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Tests treatment safety and results for Diphtheria-Tetanus-acellular Pertussis Vaccines
Official title A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
ClinicalTrials.gov ID: NCT07596199
What this study is testing
What is dTpa?
dTpa is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for diphtheria-tetanus-acellular pertussis vaccines.
Also referred to as Boostrix.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- Medical conditions:
- 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...
- Gestational hypertension (defined as systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg) at \>=20 weeks of gestation in a...
- Hemodynamically significant cardiac disorders (previously corrected patent ductus arteriosis is allowed).
- Gestational diabetes which is not controlled by medication, diet and/or exercise as determined by glucose challenge/tolerance test conducted after 20...
See the full eligibility criteria
Who can join
- 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...
- 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.
- 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.
- Participants who are willing to provide cord blood and/or infant blood.
- Participants who are willing to have them and their newborns followed-up until 1 month post-delivery.
- Participants who do not plan to give their child for adoption.
- Japanese ethnic origin.
What rules you out
- Medical conditions:
- 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;
- Gestational hypertension (defined as systolic blood pressure \>=140 mmHg and/or diastolic blood pressure \>=90 mmHg) at \>=20 weeks of gestation in a woman with a previously normal blood pressure. Women with gestational...
- Hemodynamically significant cardiac disorders (previously corrected patent ductus arteriosis is allowed).
- Gestational diabetes which is not controlled by medication, diet and/or exercise as determined by glucose challenge/tolerance test conducted after 20 weeks of gestation or as per local recommendations of the country...
- Any other conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes
- 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...
- 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 (\ =2) spontaneous abortions, or pre-term delivery (\<=34 weeks gestation) or having ongoing intervention (medical/surgical) in current pregnancy to prevent pre-term...
- Family history (first degree relatives only) of congenital anomalies, recurrent pregnancy losses (two or more consecutive losses) and unexplained neonatal death(s) in the participant.
- History of an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine.
- History of transient thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive episodes) following an earlier immunisation against diphtheria and/or tetanus.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus or pertussis...
- History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years.
- Lymphoproliferative disorder or malignancy within 5 years before the study dose administration (excluding effectively treated non melanoma skin cancer). Prior/Concomitant therapy:
- Previous vaccination containing diphtheria, tetanus or pertussis antigens, or diphtheria and tetanus toxoids at any time during the current pregnancy and within 5 years from study participation.
- Use of any investigational or non-registered product other than the study intervention(s) during the current pregnancy or their planned use during the study period.
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments or planned administration through delivery.
- Up to 6 months prior to the study intervention administration: For corticosteroids, this will mean prednisone equivalent \>=20 mg/day for adult participants. Inhaled, intra-articular/intra-bursal and topical steroids...
- Up to 6 months prior to the study intervention administration: long-acting immune-modifying drugs including among others immunotherapy monoclonal antibodies, antitumoral medication.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and planned administration through delivery (Visit 3/Day of delivery), except:
- Seasonal influenza vaccines, RSV vaccines, Hepatitis B vaccines, and SARS-CoV-2, all of which may be administered according to standard of care \>=14 days before or after study vaccination.
- Administration of immunoglobulins or other blood products or plasma derivatives during the period starting 3 months before the study intervention or planned administration through delivery with the exception of anti-D...
- Planned administration of any prophylactic medication (e.g., analgesics, antipyretics) in the absence of any symptom and in anticipation of a reaction to the study intervention administration. Prior/Concurrent clinical...
- Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention...
- History of chronic alcohol consumption and/or drug abuse, based on investigator's judgment.
- Any study personnel or their immediate dependents, family, or household members.
The study team makes the final eligibility decision.
Where it's taking place
- Chiba, Japan
- Fukui, Japan
- Fukushima, Japan
- Hokkaido, Japan
- Kanagawa, Japan
- Kyoto, Japan
- Osaka, Japan
- Saitama, Japan
- Shizuoka, Japan
- Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chiba, Japan; Fukui, Japan; Fukushima, Japan; Hokkaido, Japan; Kanagawa, Japan; Kyoto, Japan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.