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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, 27–36

 

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)
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BMC Pregnancy and Childbirth

ISSN: 1471-2393

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