Study design and participants
diphtheria, ICH, tetanus
DIPHTHERIA, TETANUS, RECRUITMENT
The design of this phase 2, dual-site trial was based on a previous randomized observer-blind trial involving 250 women of childbearing age (50 participants per vaccine group) Study design. Pregnant women were given one dose of study vaccine between ≥20 weeks and <33 weeks gestational age. Local and systemic reactions were collected within 7 days after vaccination. The safety assessment was performed by active follow-up until Visit 4 (2 months after delivery) and by passive follow-up until Visit 10 (13 months after delivery). The blood sample collection for immunogenicity assessment was performed at Visit 1 (before vaccination), Visit 2 (28 days after vaccination) and Visit 3 (delivery). The growth and development assessment and safety assessment for infants were performed at Visit 3 (delivery) until Visit 10 (13 months of infant age). Infants received DTwP-Hib-HB vaccine at 2, 4 and 6 months of age and Pneumococcal 13-valent conjugate vaccine (PCV) at 2, 4 and 12 months of age as primary infant immunization. The cord blood sample at delivery and infant blood sample at Visit 4 (2 months of age), Visit 6 (5 months of age), Visit 8 (7 months of age) and Visit 10 (13 months of age) were collected for immunogenicity assessment.Healthy pregnant women, 18 to 40 years old with no underlying chronic medical conditions, and an uncomplicated singleton pregnancy at ≥20 weeks and <33 weeks gestational age as confirmed by ultrasound were invited to participate. Women who had previously received diphtheria or tetanus or pertussis-containing vaccine within 1 year prior to enrolment were excluded (complete inclusion/exclusion criteria in The trial was conducted according to the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP), the Declaration of Helsinki, and local ethical guidelines. Ethical approval was obtained from the Institutional Review Boards of the Faculty of Medicine Siriraj Hospital at Mahidol University, Faculty of Medicine at Chulalongkorn University, Bangkok, Thailand and Western Institutional Review Board (now known as WIRB-Copernicus Group), Washington, USA. Written informed consent was obtained from all participants before recruitment into the study.