A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women

NCT07596199 | Recruiting Phase 3

• 1 other identifier: 308736
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Keywords

Diphtheria; tetanus and acellular pertussis (dTpa) vaccine; Pregnant women; Neonates; Immune response; Reactogenicity; Safety

Outcome Measures

Primary Outcomes (2)

• Number of seropositive healthy pregnant women for anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

  Seropositivity is defined as antibody concentrations (anti-PT, anti-FHA and anti-PRN) are greater than or equal to the assessed assay cut-offs. The considered cut-off values are: anti-PT: 2.693 International Units per milliliter (IU/mL), anti-FHA: 2.046 IU/mL, anti-PRN: 2.187 IU/mL, as measured by Enzyme-Linked Immunosorbent assay (ELISA).

  At Month 1 post-vaccination

• Number of seropositive participants for anti-PT, anti-FHA and anti-PRN antibodies from samples in cord blood sample at birth

  On the Day of birth

Secondary Outcomes (17)

• Booster response to pertussis (PT, FHA and PRN) antigens in healthy pregnant women

  At Month 1

• Antibody concentration for antibodies against pertussis (PT, FHA, PRN) in healthy pregnant women

  On Day 1 (day of vaccination) and at Month 1 post-vaccination

• Antibody concentration for anti-diphtheria and anti-tetanus antibodies in healthy pregnant women

  On Day 1 (day of vaccination) and at Month 1 post-vaccination

• Number of seroprotected healthy pregnant women for anti-diphtheria and anti-tetanus antibodies

  On Day 1 (day of vaccination) and at Month 1 post-vaccination

• Antibody concentration for antibodies against pertussis (PT, FHA, PRN) in the cord blood of the neonates born to mothers that received dTpa vaccine during pregnancy

  On the Day of birth

Study Arms (1)

dTpa Group

EXPERIMENTAL

Healthy pregnant women at 27 to 36 weeks of gestation receive one dose of the investigational dTpa vaccine at Day 1 (representing the day of vaccination).

Biological: dTpa

Interventions

dTpa BIOLOGICAL

1 dose of dTpa vaccine is administered intramuscularly.

Also known as: Boostrix

dTpa Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify 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 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.
• 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.

You may not qualify 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 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 hypertension who maintain blood pressure in the normal range (\<140 mmHg and \<90 mmHg) through diet and/or on antihypertensive medications would be eligible except for eclampsia/pre-eclampsia.
• 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 (Gestational diabetes is defined as absence of pre-gestational diabetes and hyperglycemia during pregnancy, which is not due to other known causes).
• 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 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (18)

GSK Investigational Site

Chiba, 279-0001, Japan

RECRUITING

GSK Investigational Site

Chiba, 286-8520, Japan

RECRUITING

GSK Investigational Site

Fukui, 910-0833, Japan

RECRUITING

GSK Investigational Site

Fukuoka, 820-8505, Japan

RECRUITING

GSK Investigational Site

Fukushima, 965-8585, Japan

RECRUITING

GSK Investigational Site

Hokkaido, 085-8512, Japan

RECRUITING

GSK Investigational Site

Kanagawa, 236-0004, Japan

RECRUITING

GSK Investigational Site

Kyoto, 604-8845, Japan

RECRUITING

GSK Investigational Site

Nagano, 390-8601, Japan

RECRUITING

GSK Investigational Site

Osaka, 556-0005, Japan

RECRUITING

GSK Investigational Site

Osaka, 583-8588, Japan

RECRUITING

GSK Investigational Site

Saitama, 330-0855, Japan

RECRUITING

GSK Investigational Site

Saitama, 336-8522, Japan

RECRUITING

GSK Investigational Site

Shizuoka, 420-8527, Japan

RECRUITING

GSK Investigational Site

Shizuoka, 424-8636, Japan

RECRUITING

GSK Investigational Site

Tokyo, 113-8519, Japan

RECRUITING

GSK Investigational Site

Tokyo, 152-8902, Japan

RECRUITING

GSK Investigational Site

Tokyo, 162-8655, Japan

RECRUITING

MeSH Terms

Conditions

Diphtheria; Tetanus

Interventions

Pentetic Acid; Boostrix

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, single-arm, open-label

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

Locations

JP (18)