Background
Methods
Search strategy and selection criteria
Data extraction
Assessment of risk of bias and quality of evidence
Statistical analysis
Results
Search results
a.) Studies addressing safety outcomes | ||||||||
Authors and country | Setting/data sources | Study design/ period | Inclusion (I) and exclusion (E) criteria | Intervention/comparison | Final N/ N potentially eligible/ (%) | N Inter-vention group | N Control group | Outcomes |
Munoz et al., 2014; USA [30] | 3 National Institutes of Health’s Vaccine Treatment Evaluation Units | RCT, 2008–2012 | I: Women, 18–45 years of age, with no chronic conditions, a singleton, uncomplicated pregnancy with normal first- or second-trimester screening test results; E: Women who received Tdap or any tetanus-containing vaccine within the prior 2 years | Tdap (Adacel®) at 30–32 WG vs. placebo | – | 33 | 15 | vaccine-related adverse outcomes; perinatal complications; pertussis illness in infants |
Hoang et al., 2016; Vietnam [31] | Primary care | RCT, 2012–2013 | I: Women, 18–41 years of age, with low risk for complications. E: Women with any serious underlying medical condition; febrile illness within 72 h before injection, receipt of TT vaccine in the past month; receipt of Tdap in the past 10 years; receipt of a vaccine, blood product or experimental medicine 4 weeks before or after injection; previous severe reaction to any vaccine | Tdap (Adacel®) at 20–30 WG vs. TT | – | 51 | 48 | short-term vaccine-related adverse outcomes; obstetric and perinatal complications |
Halperin et al., 2018; Canada [32] | not specified, most likely outpatient hospital care | RCT, 2007–2014 | I: Healthy, pregnant women 18–45 years of age assessed at ≥30 weeks’ gestation to be at low risk for complications; E: Women with high obstetrical risk, history of significant medical disorder or physician-diagnosed pertussis or receipt of Td or Tdap in the last 5 years; sensitivity to Td or Tdap, receipt of blood products or immunoglobulin within 3 months of study entry (except rhesus Ig), or receipt of any vaccines within 2 weeks of study vaccine (except for influenza vaccine). | Tdap (Adacel®) ≥30 WG vs. TT | 273/304 (90%) | 134 | 138 | acute safety and pregnancy-related outcomes |
Berenson et al., 2016; USA [33] | University hospital | RCS, 2012–2014 | I: Singleton pregnancies delivered ≥27 WG; E: Women with < 4 clinic visits during pregnancy | Tdap (vaccine not specified) during pregnancy vs. no Tdap | – | 1109 | 650 | obstetric and perinatal complications |
DeSilva et al., 2016; USA [34] | 7 Vaccine Safety Datalink sites (Analysis of health insurance-based electronic health records) | RCS, 2007–2013 | I: Singleton live births, women continuously insured from 6 months before LMP through 6 weeks postpartum, with ≥1 outpatient visit(s) during pregnancy. I Infants: birth weight and gestational age available; enrolled in health insurance for ≥4 months in first YoL, with ≥1 outpatient visit(s); E: Infants with exposures increasing risk for structural birth defects (maternal diabetes or use of teratogenic medications, congenital infections, and chromosomal abnormalities) | Tdap (vaccine not specified) during pregnancy vs. no Tdap | 324,463 singleton live births | 41,654 | 282,809 | microcephaly and other selected major structural birth defects |
