Passive protection against pertussis in early infancy following maternal immunisation during pregnan
Conditions
Interventions
Sponsors
Ogawa Masayuki
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. 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. 3. Healthy participants as established by medical history and clinical examination at screening. 4. Participants between and including 18 and 45 years of age at the time of the study intervention administration (Visit 1/Day 1). 5. Pre-pregnancy body mass index (BMI) (based on participant's report) between 17.0 and 39.9 kg/m2, inclusive. 6. Pregnant female at 270/7 to 366/7 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. 7. 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). 8. Nuchal translucency scan, serum testing and any other prenatal tests, if conducted, should suggest normal pregnancy. 9. Participants who are willing to provide cord blood and/or infant blood. 10. Participants who are willing to have them and their newborns followed-up until 1 month post-delivery. 11. Participants who do not plan to give their child for adoption. 12. Japanese ethnic origin.
Exclusion criteria
Exclusion criteria: 1. Participants diagnosed with multiple pregnancies. 2. 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 (=2) spontaneous abortions, or pre-term delivery (<=34 weeks gestation) or having ongoing intervention (medical/surgical) in current pregnancy to prevent pre-term delivery. 9. 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. 10. History of an encephalopathy of unknown etiology, occurring within 7 days following previous vaccination with pertussis-containing vaccine. 11. History of transient thrombocytopenia or neurological complications (for convulsions or hypotonic-hyporesponsive episodes) following an earlier immunisation against diphtheria and/or tetanus. 12. 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 vaccines. 13. History of physician-diagnosed or laboratory-confirmed pertussis within the past 5 years. 14. Lymphoproliferative disorder or malignancy within 5 years before the study dose administration (excluding effectively treated non melanoma skin cancer). 15. Previous vaccination containing diphtheria, tetanus or pertussis antigens, or diphthe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Seropositivity status for anti- PT, anti-FHA and anti-PRN, 1 month after vaccination -Seropositivity status for anti- PT, anti- FHA and anti-PRN in cord blood sample at birth | — |
Secondary
| Measure | Time frame |
|---|---|
| -Booster response to pertussis (PT, FHA and PRN) antigens, 1 month after vaccination. -Antibody concentration for antibodies against pertussis (PT, FHA and PRN), at Day 1 and 1 month after vaccination. -Antibody concentration and seroprotection status for antibodies against diphtheria and tetanus at Day 1 and 1 month after vaccination. -Antibody concentration for antibodies against pertussis (PT, FHA and PRN) in cord blood sample at birth. -Antibody concentration and seroprotection status for antibodies against diphtheria and tetanus in cord blood sample at birth. -Occurrence of each solicited local and systemic AEs within 7 days post-vaccination (i.e., the day of vaccination and 6 subsequent days). -Occurrence of unsolicited AEs within 30 days post-vaccination (i.e., the day of vaccination and 29 subsequent days) -Occurrence of all SAEs, (S)AEs leading to study withdrawal from the vaccination up to 1 month post-delivery. -Occurrence of pregnancy outcome at birth -Occurrence of pregnancy-related AEs from Day 1 until 1 month post-delivery -Occurrence of neonatal AEs up to 1 month post-delivery -Occurrence of SAEs, (S)AEs leading to study withdrawal up to 1 month post-delivery. | — |
Contacts
Public ContactMasayuki Ogawa
GlaxoSmithKline K.K.
Outcome results
None listed