The Safety of Boostrix Following Routine Immunization of Pregnant Women

The incidence rate (per 1000) of adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The pre-specified infant adverse event assessed was small for gestational age.

Time frame: From birth through 6 months of age

Population: The analysis was performed on live singleton infants for whom the event could be assessed and who born to women from Exposed cohort women-on or after 1st day of 27th week of pregnancy group and Unexposed historical cohort women group, who met eligibility criteria.

Incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse event assessed was preterm delivery.

Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Population: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed.

The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The pre-specified maternal adverse events assessed were pre-eclampsia and eclampsia; Intra-uterine infections.

Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Population: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed.

The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The adverse events of this analysis include adverse events presented in the above outcomes, among the infants whose mothers were vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these infant adverse events was descriptive. The infant adverse events assessed were: small for gestational age; neonatal death; congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.

Time frame: From birth through 6 months of age

Population: The analysis was performed on infants for whom the specified event could be assessed, who were born to women from Exposed cohort women-before 1st day of 27th week of pregnancy group, and who met the eligibility criteria. Incidence rate of neonatal death; clefts; congenital anomalies of: nervous system, respiratory system; lower gastrointestinal system, limb, or other and unspecified congenital anomalies was not calculated for the analyzed group as none were reported in this group.

The incidence rate (per 1000) of other infant adverse events was calculated as the total number of adverse events in the numerator and the total of persons at risk in the denominator. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other infant adverse events assessed were neonatal death, congenital anomalies of: nervous system; eye; ear, face, or neck; cardiovascular system; respiratory system; clefts; upper gastrointestinal system; lower gastrointestinal system; genital organs; renal system; musculoskeletal system; limb; integument; other and unspecified.

Time frame: From birth through 6 months of age

Population: The analysis was performed on live singleton infants for whom the specified event could be assessed, and who born to women from Exposed cohort women-on or after 1st day of 27th week of pregnancy group and Unexposed historical cohort women group, who met the eligibility criteria.

The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; transfusion during delivery hospitalization.

Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Population: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of stillbirth/fetal death with congenital anomalies was not calculated for Exposed Cohort women-on or After 1st Day of 27th Week of Pregnancy and Unexposed Historical Cohort Women Groups as none were reported in these groups.

The incidence rate (per 1000) consisted of the total number of adverse events in the numerator and the number of persons at risk in the denominator. The adverse events of this analysis include the adverse events presented in the above outcomes as well as spontaneous and therapeutic abortion with or without congenital anomalies in pregnant women vaccinated with Boostrix before the 27th week of gestation. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were stillbirth/fetal death; stillbirth/fetal death with congenital anomalies; spontaneous abortion; spontaneous abortion with congenital anomalies; therapeutic abortion; therapeutic abortion with congenital anomalies; transfusion during delivery hospitalization; preterm delivery.

Time frame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks

Population: The analysis was performed on women from Exposed cohort women-before 1st day of 27th week of pregnancy group who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of stillbirth/fetal death, stillbirth/fetal death with congenital anomalies, spontaneous abortion with congenital anomalies, therapeutic abortion, or therapeutic abortion with congenital anomalies was not calculated for the analyzed group as none were reported in this group.

The incidence rate (per 1000) of other maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The analysis was used for hypothesis generation/signal detection, hence without adjustment for multiple comparisons. The other maternal adverse events assessed were poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.

Time frame: From date of Boostrix vaccination (Exposed cohort women-on or after 1st day of 27th week of pregnancy) or from an index date (Unexposed historical cohort women) until end of enrollment or pregnancy, whichever came first, up to 13 weeks

Population: The analysis was performed on all women from the Exposed cohort women-on or after 1st day of 27th week of pregnancy group and the Unexposed historical cohort women group, who met the eligibility criteria and for whom the event could be assessed. Incidence rate of maternal death was not calculated for Unexposed Historical Cohort Women Group as none were reported in this group.

The incidence rate (per 1000) was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Due to the small sample size, the analysis of these women adverse events was descriptive. The women adverse events assessed were pre-eclampsia and eclampsia; intra-uterine infections; poor fetal growth; placental abruption; preterm pre-labor rupture of membranes; maternal death.

Time frame: For the Exposed cohort women-before 1st day of 27th week of pregnancy: from date of Boostrix vaccination until end of enrollment or pregnancy, whichever came first, up to 40 weeks

Population: The analysis was performed on women from Exposed cohort women-before 1st day of 27th week of pregnancy group who met the eligibility criteria and for whom the specified event could be assessed. Incidence rate of placental abruption and maternal death was not calculated for Exposed Cohort Women-before 1st Day of 27th Week of Pregnancy Group as none were reported in this group.