DeSilva et al., 2017; USA [35] | 7 Vaccine Safety Datalink sites (Analysis of health insurance-based electronic health records) | RCS, 2010–2013 | I: Singleton live births, women continuously insured from 6 months before LMP through 6 weeks postpartum, with ≥1 outpatient visit(s) during pregnancy. I Infants: birth weight and gestational age available; enrolled in health insurance for ≥4 months in first YoL, with ≥1 outpatient visit(s); E: Women who received live virus vaccines during pregnancy | Tdap mostly at 27–36 WG (vaccine not specified) vs. no Tdap | 197,654 /243,981 (81%) live births | 45,008 | 152,556 | obstetric and perinatal complications |
Donegan et al., 2014; UK [36] | Primary care practices, (650 primary care general practice databases, 12.5 million patients) | RCS, 2012–2013 Tdap- and 2010–2012 control group | I a.) Short-term AE risk: women ≥12 years of age who received pertussis-containing vaccination during pregnancy with ≥28 days of follow-up data after vaccination; I b.) Risk throughout pregnancy: women ≥12 years of age with a recorded pregnancy outcome and estimated gestational age with follow-up of at least 44 weeks after the date of the LMP. I Historical cohort: women ≥12 years of age with a recorded pregnancy outcome from October 2010 to September 2012 and no record of a vaccine containing pertussis during or after pregnancy | TdaP-IPV (Repevax®) during pregnancy vs. no ap-vaccine | a.): 17,560/ 20,074 (87%); b.): 6185/20,074 (31%) | 18,523 | obstetric and perinatal complications | |
Griffin et al., 2018; New Zealand [37] | Nationwide linked administrative health databases | RCS, 2013 | I: All pregnant women who reached 28–38 WG in 2013; E Women: pregnancies < 20 WG or missing maternal or gestational age; E Infants: live born babies < 28 WG or BW < 400 g | Tdap (Boostrix®) at 28–38 WG vs. no Tdap | 68,550/73,817 (93%) | 8178 | 60,372 | obstetric, perinatal and neonatal outcomes |
Kharbanda et al., 2014; USA [38] | 2 Vaccine Safety Datalink sites (Analysis of health insurance-based electronic health records) | RCS, 2010–2012 | I: Women 14–49 years of age at delivery with singleton pregnancies ending in live birth, continuously insured from 6 months before LMP through 6 weeks postpartum, ≥1 outpatient visit at an affiliated site and with birth weight and gestational age recorded; E: Women who received live virus vaccines during pregnancy or who received Tdap in the 7 days after the estimated pregnancy start date or in the 7 days before delivery; incomplete birth data | Tdap (mainly Adacel®) from 8 days after LMP to 8 days before delivery vs. no Tdap | 123,494/300,607 (41%) | 26,229 | 97,265 | obstetric and perinatal complications |
Kharbanda et al., 2016; USA [39] | Vaccine Safety Datalink sites (Analysis of health insurance-based electronic health records) | RCS, 2007–2013 | see Kharbanda, 2014 | Tdap (vaccine not specified) during pregnancy vs. no Tdap | 427,097/631,256 (68%) | 53,885 | 109,253 | acute safety endpoints in 0–42 days after vaccination |
Layton et al., 2017; USA [40] | MarketScan Commercial Claims and Encounters (Truven Health Analytics) claims databases of employer-based commercial health care insurance | RCS, 2010–2014 | I: Women with livebirth or stillbirth deliveries; only first observed pregnancy per women; E: Women who delivered at ≤26 WG; women ≤18 years in 13 states with universal childhood immunization policies | Tdap (vaccine not specified) at ≥27 WG; Tdap < 27 WG vs. no Tdap | NR | ≥27 WG: 123,780 < 27 WG: 25,037 | 871,177 | acute safety endpoints in 0–42 days after vaccination; obstetrical and perinatal complications |
