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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • dTpa

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators