phase II, randomised, single-blind, platform trial to assess safety, reactogenicity and immunogenicity of COVID-19 vaccines in pregnant women in the United Kingdom

St George's, University of London0 sites319 target enrollmentOctober 14, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 14, 2021

End Date

October 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

Female

Sponsor

•1\. Healthy women \=18 years of age who are between 13 0/7 and 34 0/7 weeks’ gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for obstetric complications
•2\. Able and willing (in the investigator’s opinion) to comply with all study requirements
•3\. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures
•4\. Willing and able to give informed consent prior to study enrolment
•5\. No contraindication to the specific vaccine to be administered in the study, according to the Green Book

•1\. Previous microbiological (based on a positive SARS\-CoV\-2 NAAT result) diagnosis of COVID\-19
•2\. Administration of immunoglobulins and/or any blood products within the 3 months preceding the planned administration of the study vaccine candidate (with the exception of anti\-D immunoglobulin)
•3\. Previous vaccination with any COVID\-19 vaccine (main cohort); prior receipt of one dose of a COVID\-19 vaccine is permitted (sub\-study)
•4\. Any confirmed or suspected immunosuppressive or immunodeficient state; chronic administration (defined as more than 14 continuous days) of immunosuppressant medication within the past 3 months, except topical steroids or short\-term oral steroids (course lasting \=14 days)
•5\. Any contraindication to the specific vaccine to be administered in the study, according to the Green Book or to the Summary of Product Characteristics for a specific vaccine
•6\. Current major illness of the mother or conditions of the fetus that, in the investigator’s judgment, will substantially increase the risk associated with the participant’s participation in, and completion of, the study or could preclude the evaluation of the participant’s response, including but not limited to the following:
•6\.1\. Uncontrolled gestational hypertension
•6\.2\. Preeclampsia\-eclampsia
•6\.3\. Placental abnormality
•6\.4\. Polyhydramnios or oligohydramnios