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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
95
1 dose of dTpa vaccine is administered intramuscularly.
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).
Time frame: 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
Time frame: On the Day of birth
Booster response to pertussis (PT, FHA and PRN) antigens in healthy pregnant women
Booster response to PT, FHA and PRN antigens is defined as: for participants with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration \>=4 times the assay cut-off; for participants with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration \>= 4 times the pre-vaccination antibody concentration; for participants with pre-vaccination antibody concentration \>=4 times the assay cut-off, post-vaccination antibody concentration \>=2 times the pre-vaccination antibody concentration.
Time frame: At Month 1
Antibody concentration for antibodies against pertussis (PT, FHA, PRN) in healthy pregnant women
Time frame: 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
Time frame: 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
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Seroprotection is defined as antibody concentrations (anti-diphtheria and anti-tetanus) are greater than or equal to 0.1 IU/mL by ELISA test.
Time frame: 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
Time frame: On the Day of birth
Antibody concentration for anti-diphtheria and anti-tetanus antibodies in cord blood of the neonates born to mothers that received dTpa vaccine during pregnancy
Time frame: On the Day of birth
Number of seroprotected neonates for anti-diphtheria and anti-tetanus antibodies, from samples in cord blood
Time frame: On the Day of birth
Number of healthy pregnant women with solicited administration site adverse events
The assessed events are pain, redness and swelling.
Time frame: From Day 1 (day of vaccination) to Day 7 post-vaccination
Number of healthy pregnant women with solicited systemic adverse events (AEs)
The assessed events are arthralgia, gastrointestinal symptoms, fatigue, fever, headache and myalgia. Fever is defined as temperature \>=37.5 degrees Celsius.
Time frame: From Day 1 (day of vaccination) to Day 7 post-vaccination
Number of healthy pregnant women with unsolicited adverse events
An unsolicited AE is an AE that was either not included in the list of solicited AEs or could be included in the list of solicited AEs but with an onset outside the specified period of follow-up for solicited AEs. Unsolicited AEs include both serious and non-serious AEs.
Time frame: From Day 1 (day of vaccination) to Day 30 post-vaccination
Number of healthy pregnant women with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, is a suspected transmission of any infectious agent via an authorized medicinal product, or other situations as per investigator's judgment.
Time frame: From Day 1 (day of vaccination) and up to 1-month post-delivery (study end)
Number of healthy pregnant women with AEs and SAEs leading to study withdrawal
Time frame: From the Day 1 (day of vaccination) and up to 1-month post-delivery (study end)
Number of healthy pregnant women with pregnancy outcomes at delivery
The assessed pregnancy outcomes are: live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies, elective termination with congenital anomalies.
Time frame: On the Day of delivery
Number of healthy pregnant women with pregnancy-related AEs
The assessed pregnancy-related AEs are (but not limited to): gestational diabetes, pregnancy-related hypertension, pre-eclampsia, eclampsia, premature rupture of membranes, preterm premature rupture of membranes, premature labor, threatened premature labor, fetal growth restriction, obstetrical hemorrhage, maternal death.
Time frame: From Day 1 (day of vaccination) and up to 1-month post-delivery
Number of neonates, born to mothers that received dTpa vaccine during pregnancy, with neonatal AEs
The assessed neonatal AEs are (but not limited to): preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischemic encephalopathy, failure to thrive/growth deficiency.
Time frame: From the Day of birth and up to 1-month post-birth
Number of neonates, born to mothers that received dTpa vaccine during pregnancy, participants with SAEs
Time frame: From the Day of birth and up to 1-month post-birth
Number of neonates, born to mothers that received dTpa vaccine during pregnancy, with AEs and SAEs leading to study withdrawal
Time frame: From the Day of birth and up to 1-month post-birth