A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and A… (NCT07596199) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
95 participantsStarted 2026-06-29
Plain-language summary
The purpose of this Phase 3, non-randomized, single-arm, open-label study is to evaluate the immune response, reactogenicity and safety of GSKs dTpa vaccine in Japanese pregnant women between 27 weeks and less than 37 weeks of pregnancy. Both the pregnant women and their neonates born during the study will be evaluated for specific analyses.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
. Participants and Legally acceptable representative(s) \[LAR(s)\] who give physical or digital informed consent after the study has been explained according to local regulatory requirements, and before any study-specific procedures are performed. The informed consent given at screening should include consent for both the maternal participant's participation and participation of the infant after the infant's birth.
. Healthy participants as established by medical history and clinical examination at screening.
. Participants between and including 18 and 45 years of age at the time of the study intervention administration (Visit 1/Day 1).
. Pre-pregnancy body mass index (BMI) (based on participant's report) between 17.0 and 39.9 kg/m\^2, inclusive.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of seropositive healthy pregnant women for anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Timeframe: At Month 1 post-vaccination
2
Number of seropositive participants for anti-PT, anti-FHA and anti-PRN antibodies from samples in cord blood sample at birth
. Pregnant female at 27,0/7 to 36,6/7 weeks of gestation (completed week 27 but not week 37) at the time of vaccination (Visit 1/Day 1), as established or confirmed by ultrasound examination.
. No significant fetal abnormalities, as observed by the fetal morphological abnormality screening test conducted after 18 weeks of gestation and the most recent ultrasound testing (no more than 6 weeks before enrollment).
. Nuchal translucency scan, serum testing and any other prenatal tests, if conducted, should suggest normal pregnancy.
Exclusion criteria
. Participants diagnosed with multiple pregnancies.
. Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes such as;
. Acute or unstable chronic conditions, chronic clinically significant abnormality, poorly controlled pre-existent co-morbidities or any other clinical conditions, as determined by physical examination and/or laboratory tests.
. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
. Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.
. Condition that in the judgment of the investigator would make intramuscular injection unsafe.
. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant and/or to the unborn infant due to participation in the clinical study.
. Prior major congenital anomalies or early onset (\<34 weeks of gestation) of eclampsia/pre-eclampsia in previous pregnancy, or stillbirth or neonatal death, or multiple (\>=2) spontaneous abortions, or pre-term delivery (\<=34 weeks gestation) or having ongoing intervention (medical/surgical) in current pregnancy to prevent pre-term delivery.