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Table 1 Characteristics of included studies

From: Efficacy and safety of pertussis vaccination for pregnant women – a systematic review of randomised controlled trials and observational studies

Authors Country Setting Study design Dates of recruitment Participants Inclusion (I)/Exclusion (E) Intervention Exposure Comparisons N Outcomes
Abu Raya [26] Israel Hospital In−/outpatients not specified PCS 2013–2014 I: pregnant women with singleton births at gestational age ≥ 36 weeks E: pregnant women with a newborn <2000 g; immunologic disorder; immunoglobulins in the previous year; immunosuppressive drugs in the current pregnancy; pertussis infection or pertussis-containing vaccine within 5 years or any vaccine besides Tdap within 2 weeks of delivery. Tdap ≥20 weeks’ gestation No Tdap during pregnancy 81 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA
Abu Raya [27] Israel Same as above PCS 2013–2014 I: pregnant women with singleton births; gestational age ≥ 36 weeks; intending to breast feedE: same as Abu Raya et al. [26] Tdap ≥20 weeks’ gestation No Tdap during pregnancy 37 Anti-pertussis antibodies in breast milk measured by ELISA
Dabrera [37] UK Community- based data CCS 2012–2013 E: any potentially confounding protective effect from active immunisation. Any pertussis-containing vaccine at any time in pregnancy No pertussis-containing vaccine during pregnancy 113 Pertussis infection in infants; pertussis related complications as measured by the length of hospital stay in infants
De Schutter [28] Belgium Hospitals In−/outpatients not specified PCS 2013–2014 E: Women who delivered prematurely, who had received another vaccine or any blood product in the previous month. Tdap during the 2nd or 3rd trimester No Tdap during pregnancya 28a Anti-pertussis antibodies in breast milk measured by ELISA
Donegan [32] UK Community- based data RCS 2012–2013 for vaccine group/ 2010–2012 for control group I: women aged ≥12 who had a pertussis-containing vaccination during pregnancy and at least 28 days of follow-up data after vaccination Any pertussis vaccine at any time during pregnancy No pertussis-containing vaccine during pregnancy 38,900 Obstetric and perinatal complications
Gall [5] US Hospital In−/outpatients not specified RCS 2008–2009 I: pregnant women who had been admitted to the hospital at the study site and their babies Tdap at any time during pregnancyb No Tdap during pregnancy 104 Anti-pertussis antibodies in infants’ sera measured by ELISA
Hardy-Fairbanks [33] Not specifiedc Not specifiedb PCS 2006 for vaccine group/ 2008–2009 for control group E: Women with multiple gestations; serious underlying health issues in either the mother or infant, preterm infants, or infants who needed transfusions or who had been advised not to have blood drawn for health reasons Tdap at any time during pregnancy No Tdap during pregnancy 70 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA
Healy [34] US Hospital In−/outpatients not specified RCS 2009–2011 I: Women who delivered at ≥37 weeks’ gestation; received Tdap within 2 years; and had plasma–serum pairs available Tdap at any time during pregnancy Tdap before pregnancy 105 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA
Hoang [30] Vietnam Community RCT 2012–2013 I: Women aged 18–41 with low risk for complications.E: Women with: any serious underlying medical condition; febrile illness in the 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 in the 4 weeks before or after injection; previous severe reaction to any vaccine Tdap, 20–30 weeks’ gestation TT during pregnancy 103 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; vaccine-related adverse outcomes; obstetric and perinatal complications.
Kharbanda [24] US Community- based data RCS 2010–2012 I: Women with singleton pregnancies with a live birth E: women with live virus vaccines during pregnancy; Tdap in the 7 days after the estimated pregnancy start date or in the 7 days before delivery; incomplete birth data Tdap at any time during pregnancyd No Tdap during pregnancy 123,494 Obstetric and perinatal complications
Kharbanda [25] US Community- based data RCS 2007–2013 Same as Kharbanda et al. [24] Tdap at any time during pregnancyd No Tdap during pregnancy 163,138 Obstetric complications occurring within 42 days of vaccination.
Ladhani [35] UK Community- based data RCS 2012–2014 for vaccine group/ 2011–2012 for control group I: Any infant eligible for the national immunisation program Tdap-IPV No pertussis -containing vaccine during pregnancy 387 Antibody responses after primary immunisation in infants’ sera measured by ELISA.
Maertens [29] Belgium Hospitals In−/outpatients not specified PCS 2012–2014 I: Women aged 18–40 with low risk for complications. E: same as Hoang et al. [30] Tdap at 22–33 weeks’ gestation No pertussis-containing vaccine during pregnancy 99 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; obstetric complications
Munoz [31] US NIH Vaccine Treatment Evaluation Unit RCT 2008–2012 I: Women aged 18–45 with no underlying chronic medical 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 at 30–32 weeks’ gestation Placebo 45 Anti-pertussis antibodies in mothers’ and infants’ sera measured by ELISA; vaccine-related adverse outcomes; perinatal complications; pertussis infection in infants
Shakib [36] US Healthcare database RCS 2005–2009 I: Pregnant women 12–45 years of age and their babies E: Women who had documentation of Tdap vaccine within 3 days prior to the delivery outcome Tdap at any time during pregnancy No Tdap during pregnancy 690 Pertussis infection in infants; perinatal complications
  1. RCT randomised control trial, PCS prospective cohort study, RCS retrospective cohort study, CCS case-control study, Tdap a combined tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine, TdaP/IPV a combined tetanus, low-dose diphtheria, five-component acellular pertussis, inactivated polio vaccine, TT tetanus toxoid vaccine, ELISA Enzyme-linked immunosorbent assays
  2. aDe Schutter et al. compared different maternal pertussis vaccination strategies. This review only included women with Tdap during pregnancy (n = 19) and women with no pertussis vaccination for at least for 5 years before delivery (n = 9)
  3. bWomen in the study were encouraged to receive Tdap during the second trimester of pregnancy, but the exact timing of its administration could not be determined
  4. cHardy-Fairbanks et al. did not mention the study setting. The study appears, however, to have been conducted in the United States, according to the available information (the authors’ institutional affiliations and the acknowledgements section). The authors also described cases of pertussis that had been reported in New Hampshire during the period when the study participants were recruited
  5. dTdap vaccine received from 8 days after the last menstrual period to seven to 8 days before delivery