Maertens et al., 2016; Belgium [15] | 5 hospitals in Antwerp, Belgium | PCS, 2012–2014 | I: Women 18–40 years of age with low risk for complications. E: Same as Hoang et al. | Tdap (Boostrix®) at 22–33 WG vs. no Tdap | NR | 57 | 42 | acute safety outcomes obstetric and perinatal complications |
Morgan et al., 2015; USA [41] | Parkland clinic-based pre-natal and obstetrical care centers in Dallas County with centralized electronic medical charting system | RCS, 2013–2014 | I: All women who delivered at Parkland | Tdap (vaccine not specified) at ≥32 WG vs. no Tdap | NR | 7152 | 226 | obstetric and neonatal outcomes |
Shakib et al., 2013; USA [42] | Intermountain Healthcare database, Utah | RCS, 2005–2009 | I: Pregnant women 12–45 years of age and their babies; E: Women whose pregnancy start date could not be determined; women who had documentation of Tdap vaccine within 3 days prior to delivery | Tdap (vaccine not specified) at any time during pregnancy vs. no Tdap | 162,448 | 138 | 552 | obstetric and perinatal complications; congenital anomalies, complex chronic conditions in 1st YoL |
b.) Studies addressing effectiveness outcomes | ||||||||
Authors/country | Setting/data source | study design/period | Participants (Inclusion (I) and exclusion (E) criteria) | Intervention/comparator | N | Pertussis cases | control group | outcomes |
Amirthalingam et al., 2014, UK [43] | notification data from enhanced surveillance for pertussis cases; and sentinel primary care data (Clinical Practice Research Datalink) for vaccination coverage calculations | RCS; screening method, 2008–2013 | I: infants < 3 months of age; E: unknown maternal vaccination status, vaccination given within 7 days of birth; first primary infant vaccination before 7 days of disease onset | maternal Tdap-IPV (Repevax®) at 28–38 WG vs. no Tdap | NR | 71 | 26,684 | laboratory confirmed pertussis at < 2 and < 3 months of age |
Amirthalingam et al., 2016, UK [16] | see Amirthalingam et al., 2014, UK [43] | RCS screening method, 2012–2015 | see Amirthalingam et al., 2014, UK [43] | maternal Tdap-IPV (Repevax®, Boostrix-Polio®) at 28–38 WG vs. no Tdap | NR | 192 | 72,781 | laboratory confirmed pertussis at < 2 and < 3 months of age; pertussis related deaths |
Baxter et al., 2017, USA [44] | Kaiser Permanente Northern California (KPNC) medical care data | RCS, 2010–2015 | I: infants born in KPNC hospitals 2010–2015; full term (> = 37 WG); enrolled in Kaiser health plan by age 4 months; mother continuously enrolled in KPNC health plan; mother born before 1996 | maternal Tdap vaccination (Boostrix®, Covaxis®) at least 8 days before birth vs. no Tdap | 148,981 | 17 | 148,964 | laboratory confirmed pertussis at < 2 months of age |
Becker-Dreps et al., 2018, USA [45] | commercial insurance claims data | RCS, 2010–2014 | I: infants </= 18 months of age, delivered between June 2010 and Dec. 2014; First delivery per women; singleton deliveries occurring > 26 WG; E: non-continuous insurance enrolment from pregnancy onset until 7 days post-delivery | maternal Tdap vaccination (vaccine not specified) vs. no Tdap | 632,825 | 112 | 632,713 | laboratory confirmed pertussis at < 2 months of age; pertussis-related hospitalization |
