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Table 4 Safety of maternal antenatal pertussis vaccine

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

  Study design Intervention/exposure type, mean gestational week at vaccination (range) Compara-tor Vaccine group Control group Crude RR (95% CI) Adjusted RR (95% CI)
Event n. (%) N Event n. (%) N
ADVERSE EVENTS (AE)
Any solicited adverse events
 Hoang [30]a RCT Tdap 26 (19–35) TT 23 (44.2) 52 22 (43.1) 51 1.0 (0.7–1.6)  
 Munoz [31]b RCT Tdap -- (30–32) placebo 26 (78.8) 33 5 (33.3) 15 2.4 (1.1–4.9)  
 Any injection site reactions     26 (78.8) 33 3 (20.0) 15 3.9 (1.4–11.0)  
  (pain)     25 (75.8) 33 2 (13.3) 15 5.7 (1.5–20.9)  
  (erythema/redness)     3 (9.1) 33 1 (6.7) 15 1.4 (0.2–12.1)  
  (induration/swelling)     3 (9.1) 33 0 (0) 15 NAc  
 Any systemic symptoms     12 (36.4) 33 3 (20.0) 15 1.8 (0.6–5.5)  
  (fever)     1 (3.0) 33 0 (0) 15 NAc  
  (headache)     11 (33.3) 33 3 (20.0) 15 1.7 (0.5–5.1)  
  (malaise)     4 (12.1) 33 2 (13.3) 15 0.9 (0.2–4.4)  
  (myalgia)     5 (15.2) 33 0 (0) 15 NAc  
OBSTETRIC COMPLICATIONS
Hypertensive disorders
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 22 (0.4) 6185 54 (0.3) 18,523 1.2 (0.7–2.0)  
 Kharbanda [24] RCS Tdap, before 20 no vaccine 497 (8.2) 6083 7736 (8.0) 97,265 1.0 (0.9–1.1) 1.1 (1.0–1.2)e
 Maertens [29]d PCS Tdap 29 (22–33) no vaccine 6 (10.5) 57 2 (4.9) 41 2.2 (0.5–10.2)  
Premature contraction
 Hoang [30] RCT Tdap 26 (19–35) TT 2 (3.8) 52 1 (2.0) 51 2.0 (0.2–21.0)  
 Maertens [29] PCS Tdap 29 (22–33) no vaccine 4 (7.0) 57 0 (0) 41 NAc  
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 5 (0.1) 6185 21 (0.1) 18,523 0.7 (0.3–1.9)  
 Chorioamnionitis
 Kharbanda [24] RCS Tdap -- (anytime) no vaccine 1596 (6.1) 26,229 5329 (5.5) 97,265 1.11 (1.05–1.17) 1.2 (1.13–1.3)e
  (subset)   Tdap, 2736   637 (0.1) 11,351 5329 (0.1) 97,265 1.02 (0.95–1.11) 1.1 (1.0–1.2) e
Proteinuria
 Kharbanda [25]f RCS Tdap -- (anytime) no vaccine 84 (0.2) 53,885 207 (0.2) 109,253 0.8 (0.6–1.1) 0.8 (0.6–1.1)g
 Caesarean section
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 1238 (20.0) 6185 3748 (20.2) 18,523 1.0 (0.9–1.0)  
Postpartum haemorrhage
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 59 (1.0) 6185 181 (1.0) 18,523 1.0 (0.7–1.3)  
Venous thromboembolism
 Kharbanda [25]f RCS Tdap -- (anytime) no vaccine 22 (0.04) 53,885 69 (0.1) 109,253 0.6 (0.4–1.0) 0.7 (0.4–1.1)g
Thrombocytopenia
 Kharbanda [25]f RCS Tdap, ≥ 20 no vaccine 249 (0.1) 44,063 579 (0.1) 86,057 0.8 (0.7–1.0) 0.9 (0.7–1.0)g
Gestational diabetes
 Kharbanda [25]f RCS Tdap, ≥ 20 no vaccine 1101 (2.5) 44,063 2263 (2.6) 86,057 1.0 (0.9–1.0) 1.0 (0.9–1.0)g
Cardiac events
 Kharbanda [25]f RCS Tdap, ≥ 20 no vaccine 90 (0.2) 44,063 198 (0.2) 86,057 0.9 (0.7–1.1) 0.9 (0.7–1.2)g
Oligohydramnios
 Maertens [29] PCS Tdap 29 (22–33) no Tdap 1 (1.8) 57 0 (0) 41 NAc  
Placenta praevia
 Maertens [29] PCS Tdap 29 wks (22–33) no vaccine 0 (0) 57 1 (2.44) 41 0 (NA)c  
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 2 (< 0.1) 6185 15 (0.1) 18,523 0.4 (0.1–1.7)  
PERINATAL COMPLICATIONS
Stillbirth
 Hoang [30] RCT Tdap 26 (19–35) TT 0 (0) 52 1 (2.0) 51 0 (NA)c  
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 12 (0.2) 6185 42 (0.2) 18,523 0.9 (0.5–1.6)  
 Shakib [36] RCS Tdap -- (anytime) no vaccine 0 (0) 138 5 (0.9) 552 0 (NA)c  
Neonatal death
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 2 (<0.1) 6185 6 (<0.1) 18,523 1.0 (0.2–4.9)  
Preterm births
 Munoz [31] RCT Tdap -- (30–32) no vaccine 3 (9.1) 33 1 (6.7) 15 1.4 (0.2–12.1)  
 Hoang [30] RCT Tdap 26 (19–35) TT 0 (0) 52 1 (2.0) 51 0 (NA)c  
 Kharbanda [24] RCS Tdap -- (anytime) no vaccine 1527 (5.8) 26,229 7544 (7.8) 97,265 0.8 (0.7–0.8)h 1.0 (1.0–1.1)e
 Shakib [36] RCS Tdap -- (anytime) no vaccine 8 (6.0) 134 38 (7.5) 505 0.8 (0.4–1.7)  
SGA (<10th percentile)
 Kharbanda [24] RCS Tdap -- (anytime) no vaccine 2214 (8.4) 26,229 8086 (8.3) 97,265 1.0 (1.0–1.0) 1.0 (1.0–1.1)e
Low birth weight (< 2500 g)
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine 126 (2.0) 6185 311 (1.7) 18,523 1.2 (1.0–1.5)  
 Birth weight (kg)
 Munoz [29] RCT Tdap -- (30–32) placebo Mean 3.2 (SD 0.5) 33 Mean 3.5 (SD 0.7) 15 MD −0.3 (−0.7–0.1)  
 Donegan [32] RCS Any pertussis vaccine--(anytime) no vaccine Median 3.5 6185 Median 3.5 18,523 Median difference 0  
Apgar scores 1 min
 Munoz [31] RCT Tdap -- (30–32) no vaccine Mean 8.0 (SD 1.4) 33 Mean 7.9 (SD 1.1) 15 MD 0.1(−0.07–0.9)  
Apgar scores 5 min
 Munoz [31] RCT Tdap -- (30–32) no vaccine Mean 8.9 (SD 0.2) 33 Mean 8.9 (SD 0.4) 15 MD 0 (−0.2–0.2)  
Abnormal conditions
 Munoz [31] RCT Tdap -- (30–32) no vaccine 3 (9.1)i 33 3 (20.0)j 15 0.5 (0.1–2.0)  
Congenital anomalies
 Munoz [31] RCT Tdap -- (30–32) no vaccine 1 (3.0)k 33 2 (13.3)l 15 0.2 (0.0–2.3)  
  1. RCT Randomised control trial, RCS Retrospective cohort study, RR Risk ratio, CI Confidence interval, MD mean difference (associated CI calculated based on a t-distribution), SD standard deviation, SGA Small-for-gestational-age, Tdap tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine, TT tetanus toxoid; no vaccine, not receiving Tdap or pertussis-containing vaccine during pregnancy, NA not applicable
  2. aEvents occurred within 30 days after injection
  3. bEvents occurred within 7 days after injection
  4. cConfidence interval cannot be calculated when one of the rates is zero
  5. dPreterm and term pre-eclampsia, and hypertension counted as hypertensive disorders
  6. eAdjusted for receipt of influenza vaccine, study site, and propensity score (which included sociodemographic characteristics [neighbourhood poverty index, age], presence of maternal comorbidities [hypertension, diabetes and cardiovascular or renal disease occurring prior to the start of pregnancy], receipt of medical care in the first trimester, and number of hospitalisations during the first 20 weeks of pregnancy as a surrogate of pregnancy complications)
  7. fEvents occurred within 42 days after injection
  8. gAdjusted for patterns of care prior to vaccination date/index date, perinatal care utilisation (as measured with the Kotelchuck Adequacy of Prenatal Care Utilization Index) and having an inpatient encounter before the vaccination date/index date
  9. hThe crude risk ratio presented here is not the value the original authors reported. Instead, the researcher of this review recalculated it. This correction was made based on the numbers of events (preterm births) in both Tdap-vaccinated and unvaccinated groups, as reported in the original article
  10. iAbnormal conditions at infant initial examination: Cephalohematoma (n = 2) and hydrocele (n = 1)
  11. jDecreased breath sounds with increased anteroposterior diameter (n = 1), laceration (n = 1), large for gestational age and heart murmur (n = 1)
  12. kBilateral renal pelviectasis (n = 1)
  13. 1Asymptomatic atrial or ventricular septal defect (n = 1) and cardiomyopathy (n = 1)