Bellido-Blasco et al., 2017, Spain [46] | community-based data; cases were identified via computerized mandatory notification system | CCS, 2015–2016 | I: cases: unvaccinated infants < 3 months old, with confirmed pertussis; controls: three paired controls by age (difference less than 15 days) per case; two controls: same paediatrician/family doctor as case; third control: same maternity clinic as case; controls: unvaccinated | maternal Tdap vaccination (vaccine not specified) vs. no Tdap | 88 | 22 | 66 | laboratory confirmed pertussis at < 3 months of age |
Dabrera et al., 2015, England and Wales [47] | community-based data; cases were identified via notification system; controls were 2 infants born consecutively after pertussis case from the same practice | CCS, 2012–2013 | E infants: aged ≥8 weeks, unknown vaccination status of mother; E controls: known clinical or microbiological diagnosis of pertussis | maternal Tdap-IPV (Repevax®) at any time in pregnancy vs. no Tdap | 113 | 58 | 55 | laboratory confirmed pertussis at <2 months ofage |
Saul et al., 2017, Australia [48] | cases were identified via notification system; controls: infant born +/−3 days as case in the maternity clinic of the local health district in which the case was notified | CCS, 2015–2016 | E controls: cough illness within two weeks of the onset of the illness in the matched case | maternal Tdap at ≤2 weeks before birth with a 3-component acellular pertussis vaccine vs. no Tdap | 96 | 48 | 48 | laboratory confirmed pertussis at < 3 months of age; pertussis-related hospitalization |
Skoff et al., 2017, USA [49] | cases were identified via surveillance in 6 Emerging Infection Program Network sites; controls were hospital-matched | CCS, 2011–2014 | I: infants ≥2 days old, residing in the catchment area on their cough onset date, were born in a hospital in their state of residence, were delivered at ≥37 WG, were not adopted or in foster care, and did not live in a residential care facility. E controls: pertussis diagnosis prior to the cough onset date of the corresponding case infant | any pertussis-containing vaccine at any time in pregnancy vs. no Tdap | 6252 | 240 | 535 | laboratory confirmed pertussis at <2 months of age; pertussis-related hospitalization |
Vaccine safety
Evidence base and risk of bias
Study | Outcome definition | Design | Intervention/comparison group | WG at vaccination: mean (range) | Tdap-vaccinated group | Control group | Unadjusted estimate (95%CI) | Adjusted estimate (95% CI) | ||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
N | ncases | % | N | ncases | % | |||||||
Fever | ||||||||||||
Hoang et al., 2016 [31] | Self-reported fever without time limit | RCT | Tdap/TT | 25.8 (18–36) | 52 | 1 | 1.9 | 48 | 0 | 0.0 | NR | NR |
Munoz, 2014 [30] | Oral temperature of ≥38° Celsius during 7 days after Tdap vaccination | RCT | Tdap/placebo | 30–32 | 33 | 1 | 3.0 | 15 | 0 | 0.0 | NR | NR |
Maertens et al., 2016 [15] | Fever | PCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 1 | 1.8 | 42 | 0 | 0.0 | NR | NR |
Kharbanda et al., 2016 [39] | Medically attended fever during 3 days after Tdap vaccination | RCS | Tdap/no Tdap | 81.8% ≥20 | 53,885 | 15 | 0.03 | 109,253 | 6 | 0.006 | 2.16 (1.65–2.83)a | NR |
Stillbirth | ||||||||||||
Hoang et al., 2016 [31] | Stillbirth | RCT | Tdap/TT | 25.8 (18–36) | 52 | 0 | 0.0 | 51 | 1 | 2.0 | NR | NR |
Berenson et al., 2016 [33] | Stillbirth | RCS | Tdap/no Tdap | 30.3 (1–40) | 650 | 0 | 0.0 | 1109 | 1 | 0.1 | NR | NR |
Donegan et al., 2014 [36] | Intrauterine death after 24 WG within 14 days of vaccination | RCS | Tdap-IPV/no Tdap | 31 (29–35) | 13,371 | 5 | 0.0 | 13,371 | 7.2 (expected) | 0.1 | 0.69 (0.23–1.62) | NR |
Intrauterine death after 24 WG from vaccination to delivery | 33 (30–36) | 6185 | 12 | 0.2 | 18,523 | 42 | 0.3 | 0.85 (0.44–1.61) | NR | |||
Morgan et al., 2015 [41] | Stillbirth | RCS | Tdap ≥32 WG/no Tdap | ≥32 | 7152 | 25 | 0.3 | 226 | 1 | 0.4 | 0.79 (0.11–5.85)b | NR |
Shakib et al., 2013 [42] | Stillbirth | RCC | Tdap 3–280 days prepartal/no Tdap | 87 (63%) 1st, 24 (17%) 2nd, 27 (20%) 3rd trimester | 138 | 0 | 0.0 | 552 | 5 | 0.9% | 0.36 (0.02–6.54)b | NR |
Neonatal death | ||||||||||||
Morgan et al., 2015 [41] | Not defined | RCS | Tdap ≥32 WG/no Tdap | ≥32 WG | 7152 | 2 | 0.028 | 226 | 0 | 0 | 0.16 (0.01–3.31)b | NR |
Donegan et al., 2014 [36] | Neonatal death within 7 days of delivery | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 2 | 0.032 | 18,523 | 6 | 0.032 | 1.00 (0.20–4.95) | NR |
Preterm birth | ||||||||||||
Berenson et al., 2016 [33] | < 37 WG | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 58 | 5.2 | 650 | 59 | 9.1 | 0.77 (0.64–0.93)a | 0.68 (0.45–1.03) |
Kharbanda et al., 2014 [38] | < 37 WG | RCS | Tdap in any WG/no Tdap | 2.014 (7.7%) 1st, 10.936 (41.7%) 2nd, 13.280 (50.6%) 3rd trimester | 26,229 | 1.527 | 6.3 | 97,265 | 7544 | 7.8 | 1.01 (0.95–1.06) | 1.03 (0.97–1.09) |
Tdap 27–36 WG/no Tdap | 11,351 | 602 | 5.3 | 97,265 | 7544 | 7.8 | 0.88 (0.81–0.96) | 0.88 (0.80–0.95) | ||||
Layton et al., 2017 [40] | Not defined; presumably < 37 WG | RCS | Tdap/no Tdap | < 27 | 25,037 | 2.593 | 10.4 | 871,177 | 66,968 | 7.7 | 1.37 (1.32–1.43)a | NR |
≥27 | 123,780 | 6.154 | 5.0 | 871,177 | 66,968 | 7.7 | 0.66 (0.64–0.68)a | NR | ||||
Shakib et al., 2013 [42] | < 37 WG | RCC | Tdap 3–280 days antepartum/no Tdap | 87 (63%) 1st, 24 (17%) 2nd, 27 (20%) 3rd trimester | 134 | 8 | 6.0 | 505 | 38 | 7.5 | 0.78 (0.36–1.71)b | NR |
Munoz et al., 2014 [30] | < 37 WG | RCT | Tdap/placebo | 30–32 | 33 | 3 | 9.1 | 15 | 1 | 6.7 | 1.50 (0.14–15.67)b | NR |
Griffin et al., 2018 [37] | Premature birth ICD-10-AM O60.1.3; birth < 37 WG | RCS | Tdap 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 297 | 3.6 | 60,372 | 2829 | 4.7 | 0.74 (0.66–0.84) | 0.72 (0.63–0.83) |
Morgan et al., 2015 [41] | < 37 WG | RCS | Tdap at ≥32 WG/no Tdap | ≥32 | 7152 | 427 | 5.9 | 226 | 27 | 11.9 | 0.47 (0.31–0.71)b | NR |
Hoang et al., 2016 [31] | Not defined | RCT | Tdap/ TT | 25.8 (18–36) | 52 | 0 | 0.0 | 51 | 1 | 2.0 | NR | NR |
DeSilva et al., 2017 [35] | < 34 WG | RCS | Tdap in any WG/no Tdap | 51% 27–36 | 45,008 | 426 | 0.9 | 152,556 | 2711 | 1.8 | 0.59 (0.54–0.65)a | NR |
Halperin et al., 2018 [32] | MedDRA version 19.0 - definition | RCT | Tdap/Td | 34.5 (32.6–35.6) | 134 | 2 | 1.5 | 138 | 1 | 0.7 | 2.06 (0.19–22.45) | NR |
Low birth weight | ||||||||||||
Berenson et al., 2016 [33] | LBW: < 2500 g | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 61 | 5.5 | 650 | 59 | 9.1 | NR | 0.76 (0.51–1.14) |
VLBW: < 1500 g | 1109 | 2 | 1.1 | 650 | 12 | 0.3 | NR | 0.24 (0.05–1.20) | ||||
Griffin et al., 2018 [37] | Intrauterine growths retardation (ICD10-AM O36.5) | RCS | Tdap 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 401 | 4.9 | 60,372 | 2916 | 4.8 | 0.94 (0.84–1.04) | 0.92 (0.82–1.04) |
Donegan et al., 2014 [36] | Intrauterine growths retardation/LBW < 2500 g | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 126 | 2.0 | 18,523 | 311 | 1.7 | 1.20 (0.98–1.48) | NR |
Neonatal sepsis | ||||||||||||
Layton et al., 2017 [40] | Sepsis in the newborn during 30 days after birth | RCS | Tdap/no Tdap | < 27 WG | 16,322 | 394 | 2.41 | 543,906 | 13,187 | 2.27 | 1.07 (0.97–1.18) | 0.89 (0.81–0.99)c 0.91 (0.81–1.02)d |
≥27 WG | 80,217 | 1.774 | 1.84 | 543,906 | 13,187 | 2.27 | 0.81 (0.77–0.85) | 0.83 (0.79–0.88)c 0.89 (0.84–0.94)d | ||||
Admission to newborn intensive care unit | ||||||||||||
Layton et al., 2017 [40] | Admission to newborn intensive care unit during 30 days after birth | RCS | Tdap/no Tdap | < 27 WG | 16,322 | 1.458 | 8.93 | 543,906 | 42,904 | 7.39 | 1.22 (1.16. 1.29) | 0.93 (0.88–0.98)c 0.95 (0.89–.01)d |
≥27 WG | 80,217 | 6996 | 7.25 | 543,906 | 42,904 | 7.39 | 0.98 (0.96–1.01) | 0.97 (0.95–1.00)c 1.00 (0.97–1.03)d | ||||
Berenson et al., 2016 [33] | Not defined | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 103 | 9.3 | 650 | 86 | 13.2 | NR | 0.78 (0.56–1.08) |
Preeclampsia and eclampsia | ||||||||||||
Griffin et al., 2018 [37] | Hypertension (ICD10-AM O13-O16) | RCS | Tdap in 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 262 | 3.2 | 60.372 | 1484 | 2.5 | 1.20 (1.05–1.37) | 1.02 (0.88–1.19) |
Preeclampsia (ICD10-AM O14.09) | 133 | 1.6 | 1007 | 2.5 | 0.91 (0.75–1.09) | 0.85 (0.69–1.04) | ||||||
Severe preeclampsia (ICD10-AM O14.1) | 26 | 0.3 | 271 | 0.4 | 0.67 (0.45–1.00) | 0.61 (0.39–0.94) | ||||||
Layton et al., 2017 [40] | Preeclampsia/eclampsia (642.4x-642.8x)ICD-9 codes 624.xx during 7 days pre- and up to 30 days postpartum | RCS | Tdap/no Tdap | < 27 | 25,037 | 1.096 | 4.38 | 871,177 | 40,930 | 4.4 | 1.00 (0.94–1.06) | 0.99 (0.93–1.05)c 1.05 (0.99–1.12)d |
≥27 | 123,780 | 5.248 | 4.24 | 871,177 | 40,930 | 4.4 | 0.96 (0.94–0.99) | 0.90 (0.87–0.93)c 0.96 (0.94–0.99)d | ||||
Kharbanda et al., 2014 [38] | Gestational hypertension (ICD642.3x). Hypertension in pregnancy (ICD642.9) Preeclampsia or eclampsia (ICD642.4x-642.8x); onset ≥20 WG | RCS | Tdap< 20 WG/no Tdap | 2.014 (7.7%) 1st, 10.936 (41.7%) 2nd, 13.280 (50.6%) 3rd trimester | 6083 | 497 | 8.2 | 97,265 | 7736 | 8.0 | 1.03 (0.94–1.12) | 1.09 (0.99–1.20) |
Donegan et al., 2014 [36] | Not defined; clinical diagnoses during pregnancy from primary care general practice databases | RCS | Tdap-IPV/no Tdap | 33 (30–36) | 6185 | 22 | 0.4 | 18,523 | 54 | 0.3 | 1.22 (0.74–2.01) | NR |
Halperin et al., 2018 [32] | Preeclampsia (MedDRA version 19.0- definition) | RCT | Tdap/Td | 34.5 (32.6–35.6) | 134 | 1 | 0.7 | 138 | 2 | 1.4 | 0.51 (0.05–5.61) | NR |
Maertens et al., 2016 [15] | Preeclampsia | PCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 4 | 7.0 | 41 | 1 | 2.4 | 1.40 (0.88–2.25)a | NR |
Hypertension | 57 | 2 | 3.5 | 41 | 1 | 2.4 | 1.15 (0.51–2.61)a | NR | ||||
Preeclampsia or hypertension | 57 | 6 | 10.5 | 41 | 2 | 4.9 | 1.32 (0.85–2.05)a | NR | ||||
Malformations | ||||||||||||
Hoang et al., 2016 [31] | Not defined. Not reported in results section | RCT | Tdap/TT | 25.8 (18–36) | 52 | 0 | 0.0 | 48 | 0 | 0.0 | NR | NR |
Munoz et al., 2014 [30] | Not defined | RCT | Tdap/placebo | 30–32 | 33 | 1 | 3.0 | 15 | 2 | 13.3 | 0.2 (0.02–2.44)b | NR |
Berenson et al., 2016 [33] | Ten most commonly encountered birth defects reported by the Centers for Disease Control and Prevention | RCS | Tdap/no Tdap | 30.3 (1–40) | 1109 | 18 | 1.6 | 650 | 15 | 2.3 | NR | 0.80 (0.38–1.67) |
DeSilva et al., 2016 [34] | Diagnostic codes for any structural birth defect, diagnosed during first YOL | RCS | Tdap/no Tdap | any WG | 41,654 | 2816 | 6.8 | 282,809 | 17,422 | 6.2 | 1.09 (1.05–1.14) | 0.98 (0.94–1.03) |
27–36 (50%) | 20,568 | 1435 | 7.0 | 120,097 | 8367 | 7.0 | 1.00 (0.95–1.06) | 1.02 (0.96–1.08) | ||||
Diagnostic codes for selected major structural birth defects: such as spina bifida (741.0x and 741.9x); encephalocele, etc., diagnosed during first YOL | any WG | 41,654 | 717 | 1.7 | 282,809 | 4521 | 1.6 | 1.08 (1.00–1.17) | 1.06 (0.98–1.16) | |||
27–36 (50%) | 20,568 | 356 | 1.7 | 120,097 | 1920 | 1.60 | 1.08 (0.97–1.21) | 1.09 (0.97–1.23) | ||||
Diagnostic codes for microcephaly, diagnosed during first YOL | any WG | 41,654 | 38 | 0.09 | 282,809 | 348 | 0.12 | 0.74 (0.53–1.04) | 0.86 (0.60–1.24) | |||
27–36 WG (50%) | 20,568 | 21 | 0.10 | 120,097 | 146 | 0.12 | 0.84 (0.53–1.33) | 1.01 (0.63–1.61) | ||||
Maertens et al., 2016 [15] | Not defined | RCS | Tdap/no Tdap | 28.6 (22–33) | 57 | 0 | 0.0 | 42 | 0 | NR | NR | |
Morgan et al., 2015 [41] | Major malformations | RCS | Tdap ≥32 WG/no Tdap | ≥32 WG | 7152 | 84 | 1.2 | 226 | 3 | 1.3 | 0.88 (0.28–2.82)b | NR |
Chorioamnionitis | ||||||||||||
Berenson et al., 2016 [33] | Physician’s diagnosis in medical file AND fever ≥38 °C AND ≥1 of the following symptoms: uterine tenderness, malodorous vaginal discharge or maternal leucocytosis | RCS | Tdap in any WG/no Tdap | 30.3 (1–40) | 1.109 | 39 | 3.5 | 650 | 14 | 2.2 | NR | 1.53 (0.80–2.90) |
Kharbanda et al., 2014 [38] | ICD-9 code 658.41 as diagnosis during stay in birth clinic | RCS | Tdap in any WG/no Tdap | 2014 (7.7%) 1st, 10,936 (41.7%) 2nd 13,280 (50.6%) 3rd trimester | 26,229 | 1596 | 6.1 | 97,265 | 5329 | 5.5 | 1.11 (1.05–1.17) | 1.19 (1.13–1.26) |
Tdap during 27–36 WG/no Tdap | 11,351 | 637 | 5.6 | 97,265 | 5329 | 5.5 | 1.02 (0.95–1.11) | 1.11 (1.03–1.21) | ||||
Layton et al., 2017 [40] | ICD-9762.7. 658.4. 658.4x coded for mother or newborn during stay in birth clinic | RCS | Tdap/no Tdap | < 27 | 25,037 | 984 | 3.93 | 871,177 | 25,149 | 2.7 | 1.45 (1.37–1.55) | 1.23 (1.16–1.31)c 1.19 (1.11–1.28)d |
≥27 | 123,780 | 4529 | 3.66 | 871,177 | 25,149 | 2.7 | 1.35 (1.31–1.40) | 1.14 (1.10–1.18)c 1.11 (1.07–1.15)d | ||||
DeSilva et al., 2017 [35] | ICD-9 code 658.41 from maternal medical file during stay in birth clinic | RCS | Tdap at any WG/no Tdap | 51% 27–36 | 45,008 | 2.883 | 6.4 | 152,556 | 7970 | 5.2 | NR | 1.23 (1.17–1.28) |
Tdap during 27–36 WG/no Tdap | 22,772 | 1430 | 6.3 | 133,882 | 7109 | 5.3 | NR | 1.20 (1.14–1.28) | ||||
Griffin et al., 2018 [37] | ICD-10-AM O41.1 | RCS | Tdap during 28–38 WG/no Tdap | 33. IQR: 30–35 | 8178 | 26 | 0.3 | 60,372 | 198 | 0.3 | 0.89 (0.59–1.34) | 1.10 (0.70–1.75) |
Morgan et al., 2015 [41] | Not defined. Extracted from data base with information on pregnancy, birth and newborn | RCS | Tdap ≥32 WG/no Tdap | ≥32 | 7152 | 421 | 5.9 | 226 | 9 | 4.0 | 1.51 (0.77–2.96)b | NR |
Fever
Stillbirth
Neonatal deaths
Preterm birth
Low birth weight
Congenital malformations
Neonatal septicaemia
Admission to NICU
Pre-eclampsia and eclampsia
Chorioamnionitis
Vaccine effectiveness
Evidence base and risk of bias
Pertussis in infants 0–3 months of age
Study | Design | Intervention/ control | Study population | Pertussis cases | Non-cases /controls | unadjusted effect estimate (95%CI) | adjusted effect estimate (95%CI) | ||||
---|---|---|---|---|---|---|---|---|---|---|---|
N | Cases with vaccinated mothers | N | Non-cases with vaccinated mothers | ||||||||
n | % | n | % | ||||||||
Prevention of laboratory confirmed pertussis in infants aged 0–2 months | |||||||||||
Amirthalingam et al., 2014 [43] | CS, screening method | dTaP-IPV/no vaccination | 26,684 | 71 | 11 | 14 | 61 | VE = 90% (82–95) | NR | ||
Amirthalingam et al., 2016 [16] | CS, screening method | dTaP-IPV/no vaccination | 72,781 | 192 | 31 | 16 | 64 | VE = 90% (86–93) | NR | ||
Baxter et al., 2017 [44] | CS | Tdap/no vaccination | 148,981 | 17 | 1 | 6 | 148,964 | 68,167 | 46 | IRR = 0.08 (0.00–0.43); VE = 87% | 91% (20–99) |
Dabrera et al., 2015 [47] | CCS | dTaP-IPV/no vaccination | 113 | 58 | 10 | 17 | 55 | 39 | 71 | OR: 0.09 (0.03–0.23) VE = 91% (77–97) | 93% (81–97) |
Skoff et al., 2017 [49] | CCS | Tdap/no vaccination | 775 | 240 | 17 | 7 | 535 | 90 | 17 | VE = 62% | 78% (48–90) |
Becker-Dreps et al., 2018 [45] | CS | Tdap/no vaccination | 632,825 | 112 | 7 | 0.01 | 632,713 | 90,438 | 0.02 | HR: 0.33 (0.12–0.90); VE: 67% | HR: 0.54 (0.19–1.59); VE: 46% |
Prevention of laboratory confirmed pertussis in infants aged 0–3 months | |||||||||||
Amirthalingam et al., 2014 [43] | CS, screening method | dTaP-IPV/no vaccination | 26,684 | 82 | 12 | 15 | 62 | VE = 91% (84–95) | NR | ||
Amirthalingam et al., 2016 [16] | CS, screening method | dTaP-IPV/no vaccination | 72,781 | 243 | 35 | 14 | 65 | VE = 91% (88–94) | NR | ||
Bellido-Blasco et al., 2017 [46] | CCS | Tdap/no vaccination | 88 | 22 | 5 | 23 | 66 | 41 | 62 | OR: 0.08 (0.017–0.371) | 91% (57–98) |
Saul et al., 2017 [48] | CCS | Tdap/no vaccination | 96 | 48 | 19 | 40 | 48 | 33 | 69 | OR: 0.36 = VE: 64% | 69% (13–89) |
Prevention of hospitalization due to laboratory confirmed pertussis in infants aged 0–2 and 0–3 months, respectively (percentage of lab-confirmed cases unclear in the study by Becker-Dreps et al.) | |||||||||||
Saul et al., 2017 [48] | CCS (age ≤ 3 months) | Tdap/no vaccination | 74 | 37 | 37 | OR: 0.16 (0.05–0.53) | OR: 0.06 (0.01–0.41); VE: 94% (59–99) | ||||
Skoff et al., 2017 [49] | CCS (age ≤ 2 months) | Tdap/no vaccination | 6252 | 157 | 535 | NR | 2nd trimester: 91% (25–99) 3rd trimester: 91% (65–97) | ||||
Becker-Dreps et al., 2018 [45] | CS (age ≤ 2 months) | Tdap/no vaccination | 632,825 | 80 | 4 | 0.00 | 632,745 | 90,441 | 0.01 | HR = 0.23 (0.06–0.96) VE: 77% | HR = 0.34 (0.08–1.50) VE: 66% |
Prevention of death due to laboratory confirmed pertussis in infants aged 0–3 months | |||||||||||
Amirthalingam et al., 2016 [16] | CS, screening method | dTaP-IPV/ No vaccination | 243 | 11 | 1 | 9 | 232 | 158 | 68 | VE = 95% (79–100) | NR |